🔍 RecallPedia

Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms Reference Part Number (RPN): ZIMB-22-108 ZIMB-22-118 ZIMB-22-128 ZIMB-22-70 ZIMB-22-84 ZIMB-22-98 ZIMB-24-108 ZIMB-24-118 ZIMB-24-128 ZIMB-24-70 ZIMB-24-84 ZIMB-24-98 ZIMB-26-108 ZIMB-26-118 ZIMB-26-128 ZIMB-26-70 ZIMB-26-84 ZIMB-26-98 ZIMB-28-108 ZIMB-28-118 ZIMB-28-128 ZIMB-28-70 ZIMB-28-84 ZIMB-28-98 ZIMB-30-108 ZIMB-30-118 ZIMB-30-128 ZIMB-30-70 ZIMB-30-84 ZIMB-30-98 ZIMB-32-108 ZIMB-32-108 ZIMB-32-118 ZIMB-32-128 ZIMB-32-70 ZIMB-32-84 ZIMB-32-98 ZIMB-36-108 ZIMB-36-118 ZIMB-36-128 ZIMB-36-84 ZIMB-36-98

Class I - Dangerous
🏥 Medical Devices Recalled: August 11, 2020 Cook Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Reference Part / Lot Numbers : ZIMB-22-108 9182141, 9983461, 10010790, 10136649, 13023971; ZIMB-22-118 10077065; ZIMB-22-70 9170948, 9196501, 9196502, 9311502, 9415647, 10156546, 10275239, 10337923; ZIMB-22-84 9100087, 9100089, 9118160, 9124830, 9132423, 9182145, 9403140, 9415636, 9415637, 9964029,9964055, 9974798, 9974799, 10153964,10153965, 10337925; ZIMB-22-98 9108371, 9163902, 9406786, 10136631, 10275243; ZIMB-24-108 9338301, 9854089, 9936720, 9936722, 9939734, 9939736, 9945749, 9945751, 9945753, 10318498; ZIMB-24-118 9100111, 9163853, 9959252, 9995361, 9999386, 10275245; ZIMB-24-128 9136557; ZIMB-24-70 9084499, 9118179, 9118180, 9163859, 9184781, 9196487, 9196590, 9300915, 9311508, 9338304,9978260, 9978261, 9983464, 10291632,13023978; ZIMB-24-84 9084507, 9118182, 9118183, 9118406, 9118409, 9163906, 9181250, 9196491, 9196593, 9279116, 9292346, 9321079, 9321083, 9324519, 9324521,9330492, 9330493, 9338306, 9365311, 9409601, 9409602, 9409604, 9959219, 9964025, 9964027,9964028, 9983471, 10017280, 10044210,10141902, 10141911, 10175395, 10175409, 10291637, 10291638, 10305523, 10305524,10332829, 10340274, 10340279, 13008932,13011201, 13020521, 13035543, 13041249,10056663XX, NS9088555; ZIMB-24-98 9076897, 9080500, 9080501, 9084510, 9084512, 9100134, 9100135, 9102515, 9118415, 9173828, 9321095, 9365312, 9373635, 9415651, 9964064,9969873, 9974816, 10052850, 10077067, 10098962, 10151099, 10186652, 13041251; ZIMB-26-108 9100142, 9163915, 9373477, 9904753, 9915021, 9930826, 9936725, 9936733, 9936734, 9953748, 10010796, 10010836, 10025525, 10108021,10175397, 10299712, 10309872, 13023989, 13023990; ZIMB-26-118 9286115, 10105275, 10299413, 13011587,13023992; ZIMB-26-70 9100151, 9217933, 9373479, 9373646, 9419035, 9425597, 9425598, 9915028, 9915029, 9915030,9995377, 9999389, 10025531, 10077068,13011591, 13015424, 13021170, 13023993, 13027639; ZIMB-26-84 9076909, 9076928, 9088530, 9118164, 9124843, 9196498, 9303243, 9303253, 9314216, 9321168, 9415652, 9415653, 9936744, 9978265, 10010848,10025534, 10130408, 10130411, 10139153, 10153985, 10225101, 10227951, 10282883,10331451, 13008934, 13008935, 13011595,13023997, 13030103, 13035545, 13035546,13035549, 13090261, 10139146X; ZIMB-26-98 9076932, 9088524, 9100103, 9108359, 9124922, 9170952, 9170972, 9181256, 9209904, 9307498,9307687, 9307688, 9321171, 9321173, 9376513,9376514, 