🔍 RecallPedia

RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX

Class I - Dangerous
🏥 Medical Devices Recalled: December 20, 2022 Bolton Medical Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI/DI 00843576100268: REF 28-M4-22-190-22S, Lot Numbers: B210925203 UDI/DI 00843576149731, REF 28-M4-24-150-24U, Lot Numbers: 2204210015, 2208250004, 2208250003; UDI/DI 00843576149618, REF 28-M4-26-095-26U, Lot Numbers: 2112210189; UDI/DI 00843576149748, REF 28-M4-26-155-26U, Lot Numbers: 2208240053, 2208250164, 2208220204; UDI/DI 00843576100039, REF 28-M4-28-095-28S, Lot Numbers: B220211367, B220129307, B220211163; UDI/DI 00843576149625, REF 28-M4-28-095-28U, Lot Numbers: 2208220081; UDI/DI 00843576150119, REF 28-M4-28-155-24U, Lot Numbers: 2210110060, 2202150279, 2202150279; UDI/DI 00843576100169, REF 28-M4-28-155-28S, Lot Numbers: B220209262; UDI/DI 00843576149755, REF 28-M4-28-155-28U, Lot Numbers: 2208240183; UDI/DI 00843576150218, REF 28-M4-28-195-24U, Lot Numbers: 2202030119; UDI/DI 00843576149885, REF 28-M4-28-195-28U, Lot Numbers: 2109150299; UDI/DI 00843576150317, REF 28-M4-28-250-24U, Lot Numbers: 2202100029; UDI/DI 00843576150010, REF 28-M4-28-250-28U, Lot Numbers: 2202010127; UDI/DI 00843576100046, REF 28-M4-30-095-30S, Lot Numbers: B220228338; UDI/DI 00843576149632, REF 28-M4-30-095-30U, Lot Numbers: 2208240127, 2112140029, 2202070140; UDI/DI 00843576150126, REF 28-M4-30-155-26U, Lot Numbers: 2203080218; UDI/DI 00843576100176, REF 28-M4-30-155-30S, Lot Numbers: B220825157, B211229047, B220211164, B211228037; UDI/DI 00843576149762, REF 28-M4-30-155-30U, Lot Numbers: 2202100215, 2208240129; UDI/DI 00843576100633, REF 28-M4-30-200-26S, Lot Numbers: B220207438; UDI/DI 00843576100305, REF 28-M4-30-200-30S, Lot Numbers: B220118082; UDI/DI 00843576100732, REF 28-M4-30-250-26S, Lot Numbers: B220202152; UDI/DI 00843576150027, REF 28-M4-30-250-30U, Lot Numbers: 2202030116; UDI/DI 00843576100053, REF 28-M4-32-095-32S, Lot Numbers: B210910015; UDI/DI 00843576100541, REF 28-M4-32-155-28S, Lot Numbers: B220301231; UDI/DI 00843576100183, REF 28-M4-32-155-32S, Lot Numbers: B220216239; UDI/DI 00843576149779, REF 28-M4-32-155-32U, Lot Numbers: 2202100265, 2202110370; UDI/DI 00843576100640, REF 28-M4-32-200-28S, Lot Numbers: B210626308, B210626307; UDI/DI 00843576100749, REF 28-M4-32-250-28S, Lot Numbers: B211222146; UDI/DI 00843576150331, REF 28-M4-32-250-28U, Lot Numbers: 2110120002; UDI/DI 00843576150034, REF 28-M4-32-250-32U, Lot Numbers: 2112180035; UDI/DI 00843576149656, REF 28-M4-34-100-34U, Lot Numbers: 2112110191, 2202120100, 2208230097; UDI/DI 00843576100558, REF 28-M4-34-145-30S, Lot Numbers: B210609033; UDI/DI 00843576150140, REF 28-M4-34-145-30U, Lot Numbers: 2210110037; UDI/DI 00843576100190, REF 28-M4-34-145-34S, Lot Numbers: B220210184, B211012027, B220210028, B220216053, B220216053, B220209191; UDI/DI 00843576149786, REF 28-M4-34-145-34U, Lot Numbers: 2110120028, 2109150326, 2109140012, 2110120025, 2208240141, 2208240140, 2208240126, 2208240029, 2208240030, 2208250006, 2208250005, 2112280069, 2201280546, 2202080066; UDI/DI 