Medical DeviceJul 8, 2026
Boston Scientific CRE Wireguided 12-15mm 240cm recall — FDA Z-2635-2026
Potential sterile breach of the pouches in which devices are packaged.
Class IIFDA: OngoingBoston Scientific Corporation
Recall history in this database
Classification mix: Class II: 337, Class I: 121, Class III: 5.
Medical DeviceJul 8, 2026
Boston Scientific CRE Wireguided 15-18mm 240cm recall — FDA Z-2636-2026
Potential sterile breach of the pouches in which devices are packaged.
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceJul 8, 2026
Boston Scientific CRE Wireguided 6-8mm 240cm recall — FDA Z-2632-2026
Potential sterile breach of the pouches in which devices are packaged.
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceJul 8, 2026
Boston Scientific CRE Wireguided 18-20mm 240cm recall — FDA Z-2637-2026
Potential sterile breach of the pouches in which devices are packaged.
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceJul 8, 2026
Boston Scientific CRE Pro Wireguided 8-10mm 240cm recall — FDA Z-2627-2026
Potential sterile breach of the pouches in which devices are packaged.
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceJul 8, 2026
Boston Scientific CRE Wireguided 10-12mm 240cm recall — FDA Z-2634-2026
Potential sterile breach of the pouches in which devices are packaged.
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceJul 8, 2026
Boston Scientific CRE Pro Wireguided 18-20mm 240cm recall — FDA Z-2631-2026
Potential sterile breach of the pouches in which devices are packaged.
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceJun 17, 2026
Boston Scientific Orca Single Use Air/Water and Suction Valves, Material Number (UPN) recall — FDA Z-2413-2026
Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMay 13, 2026
Boston Scientific LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW recall — FDA Z-2048-2026
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and…
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMay 13, 2026
Boston Scientific LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW recall — FDA Z-2049-2026
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and…
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMay 6, 2026
Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1 recall — FDA Z-1771-2026
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the…
Class IFDA: OngoingBoston Scientific Corporation
Medical DeviceMay 6, 2026
Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker recall — FDA Z-1770-2026
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the…
Class IFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 18, 2026
Boston Scientific EndoVive Safety PEG Kit recall — FDA Z-1551-2026
Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the…
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceFeb 11, 2026
Boston Scientific HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm recall — FDA Z-1161-2026
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to…
Class IFDA: OngoingBoston Scientific Corporation
Medical DeviceFeb 11, 2026
Boston Scientific AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm recall — FDA Z-1158-2026
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to…
Class IFDA: OngoingBoston Scientific Corporation
Medical DeviceFeb 11, 2026
Boston Scientific *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm recall — FDA Z-1163-2026
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to…
Class IFDA: OngoingBoston Scientific Corporation
Medical DeviceFeb 11, 2026
Boston Scientific AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm recall — FDA Z-1159-2026
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to…
Class IFDA: OngoingBoston Scientific Corporation
Medical DeviceFeb 11, 2026
Boston Scientific *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm recall — FDA Z-1162-2026
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to…
Class IFDA: OngoingBoston Scientific Corporation
Medical DeviceFeb 11, 2026
Boston Scientific AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm recall — FDA Z-1160-2026
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to…
Class IFDA: OngoingBoston Scientific Corporation
Medical DeviceJan 21, 2026
Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm recall — FDA Z-1042-2026
Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the…
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceOct 22, 2025
Boston Scientific Model Number L211 PROPONENT DR SL MRI Pacemaker recall — FDA Z-0089-2026
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…
Class IFDA: OngoingBoston Scientific Corporation
Medical DeviceOct 22, 2025
Boston Scientific Model Number S702, ALTRUA 2 DR SL Pacemaker recall — FDA Z-0099-2026
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…
Class IFDA: OngoingBoston Scientific Corporation
Medical DeviceOct 22, 2025
Boston Scientific Model Number U128, VALITUDE CRT-P EL MRI recall — FDA Z-0102-2026
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…
Class IFDA: OngoingBoston Scientific Corporation
Medical DeviceOct 22, 2025
Boston Scientific Model Number L231, PROPONENT DR EL MRI Pacemaker recall — FDA Z-0091-2026
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…
Class IFDA: OngoingBoston Scientific Corporation
Understanding this recall history
This page summarizes recall records in which the official source identifies Boston Scientific Corporation as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.