9376516, 9425605, 9425607, 9978273, 9999333, 10017283, 10056684, 10105282,10113546, 10144804, 10153990, 10153991,10153992, 10227946, 10231315, 10309875,10331463, 10331489, 10331490, 13011600,13015425, 13027049, 13090267; ZIMB-28-108 9040730, 9869684, 9920813, 9920814, 9920817, 9951131, 9969884, 9969885, 9983493, 9999335,10022608, 10044216, 10056686, 10108037,10307420, 10332830, 13010195, 13011603, 13044015, 13188317; ZIMB-28-118 9064897, 9303288, 9412815, 9415641, 9425608, 9923193, 9969889, 10010800, 10031214,10047286, 13011606, 13041262 ZIMB-28-128 9193964, 9383486, 9915023, 9971444, 9974773, 10119913, 10119918, 10305544, 13027650; ZIMB-28-70 9037693, 9056000, 9064899, 9064901, 9088565, 9167748, 9212286, 9217990, 9226370, 9307689,9330495, 9330496, 9331479, 9338361, 9338362,9415633, 9415638, 9415643, 9425610, 9425613, 9930818, 9964070, 9966894, 10037025,10139135, 10139159, 10283657; ZIMB-28-84 9046402, 9136667, 9167751, 9190117, 9193974, 9212287, 9217995, 9226355, 9279120, 9303293,9303294, 9311539, 9314218, 9324565, 9324566,9324569, 9376519, 9383491, 9383496, 9415665, 9423252, 9425615, 9425636, 9425640, 9909088,9911870, 9948685, 9948691, 9966896, 9966900,9969905, 9986400, 9999343, 10022614,10022616, 10044217, 10044219, 10047287,10051143, 10052841, 10052868, 10068425, 10105284, 10154429, 10175398, 10175399,10271375, 10288149, 10297330, 10325658,10337931, 13010196, 13011613, 13021173,13027655, 13050699, 13101560, 10141924X; ZIMB-28-98 9037752, 9046415, 9055991, 9064922, 9124929, 9124932, 9136670, 9143825, 9218000, 9234946,9283231, 9373486, 9373488, 9376523, 9383415,9383501, 9425633, 9911865, 9911867, 9913326, 9913327, 9920819, 9920820, 9948687, 9948692,9956372, 9982267, 10007633, 10059719,10059720, 10136638, 10332808, 13008942, 13010340, 13021175, 13021177, 13078502,13101562; ZIMB-30-108 9212304, 9307494, 9307701, 9361542, 9904221, 9911853, 9911860, 9966907, 9969909, 9978296,9982268, 9999348, 10013746, 10129802,10156556, 10223556, 13078507, 13078509, 9904230X, NS9218007; ZIMB-30-118 9040636, 9056086, 9415666, 9959246, 9999350, 10001828, 10013748, 10132963, 10156542, 10156558, 10163202; ZIMB-30-128 9136542, 9283236, 9307703, 10047290,10156560, 13020527, 13199408; ZIMB-30-70 9423255, 9904219, 9992839, 10007637, 10007638, 10037030, 10156561, 10327926,13012746, 9933334X; ZIMB-30-84 9053445, 9056095, 9060405, 9150335, 9185031, 9185032, 9185034, 9190254, 9292350, 9292355, 9334354, 9338287, 9404792, 9426588, 9930856, 9971412, 9971451, 10044221, 10051128, 10059685, 10098974, 10156565, 10156567, 10315171, 10315172, 13030115, 13030117, 13050689, 13094868; ZIMB-30-98 9037765, 9060395, 9060412, 9060414, 9193801, 9206515, 9212249, 9242441, 9933350, 9974777, 9982278, 9986414, 10007647, 10017296, 10037041, 10062767, 10062768, 10062770, 10119927, 10119928, 10119929, 10136643, 10156538, 10271379, 10315173, 10331468, 10343161, 13030124, 13032866, 13078512, 13105397, 10052870X ZIMB-32-108 9034048, 9060448, 9159951, 9159952, 9167820, 9283243, 9383406, 9945758, 9982284, 9983455, 9986419, 10126202, 10156568, 