00843576100657, REF 28-M4-34-200-30S, Lot Numbers: B210430260, B220217323, B220216055, B220217319, B211222145, B220216055, B210430262, B220216054; UDI/DI 00843576150249, REF 28-M4-34-200-30U, Lot Numbers: 2202260090; UDI/DI 00843576100329, REF 28-M4-34-200-34S, Lot Numbers: B210428257, B211014252; UDI/DI 00843576149915, REF 28-M4-34-200-34U, Lot Numbers: 2202170286, 2202170286, 2202170219, 2202170278, 2202160200, 2202160200; UDI/DI 00843576100756, REF 28-M4-34-250-30S, Lot Numbers: B211221199; UDI/DI 00843576100077, REF 28-M4-36-100-36S, Lot Numbers: B220217276, B220217276; UDI/DI 00843576100206, REF 28-M4-36-145-36S, Lot Numbers: B221025248; UDI/DI 00843576100664, REF 28-M4-36-190-32S, Lot Numbers: B210622126, B221025300; UDI/DI 00843576100763, REF 28-M4-36-250-32S, Lot Numbers: B221007313; UDI/DI 00843576150058, REF 28-M4-36-250-36U, Lot Numbers: 2210110276, 2210100191; UDI/DI 00843576100084, REF 28-M4-38-100-38S, Lot Numbers: B220824128; UDI/DI 00843576150164, REF 28-M4-38-145-34U, Lot Numbers: 2202170235; UDI/DI 00843576100213, REF 28-M4-38-145-38S, Lot Numbers: B221026208; UDI/DI 00843576100671, REF 28-M4-38-190-34S, Lot Numbers: B220121067, B220317294; UDI/DI 00843576150263, REF 28-M4-38-190-34U, Lot Numbers: 2204140072; UDI/DI 00843576100473, REF 28-M4-38-250-38S, Lot Numbers: B220825007; UDI/DI 00843576100091, REF 28-M4-40-105-40S, Lot Numbers: B220216195, B220216195, B220125193; UDI/DI 00843576149687, REF 28-M4-40-105-40U, Lot Numbers: 2202160194; UDI/DI 00843576100589, REF 28-M4-40-145-36S, Lot Numbers: B220825008; UDI/DI 00843576100350, REF 28-M4-40-195-40S, Lot Numbers: B220222125, B220222125, B220216224, B220223318, B220223318, B220216224; UDI/DI 00843576100787, REF 28-M4-40-250-36S, Lot Numbers: B221025298; UDI/DI 00843576150379, REF 28-M4-40-250-36U, Lot Numbers: 2203010243; UDI/DI 00843576149694, REF 28-M4-42-105-42U, Lot Numbers: 2109100260; UDI/DI 00843576100596, REF 28-M4-42-150-38S, Lot Numbers: B220115098; UDI/DI 00843576100695, REF 28-M4-42-195-38S, Lot Numbers: B220420138; UDI/DI 00843576149700, REF 28-M4-44-105-44U, Lot Numbers: 2201170430; UDI/DI 00843576100602, REF 28-M4-44-155-40S, Lot Numbers: B220117359; UDI/DI 00843576100701, REF 28-M4-44-200-40S, Lot Numbers: B220121070; UDI/DI 00843576100374, REF 28-M4-44-200-44S, Lot Numbers: B220824149, B211229052, B220115095; UDI/DI 00843576150393, REF 28-M4-44-250-40U, Lot Numbers: 2201170418; UDI/DI 00843576150096, REF 28-M4-44-250-44U, Lot Numbers: 2112130139; UDI/DI 00843576100121, REF 28-M4-46-105-46S, Lot Numbers: B211203109; UDI/DI 00843576149717, REF 28-M4-46-105-46U, Lot Numbers: 2203030290; UDI/DI 00843576100718, REF 28-M4-46-200-42S, Lot Numbers: B220825037; UDI/DI 00843576100381, REF 28-M4-46-200-46S, Lot Numbers: B220825038; UDI/DI 00843576149977, REF 28-M4-46-200-46U, Lot Numbers: 2204200130; UDI/DI 00843576100510, REF 28-M4-46-250-46S, Lot Numbers: B210525287.
  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:
Bolton Medical Inc.
Reason for Recall:
The product may be shorter than packaging indicates
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX

Product Codes/Lot Numbers:

UDI/DI 00843576100268: REF 28-M4-22-190-22S, Lot Numbers: B210925203 UDI/DI 00843576149731, REF 28-M4-24-150-24U, Lot Numbers: 2204210015, 2208250004, 2208250003; UDI/DI 00843576149618, REF 28-M4-26-095-26U, Lot Numbers: 2112210189; UDI/DI 00843576149748, REF 28-M4-26-155-26U, Lot Numbers: 2208240053, 2208250164, 2208220204; UDI/DI 00843576100039, REF 28-M4-28-095-28S, Lot Numbers: B220211367, B220129307, B220211163; UDI/DI 00843576149625, REF 28-M4-28-095-28U, Lot Numbers: 2208220081; UDI/DI 00843576150119, REF 28-M4-28-155-24U, Lot Numbers: 2210110060, 2202150279, 2202150279; UDI/DI 00843576100169, REF 28-M4-28-155-28S, Lot Numbers: B220209262; UDI/DI 00843576149755, REF 28-M4-28-155-28U, Lot Numbers: 2208240183; UDI/DI 00843576150218, REF 28-M4-28-195-24U, Lot Numbers: 2202030119; UDI/DI 00843576149885, REF 28-M4-28-195-28U, Lot Numbers: 2109150299; UDI/DI 00843576150317, REF 28-M4-28-250-24U, Lot Numbers: 2202100029; UDI/DI 00843576150010, REF 28-M4-28-250-28U, Lot Numbers: 2202010127; UDI/DI 00843576100046, REF 28-M4-30-095-30S, Lot Numbers: B220228338; UDI/DI 00843576149632, REF 28-M4-30-095-30U, Lot Numbers: 2208240127, 2112140029, 2202070140; UDI/DI 00843576150126, REF 28-M4-30-155-26U, Lot Numbers: 2203080218; UDI/DI 00843576100176, REF 28-M4-30-155-30S, Lot Numbers: B220825157, B211229047, B220211164, B211228037; UDI/DI 00843576149762, REF 28-M4-30-155-30U, Lot Numbers: 2202100215, 2208240129; UDI/DI 00843576100633, REF 28-M4-30-200-26S, Lot Numbers: B220207438; UDI/DI 00843576100305, REF 28-M4-30-200-30S, Lot Numbers: B220118082; UDI/DI 00843576100732, REF 28-M4-30-250-26S, Lot Numbers: B220202152; UDI/DI 00843576150027, REF 28-M4-30-250-30U, Lot Numbers: 2202030116; UDI/DI 00843576100053, REF 28-M4-32-095-32S, Lot Numbers: B210910015; UDI/DI 00843576100541, REF 28-M4-32-155-28S, Lot Numbers: B220301231; UDI/DI 00843576100183, REF 28-M4-32-155-32S, Lot Numbers: B220216239; UDI/DI 00843576149779, REF 28-M4-32-155-32U, Lot Numbers: 2202100265, 2202110370; UDI/DI 00843576100640, REF 28-M4-32-200-28S, Lot Numbers: B210626308, B210626307; UDI/DI 00843576100749, REF 28-M4-32-250-28S, Lot Numbers: B211222146; UDI/DI 00843576150331, REF 28-M4-32-250-28U, Lot Numbers: 2110120002; UDI/DI 00843576150034, REF 28-M4-32-250-32U, Lot Numbers: 2112180035; UDI/DI 00843576149656, REF 28-M4-34-100-34U, Lot Numbers: 2112110191, 2202120100, 2208230097; UDI/DI 00843576100558, REF 28-M4-34-145-30S, Lot Numbers: B210609033; UDI/DI 00843576150140, REF 28-M4-34-145-30U, Lot Numbers: 2210110037; UDI/DI 00843576100190, REF 28-M4-34-145-34S, Lot Numbers: B220210184, B211012027, B220210028, B220216053, B220216053, B220209191; UDI/DI 00843576149786, REF 28-M4-34-145-34U, Lot Numbers: 2110120028, 2109150326, 2109140012, 2110120025, 2208240141, 2208240140, 2208240126, 2208240029, 2208240030, 2208250006, 2208250005, 2112280069, 2201280546, 2202080066; UDI/DI 00843576100657, REF 28-M4-34-200-30S, Lot Numbers: B210430260, B220217323, B220216055, B220217319, B211222145, B220216055, B210430262, B220216054; UDI/DI 00843576150249, REF 28-M4-34-200-30U, Lot Numbers: 2202260090; UDI/DI 00843576100329, REF 28-M4-34-200-34S, Lot Numbers: B210428257, B211014252; UDI/DI 00843576149915, REF 28-M4-34-200-34U, Lot Numbers: 2202170286, 2202170286, 2202170219, 2202170278, 2202160200, 2202160200; UDI/DI 00843576100756, REF 28-M4-34-250-30S, Lot Numbers: B211221199; UDI/DI 00843576100077, REF 28-M4-36-100-36S, Lot Numbers: B220217276, B220217276; UDI/DI 00843576100206, REF 28-M4-36-145-36S, Lot Numbers: B221025248; UDI/DI 00843576100664, REF 28-M4-36-190-32S, Lot Numbers: B210622126, B221025300; UDI/DI 00843576100763, REF 28-M4-36-250-32S, Lot Numbers: B221007313; UDI/DI 00843576150058, REF 28-M4-36-250-36U, Lot Numbers: 2210110276, 2210100191; UDI/DI 00843576100084, REF 28-M4-38-100-38S, Lot Numbers: B220824128; UDI/DI 00843576150164, REF 28-M4-38-145-34U, Lot Numbers: 2202170235; UDI/DI 00843576100213, REF 28-M4-38-145-38S, Lot Numbers: B221026208; UDI/DI 00843576100671, REF 28-M4-38-190-34S, Lot Numbers: B220121067, B220317294; UDI/DI 00843576150263, REF 28-M4-38-190-34U, Lot Numbers: 2204140072; UDI/DI 00843576100473, REF 28-M4-38-250-38S, Lot Numbers: B220825007; UDI/DI 00843576100091, REF 28-M4-40-105-40S, Lot Numbers: B220216195, B220216195, B220125193; UDI/DI 00843576149687, REF 28-M4-40-105-40U, Lot Numbers: 2202160194; UDI/DI 00843576100589, REF 28-M4-40-145-36S, Lot Numbers: B220825008; UDI/DI 00843576100350, REF 28-M4-40-195-40S, Lot Numbers: B220222125, B220222125, B220216224, B220223318, B220223318, B220216224; UDI/DI 00843576100787, REF 28-M4-40-250-36S, Lot Numbers: B221025298; UDI/DI 00843576150379, REF 28-M4-40-250-36U, Lot Numbers: 2203010243; UDI/DI 00843576149694, REF 28-M4-42-105-42U, Lot Numbers: 2109100260; UDI/DI 00843576100596, REF 28-M4-42-150-38S, Lot Numbers: B220115098; UDI/DI 00843576100695, REF 28-M4-42-195-38S, Lot Numbers: B220420138; UDI/DI 00843576149700, REF 28-M4-44-105-44U, Lot Numbers: 2201170430; UDI/DI 00843576100602, REF 28-M4-44-155-40S, Lot Numbers: B220117359; UDI/DI 00843576100701, REF 28-M4-44-200-40S, Lot Numbers: B220121070; UDI/DI 00843576100374, REF 28-M4-44-200-44S, Lot Numbers: B220824149, B211229052, B220115095; UDI/DI 00843576150393, REF 28-M4-44-250-40U, Lot Numbers: 2201170418; UDI/DI 00843576150096, REF 28-M4-44-250-44U, Lot Numbers: 2112130139; UDI/DI 00843576100121, REF 28-M4-46-105-46S, Lot Numbers: B211203109; UDI/DI 00843576149717, REF 28-M4-46-105-46U, Lot Numbers: 2203030290; UDI/DI 00843576100718, REF 28-M4-46-200-42S, Lot Numbers: B220825037; UDI/DI 00843576100381, REF 28-M4-46-200-46S, Lot Numbers: B220825038; UDI/DI 00843576149977, REF 28-M4-46-200-46U, Lot Numbers: 2204200130; UDI/DI 00843576100510, REF 28-M4-46-250-46S, Lot Numbers: B210525287.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0997-2023

Related Recalls

RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Part number 28-M4-34-100-34U; (b) Part number 28-M4-30-095-30U; (c) Part number 28-M4-46-155-46U; (d) Part number 28-M4-32-155-32S; (e) Part number 28-M4-36-250-32S; (f) Part number 28-M4-38-145-34S; (g) Part number 28-M4-38-190-38S; (h) Part number 28-M4-44-105-44S; (i) Part number 28-N4-22-099-22S; (j) Part number 28-N4-22-159-22S; (k) Part number 28-N4-24-099-24S; (l) Part number 28-N4-28-204-24S (m) Part number 28-N4-30-164-30U; (n) Part number 28-N4-32-164-28S; (o) Part number 28-N4-34-154-34U; (p) Part number 28-N4-34-209-30S; (q) RELAY PRO Custom-Made Device, REF 28NC36N19038S2590, part number 28-CMP-3062-NC; and (r) RELAY PRO Custom-Made Device, REF 28MC36A17536S2390, part number 28-CMP-3074-MC;

Bolton Medical

Class I - Dangerous

The stent-graft inside the delivery system was the incorrect size.

Feb 22, 2024 Implants & Prosthetics Nationwide View Details →

The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Graft, a Proximal Cuff Stent-Graft and a Straight Iliac Extension Stent-Graft. Each stent-graft is preloaded into its own delivery system that is advanced under fluoroscopy to the location of the infrarenal aneurysm. The stent-graft is deployed at the intended location and creates a blood flow channel, excluding the aneurysm from blood pressure and flow.

Bolton Medical

Class I - Dangerous

Potential for the incorrect size stent-graft than the printed carton label.

May 3, 2023 Implants & Prosthetics Nationwide View Details →