PROPONENT SR SL (Model L200)

Class I - Dangerous

🏥 Medical Devices Recalled: August 20, 2025 Boston Scientific Other Medical Devices

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GTIN 00802526559020, Serial numbers: 722605, 722614, 722634, 722647. GTIN 00802526576362, Serial numbers: 464359, 464382, 464387, 464444, 464447, 464457, 464462, 464471, 464505, 464511, 464514, 464517, 464521, 464525, 464527, 464541, 464549, 464552, 464554, 464561, 464576, 708351, 708451, 708466, 708471, 708495, 708513, 708514, 708515, 708516, 708517, 708525, 708529, 708532, 708533, 708536, 708618, 708619, 708620, 708622, 708623, 708624, 708625, 708627, 708630, 708651, 708653, 708654, 708655, 708656, 708658, 708660, 708737, 708751, 708764, 708783, 708816, 708824, 708826, 708857, 708862, 708867, 708868, 708879, 708880, 708885, 708887, 708889, 708894, 708898, 708912, 708920, 708922, 708924, 708929, 708939, 708942, 708944, 708945, 708946, 708947, 708948, 708949, 708952, 708959, 708960, 708967, 708968, 708969, 708976, 708980, 708983, 708997, 709003, 709009, 709011, 709015, 709024, 709025, 709037, 709040, 709041, 710248, 710517, 710627, 710705, 710754, 710765, 710771, 710772, 710788, 710789, 710790, 710824, 710825, 710831, 710889, 710905, 710907, 710910, 710916, 710931, 710954, 710980, 711315, 711412, 711640, 711655, 714062, 714644, 714688, 714708, 715328, 717903, 717931, 717934, 717941, 717948, 717950, 717951, 717965, 717976, 717981, 717982, 717992, 718007, 718009, 718138, 718522, 718780, 718783, 718937, 720309, 720504, 720556, 720597, 720650, 721983, 721991, 722012, 722438, 722565, 722689, 722724, 722756, 722967, 723456, 724170, 724319, 724398, 724404, 724485, 724623, 725175, 725182, 725198, 725262, 725272, 725283, 725363, 725365, 725368, 725370, 725371, 725372, 725373, 725383, 725388, 725389, 725390, 725392, 725404, 725409, 725418, 725419, 725425, 725444, 727098, 728855, 728893, 728894, 728917, 728922, 729054, 729410, 729411, 729413, 729421, 729589, 729599, 729602, 731110, 731612, 734834. GTIN 00802526578007, Serial Numbers: 464370, 464388, 464446, 464452, 464458, 464460, 464467, 464468, 464470, 464475, 464477, 464481, 464482, 464483, 464486, 464490, 464491, 464492, 464498, 464500, 464501, 464506, 464508, 464512, 464516, 464519, 464523, 464526, 464528, 464532, 464563, 464568, 464570, 464590, 705011, 705236, 705383, 705409, 705419, 705462, 705468, 705555, 705576, 705584, 705622, 705628, 705702, 705706, 705711, 705713, 705728, 705751, 705753, 705795, 705812, 706007, 706098, 706215, 706321, 706350, 706372, 706698, 706846, 706879, 706918, 706923, 706931, 706947, 706967, 707053, 707069, 707089, 707138, 707173, 708261, 708473, 708494, 708504, 708528, 708534, 708546, 708549, 708585, 708589, 708595, 708629, 708652, 708657, 708721, 708722, 708723, 708749, 708750, 708752, 708770, 708774, 708775, 708776, 708780, 708797, 708798, 708802, 708815, 708819, 708820, 708831, 708832, 708841, 708843, 708844, 708848, 708851, 708853, 708858, 708859, 708874, 708877, 708883, 708886, 708892, 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733536, 733537, 733539, 733540, 733926, 733954, 733961, 734000, 734423, 734499, 734508, 734514, 734535, 734563, 734575, 734676, 734682, 734729, 734842, 734886, 734979, 734986, 734989, 734997, 735022, 735024, 735032, 735037, 735038, 735047, 735051, 735055, 735061, 735062, 735063, 735066, 735070, 735075, 735078, 735084, 735094, 735604.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
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:: Boston Scientific Corporation
Reason for Recall:: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