10337935; ZIMB-32-118 9143871, 9391316, 9917748, 9948669, 9982251, 9995331, 10136646, 13011206, 13014574; ZIMB-32-128 9037772, 9159955, 9361554, 9423265, 10156570; ZIMB-32-84 9040645, 9136551, 9159958, 9159959, 9159962, 9167828, 9193807, 9193809, 9239290, 9239292, 9242443, 9301043, 9330500, 9373494, 9391318, 9406725, 9406728, 9917759, 9951141, 9982291, 9986422, 9995339, 10007656, 10007660, 10013759, 10017297, 10017298, 10051126, 10051157, 10062699, 10062781, 10073701, 10077029, 10110453, 10156572, 10288184, 10297335, 10299417, 10307043, 13098184, 13105403; ZIMB-32-98 9060391, 9060393, 9088571, 9132417, 9201608, 9214705, 9217930, 9234937, 9234938, 9234939, 9286012, 9286110, 9307514, 9324523, 9406730, 9406733, 9406735, 9423268, 9936717, 9936719, 9974787, 9986425, 9999375, 10007664, 10013762, 10062785, 10077088, 10113555, 10126227, 10163191, 10163203, 10167625, 10335581, 13010201, 13030131, 13030132, 13030133, 13082901, 13105407; ZIMB-36-108 9130033, 9150330, 9159890, 9365255, 9386647, 9406737, 9406738, 9995345, 9999376, 10139139, 13030135, 13074793, 13082903; ZIMB-36-118 9132489, 9376500, 10129806, 10151121; ZIMB-36-128 9915031, 10090273; ZIMB-36-84 9132418, 9132427, 9132428, 9132496, 9184767, 9303240, 9330504, 9330505, 9406742, 9904232, 9974792, 10077064, 10307049, 13035572; ZIMB-36-98 9132500, 9391321, 9959249, 10110457, 10166133, 10167626, 10297331, 10331476.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Cook Inc.
Reason for Recall:
May contain excess glue within the handle of the delivery system, resulting in an inability to fully deploy the graft via the standard method or troubleshooting deployment method provided in the IFU
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms Reference Part Number (RPN): ZIMB-22-108 ZIMB-22-118 ZIMB-22-128 ZIMB-22-70 ZIMB-22-84 ZIMB-22-98 ZIMB-24-108 ZIMB-24-118 ZIMB-24-128 ZIMB-24-70 ZIMB-24-84 ZIMB-24-98 ZIMB-26-108 ZIMB-26-118 ZIMB-26-128 ZIMB-26-70 ZIMB-26-84 ZIMB-26-98 ZIMB-28-108 ZIMB-28-118 ZIMB-28-128 ZIMB-28-70 ZIMB-28-84 ZIMB-28-98 ZIMB-30-108 ZIMB-30-118 ZIMB-30-128 ZIMB-30-70 ZIMB-30-84 ZIMB-30-98 ZIMB-32-108 ZIMB-32-108 ZIMB-32-118 ZIMB-32-128 ZIMB-32-70 ZIMB-32-84 ZIMB-32-98 ZIMB-36-108 ZIMB-36-118 ZIMB-36-128 ZIMB-36-84 ZIMB-36-98

Product Codes/Lot Numbers:

Reference Part / Lot Numbers : ZIMB-22-108 9182141, 9983461, 10010790, 10136649, 13023971; ZIMB-22-118 10077065; ZIMB-22-70 9170948, 9196501, 9196502, 9311502, 9415647, 10156546, 10275239, 10337923; ZIMB-22-84 9100087, 9100089, 9118160, 9124830, 9132423, 9182145, 9403140, 9415636, 9415637, 9964029,9964055, 9974798, 9974799, 10153964,10153965, 10337925; ZIMB-22-98 9108371, 9163902, 9406786, 10136631, 10275243; ZIMB-24-108 9338301, 9854089, 9936720, 9936722, 9939734, 9939736, 9945749, 9945751, 9945753, 10318498; ZIMB-24-118 9100111, 9163853, 9959252, 9995361, 9999386, 10275245; ZIMB-24-128 9136557; ZIMB-24-70 9084499, 9118179, 9118180, 9163859, 9184781, 9196487, 9196590, 9300915, 9311508, 9338304,9978260, 9978261, 9983464, 10291632,13023978; ZIMB-24-84 9084507, 9118182, 9118183, 9118406, 9118409, 9163906, 9181250, 9196491, 9196593, 9279116, 9292346, 9321079, 9321083, 9324519, 9324521,9330492, 9330493, 9338306, 9365311, 9409601, 9409602, 9409604, 9959219, 9964025, 9964027,9964028, 9983471, 10017280, 10044210,10141902, 10141911, 10175395, 10175409, 10291637, 10291638, 10305523, 10305524,10332829, 10340274, 10340279, 13008932,13011201, 13020521, 13035543, 13041249,10056663XX, NS9088555; ZIMB-24-98 9076897, 9080500, 9080501, 9084510, 9084512, 9100134, 9100135, 9102515, 9118415, 9173828, 9321095, 9365312, 9373635, 9415651, 9964064,9969873, 9974816, 10052850, 10077067, 10098962, 10151099, 10186652, 13041251; ZIMB-26-108 9100142, 9163915, 9373477, 9904753, 9915021, 9930826, 9936725, 9936733, 9936734, 9953748, 10010796, 10010836, 10025525, 10108021,10175397, 10299712, 10309872, 13023989, 13023990; ZIMB-26-118 9286115, 10105275, 10299413, 13011587,13023992; ZIMB-26-70 9100151, 9217933, 9373479, 9373646, 9419035, 9425597, 9425598, 9915028, 9915029, 9915030,9995377, 9999389, 10025531, 10077068,13011591, 13015424, 13021170, 13023993, 13027639; ZIMB-26-84 9076909, 9076928, 9088530, 9118164, 9124843, 9196498, 9303243, 9303253, 9314216, 9321168, 9415652, 9415653, 9936744, 9978265, 10010848,10025534, 10130408, 10130411, 10139153, 10153985, 10225101, 10227951, 10282883,10331451, 13008934, 13008935, 13011595,13023997, 13030103, 13035545, 13035546,13035549, 13090261, 10139146X; ZIMB-26-98 9076932, 9088524, 9100103, 9108359, 9124922, 9170952, 9170972, 9181256, 9209904, 9307498,9307687, 9307688, 9321171, 9321173, 9376513,9376514, 9376516, 9425605, 9425607, 9978273, 9999333, 10017283, 10056684, 10105282,10113546, 10144804, 10153990, 10153991,10153992, 10227946, 10231315, 10309875,10331463, 10331489, 10331490, 13011600,13015425, 13027049, 13090267; ZIMB-28-108 9040730, 9869684, 9920813, 9920814, 9920817, 9951131, 9969884, 9969885, 9983493, 9999335,10022608, 10044216, 10056686, 10108037,10307420, 10332830, 13010195, 13011603, 13044015, 13188317; ZIMB-28-118 9064897, 9303288, 9412815, 9415641, 9425608, 9923193, 9969889, 10010800, 10031214,10047286, 13011606, 13041262 ZIMB-28-128 9193964, 9383486, 9915023, 9971444, 9974773, 10119913, 10119918, 10305544, 13027650; ZIMB-28-70 9037693, 9056000, 9064899, 9064901, 9088565, 9167748, 9212286, 9217990, 9226370, 9307689,9330495, 9330496, 9331479, 9338361, 9338362,9415633, 9415638, 9415643, 9425610, 9425613, 9930818, 9964070, 9966894, 10037025,10139135, 10139159, 10283657; ZIMB-28-84 9046402, 9136667, 9167751, 9190117, 9193974, 9212287, 9217995, 9226355, 9279120, 9303293,9303294, 9311539, 9314218, 9324565, 9324566,9324569, 9376519, 9383491, 9383496, 9415665, 9423252, 9425615, 9425636, 9425640, 9909088,9911870, 9948685, 9948691, 9966896, 9966900,9969905, 9986400, 9999343, 10022614,10022616, 10044217, 10044219, 10047287,10051143, 10052841, 10052868, 10068425, 10105284, 10154429, 10175398, 10175399,10271375, 10288149, 10297330, 10325658,10337931, 13010196, 13011613, 13021173,13027655, 13050699, 13101560, 10141924X; ZIMB-28-98 9037752, 9046415, 9055991, 9064922, 9124929, 9124932, 9136670, 9143825, 9218000, 9234946,9283231, 9373486, 9373488, 9376523, 9383415,9383501, 9425633, 9911865, 9911867, 9913326, 9913327, 9920819, 9920820, 9948687, 9948692,9956372, 9982267, 10007633, 10059719,10059720, 10136638, 10332808, 13008942, 13010340, 13021175, 13021177, 13078502,13101562; ZIMB-30-108 9212304, 9307494, 9307701, 9361542, 9904221, 9911853, 9911860, 9966907, 9969909, 9978296,9982268, 9999348, 10013746, 10129802,10156556, 10223556, 13078507, 13078509, 9904230X, NS9218007; ZIMB-30-118 9040636, 9056086, 9415666, 9959246, 9999350, 10001828, 10013748, 10132963, 10156542, 10156558, 10163202; ZIMB-30-128 9136542, 9283236, 9307703, 10047290,10156560, 13020527, 13199408; ZIMB-30-70 9423255, 9904219, 9992839, 10007637, 10007638, 10037030, 10156561, 10327926,13012746, 9933334X; ZIMB-30-84 9053445, 9056095, 9060405, 9150335, 9185031, 9185032, 9185034, 9190254, 9292350, 9292355, 9334354, 9338287, 9404792, 9426588, 9930856, 9971412, 9971451, 10044221, 10051128, 10059685, 10098974, 10156565, 10156567, 10315171, 10315172, 13030115, 13030117, 13050689, 13094868; ZIMB-30-98 9037765, 9060395, 9060412, 9060414, 9193801, 9206515, 9212249, 9242441, 9933350, 9974777, 9982278, 9986414, 10007647, 10017296, 10037041, 10062767, 10062768, 10062770, 10119927, 10119928, 10119929, 10136643, 10156538, 10271379, 10315173, 10331468, 10343161, 13030124, 13032866, 13078512, 13105397, 10052870X ZIMB-32-108 9034048, 9060448, 9159951, 9159952, 9167820, 9283243, 9383406, 9945758, 9982284, 9983455, 9986419, 10126202, 10156568, 10337935; ZIMB-32-118 9143871, 9391316, 9917748, 9948669, 9982251, 9995331, 10136646, 13011206, 13014574; ZIMB-32-128 9037772, 9159955, 9361554, 9423265, 10156570; ZIMB-32-84 9040645, 9136551, 9159958, 9159959, 9159962, 9167828, 9193807, 9193809, 9239290, 9239292, 9242443, 9301043, 9330500, 9373494, 9391318, 9406725, 9406728, 9917759, 9951141, 9982291, 9986422, 9995339, 10007656, 10007660, 10013759, 10017297, 10017298, 10051126, 10051157, 10062699, 10062781, 10073701, 10077029, 10110453, 10156572, 10288184, 10297335, 10299417, 10307043, 13098184, 13105403; ZIMB-32-98 9060391, 9060393, 9088571, 9132417, 9201608, 9214705, 9217930, 9234937, 9234938, 9234939, 9286012, 9286110, 9307514, 9324523, 9406730, 9406733, 9406735, 9423268, 9936717, 9936719, 9974787, 9986425, 9999375, 10007664, 10013762, 10062785, 10077088, 10113555, 10126227, 10163191, 10163203, 10167625, 10335581, 13010201, 13030131, 13030132, 13030133, 13082901, 13105407; ZIMB-36-108 9130033, 9150330, 9159890, 9365255, 9386647, 9406737, 9406738, 9995345, 9999376, 10139139, 13030135, 13074793, 13082903; ZIMB-36-118 9132489, 9376500, 10129806, 10151121; ZIMB-36-128 9915031, 10090273; ZIMB-36-84 9132418, 9132427, 9132428, 9132496, 9184767, 9303240, 9330504, 9330505, 9406742, 9904232, 9974792, 10077064, 10307049, 13035572; ZIMB-36-98 9132500, 9391321, 9959249, 10110457, 10166133, 10167626, 10297331, 10331476.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2964-2020

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