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Boston Scientific Pacemaker, Implantable Pulse Generator… recallZ-1770-2026 · Boston Scientific Corporation · initiated Mar 19, 2026

Class I Open, Classified All recalls posted in April 2026

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Nonconforming Material/Component

What the company is doing

Boston 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.

Recall details

Recall number
Z-1770-2026
Recall class
Class I (most serious)
Status
Open, Classified
Initiated by the company
Mar 19, 2026
Posted by the FDA
Apr 24, 2026
Recalling firm
Boston Scientific Corporation
Quantity
718,456 units
Product code
LWP
FDA submissions
P150012
Distribution
worldwide

Product description

Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as: 1. ESSENTIO SR SL, Model Number L100; 2. ESSENTIO DR SL Pacemaker, Model Number L101; 3. ESSENTIO SR SL MRI Pacemaker, Model Number L110; 4. ESSENTIO DR SL MRI Pacemaker, Model Number L111; 5. ESSENTIO DR EL Pacemaker, Model Number L121; 6. ESSENTIO DR EL MRI Pacemaker, Model Number L131; 7. PROPONENT SR SL Pacemaker, Model Number L200; 8. PROPONENT DR SL Pacemaker, Model Number L201; 9. PROPONENT DR (VDD) SL Pacemaker, Model Number L209; 10. PROPONENT SR SL Pacemaker, Model Number L210; 11. PROPONENT DR SL MRI Pacemaker, Model Number L211; 12. PROPONENT DR EL Pacemaker, Model Number L221; 13. PROPONENT DR EL MRI Pacemaker, Model Number L231*; 14. ACCOLADE SR SL Pacemaker, Model Number L300; 15. ACCOLADE DR SL Pacemaker, Model Number L301; 16. ACCOLADE SR SL MRI Pacemaker, Model Number L310; 17. ACCOLADE DR SL MRI Pacemaker, Model Number L311; 18. ACCOLADE DR EL Pacemaker, Model Number L321; 19. ACCOLADE DR EL MRI Pacemaker, Model Number L331*; 20. ALTRUA 2 SR SL Pacemaker, Model Number S701; 21. ALTRUA 2 DR SL Pacemaker, Model Number S702; 22. ALTRUA 2 DR EL Pacemaker, Model Number S722.

Code information (models, lots, serial numbers)

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.

Other devices under the same FDA submission

16 devices cleared under P150012 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 98615).

Sources and updates

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