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U.S. Department of Health and Human Services

Class 1 Device Recall Boston Scientific pacemaker

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 Class 1 Device Recall Boston Scientific pacemakersee related information
Date Initiated by FirmMarch 19, 2026
Date PostedApril 24, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1771-2026
Recall Event ID 98615
PMA NumberP030005 
Product Classification Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) - Product Code NKE
ProductBoston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL MRI, Model Number U128; 3. VISIONIST CRT-P EL, Model Number U225; 4. VISIONIST CRT-P EL, Model Number U226; 5. VISIONIST CRT-P EL MRI, Model Number U228.
Code Information The advisory population includes all models listed; however, the bounding differs by battery type: " All serialized DR-EL pacemakers and CRT-Ps from the ACCOLADE family are included in the advisory population. " ACCOLADE DR-SL and SR-SLs with a use-by-date (UBD) on or before 30 June 2025 are included in the advisory population. Model number alone will not precisely identify individual DR-SL or SR-SL devices in the advisory population. To determine if a device is affected, enter a model/serial into the device lookup tool at www.BostonScientific.com/lookup.
FEI Number 2124215
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
4100 Hamline Ave N
Saint Paul MN 55112-5700
For Additional Information ContactUnited States Technical Services
800-277-3422
Manufacturer Reason
for Recall		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 advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia
FDA Determined
Cause 2		Nonconforming Material/Component
ActionBoston Scientific issued an Urgent Medical Device Correction notice to physicians, hospitals, and patients on 3/19/2026 via Federal Express or USPS certified mail. The notice explained the availability of the updated software, Brady Software maintenance release 6 (SMR6) for the ACCOLADE family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps), clinical and device longevity of the update, and recommendations for recommendations on the upgrade. In a separate notice, patients were advised to keep and attend all scheduled medical and device check appointments and talk to their doctor about the best steps for managing their pacemaker system. To confirm if the pacemaker or CRT-P is affected, please visit this website: www.BostonScientific.com/lookup. The language, as well as the model and serial numbers of the device, are required for the lookup which can be found on your patient ID card. Our Product Performance Resource Center at www.bostonscientific.com/ppr, includes information on this topic, a device lookup tool, and instructions for returning explanted products. If you have additional questions, or would like to report on a clinical event, please contact your Boston Scientific representative or Technical Services.
Quantity in Commerce685,776 units
Distributionworldwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = NKE
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