Boston Scientific Corporation: Boston 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.

Recall number

Z-1771-2026

Recalling firm

Boston Scientific Corporation

Product

Boston 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.

Status

Open, Classified

Initiated

2026-03-19

Posted

2026-04-24

Terminated

not on file

Reason

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

Root cause

Nonconforming Material/Component

Action

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.

Quantity

685,776 units

Distribution

worldwide

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

P030005

Product code

NKE

Firm FEI

2124215

Firm city

Saint Paul

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy