Lower risk Medical device recall · FDA · Published March 19, 2026

Boston Scientific CRT-P Pacemakers: Software Update Needed for Safety

Boston Scientific recalls specific CRT-P pacemakers with outdated software. Updated software (SMR6) is available to prevent potential risks in heart conditions. Affected devices include VALITUDE and VISIONIST models with certain model numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1771-2026Medical device Boston Scientific ›

Lower-risk 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

Take action

Contact the company

Official pagewww.BostonScientific.com/lookup

Recalling firmBoston Scientific Corporation4100 Hamline Ave N · Saint Paul, MN 55112-5700

✎ GovInfoNow plain-language explainer

Boston Scientific is recalling specific cardiac pacemakers (VALITUDE and VISIONIST CRT-P EL models) because outdated software could pose risks for patients with certain heart conditions. This recall requires updating the software to prevent potential complications. Read more at govinfonow.com/recall/49657-boston-scientific-crt-p-pacemakers-software-update-needed-for-safety.

Source Summary by GovInfoNow · govinfonow.com/recall/49657-boston-scientific-crt-p-pacemakers-software-update-needed-for-safety · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1771-2026

Cite this page

“Boston Scientific CRT-P Pacemakers: Software Update Needed for Safety.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49657-boston-scientific-crt-p-pacemakers-software-update-needed-for-safety. Based on FDA recall #Z-1771-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1771-2026%22&limit=1).

The FDA announced on March 19, 2026, that Boston Scientific Corporation is recalling its Cardiac Resynchronization Therapy devices due to a software issue. The agency classified the recall as Class I.

How to tell if you have it

VALITUDE CRT-P EL, Model Number U125
VALITUDE CRT-P EL MRI, Model Number U128
VISIONIST CRT-P EL, Model Number U225
VISIONIST CRT-P EL, Model Number U226
VISIONIST CRT-P EL MRI, Model Number U228

The hazard

The recall involves updated Brady software maintenance release 6 (SMR6) for the ACCOLADE family of pacemakers and cardiac resynchronization therapy pacemakers. The advisory population now includes all CRT-P and dual-chamber extended life devices.

Context

GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Recent recalls include the Imager II Angiographic Catheters Recall from August 24, 2026, and the LUX-Dx Cardiac Monitor System Recall from August 6, 2026. Other recent recalls of similar products include the Philips Cardiac Workstation 7000 (July 1, 2026), the Philips Cardiac Workstation 5000 (July 1, 2026), and the Abbott Medical Merlin PCS 365 (May 12, 2026).

How to tell if you have this one

Check if your pacemaker is labeled as VALITUDE CRT-P EL (Model U125), VALITUDE CRT-P EL MRI (Model U128), VISIONIST CRT-P EL (Model U225 or U226), or VISIONIST CRT-P EL MRI (Model U228). Use the device lookup tool at www.BostonScientific.com/lookup to confirm if your specific model is affected.

Brand
Boston Scientific
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Ongoing
Distribution
worldwide

Recall number	Product, codes & lots	Quantity
Z-1770-2026	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.; 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.	718,456 units
Z-1771-2026	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.; 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.	685,776 units

Based on the official FDA remedy

What to do — step by step

Check Device Status
Visit www.BostonScientific.com/lookup and enter your model or serial number to see if your device is affected.

How this recall unfolded

Recall timeline

FDA published this recall 48 days after the firm started it.

Mar 19, 2026Firm started the recall
Apr 24, 2026FDA classified it Class I
May 6, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Take action

Contact Boston Scientific

We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.

✉️ Open in emailCompany site

Subject: Recall Z-1771-2026 — Boston Scientific CRT-P Pacemakers: Software Update Needed for Safety

Hello,

I own a Boston Scientific CRT-P Pacemakers: Software Update Needed for Safety that is covered by recall Z-1771-2026 from Boston Scientific.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Link to this recall

<a href="https://govinfonow.com/recall/49657-boston-scientific-crt-p-pacemakers-software-update-needed-for-safety">Boston Scientific CRT-P Pacemakers: Software Update Needed for Safety (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1771-2026 (March 19, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1771-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.