PROPONENT SR SL (Model L200)

Product Codes/Lot Numbers:

GTIN 00802526559020, Serial numbers: 722605, 722614, 722634, 722647. GTIN 00802526576362, Serial numbers: 464359, 464382, 464387, 464444, 464447, 464457, 464462, 464471, 464505, 464511, 464514, 464517, 464521, 464525, 464527, 464541, 464549, 464552, 464554, 464561, 464576, 708351, 708451, 708466, 708471, 708495, 708513, 708514, 708515, 708516, 708517, 708525, 708529, 708532, 708533, 708536, 708618, 708619, 708620, 708622, 708623, 708624, 708625, 708627, 708630, 708651, 708653, 708654, 708655, 708656, 708658, 708660, 708737, 708751, 708764, 708783, 708816, 708824, 708826, 708857, 708862, 708867, 708868, 708879, 708880, 708885, 708887, 708889, 708894, 708898, 708912, 708920, 708922, 708924, 708929, 708939, 708942, 708944, 708945, 708946, 708947, 708948, 708949, 708952, 708959, 708960, 708967, 708968, 708969, 708976, 708980, 708983, 708997, 709003, 709009, 709011, 709015, 709024, 709025, 709037, 709040, 709041, 710248, 710517, 710627, 710705, 710754, 710765, 710771, 710772, 710788, 710789, 710790, 710824, 710825, 710831, 710889, 710905, 710907, 710910, 710916, 710931, 710954, 710980, 711315, 711412, 711640, 711655, 714062, 714644, 714688, 714708, 715328, 717903, 717931, 717934, 717941, 717948, 717950, 717951, 717965, 717976, 717981, 717982, 717992, 718007, 718009, 718138, 718522, 718780, 718783, 718937, 720309, 720504, 720556, 720597, 720650, 721983, 721991, 722012, 722438, 722565, 722689, 722724, 722756, 722967, 723456, 724170, 724319, 724398, 724404, 724485, 724623, 725175, 725182, 725198, 725262, 725272, 725283, 725363, 725365, 725368, 725370, 725371, 725372, 725373, 725383, 725388, 725389, 725390, 725392, 725404, 725409, 725418, 725419, 725425, 725444, 727098, 728855, 728893, 728894, 728917, 728922, 729054, 729410, 729411, 729413, 729421, 729589, 729599, 729602, 731110, 731612, 734834. GTIN 00802526578007, Serial Numbers: 464370, 464388, 464446, 464452, 464458, 464460, 464467, 464468, 464470, 464475, 464477, 464481, 464482, 464483, 464486, 464490, 464491, 464492, 464498, 464500, 464501, 464506, 464508, 464512, 464516, 464519, 464523, 464526, 464528, 464532, 464563, 464568, 464570, 464590, 705011, 705236, 705383, 705409, 705419, 705462, 705468, 705555, 705576, 705584, 705622, 705628, 705702, 705706, 705711, 705713, 705728, 705751, 705753, 705795, 705812, 706007, 706098, 706215, 706321, 706350, 706372, 706698, 706846, 706879, 706918, 706923, 706931, 706947, 706967, 707053, 707069, 707089, 707138, 707173, 708261, 708473, 708494, 708504, 708528, 708534, 708546, 708549, 708585, 708589, 708595, 708629, 708652, 708657, 708721, 708722, 708723, 708749, 708750, 708752, 708770, 708774, 708775, 708776, 708780, 708797, 708798, 708802, 708815, 708819, 708820, 708831, 708832, 708841, 708843, 708844, 708848, 708851, 708853, 708858, 708859, 708874, 708877, 708883, 708886, 708892, 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Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0085-2026

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