Z-1771-2026Class I

Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125...

Name: Z-1771-2026 Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125...
Creator: Boston Scientific Corporation
Published: 2026-03-19
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2026-03-19 / Open, Classified / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of 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... on 2026-03-19. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1771-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-03-19
Posted: 2026-04-24
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.
Product code: NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
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
Root cause tag: manufacturing process
FDA 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 in commerce: 685,776 units
Distribution: worldwide
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1771-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1770-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-24
Z-1771-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-24

Product code NKE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)