Quick Facts at a Glance
- Recall Date
- August 20, 2025
- Hazard Level
- HIGH
- Brand
- Boston Scientific
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- At-Risk Groups
- GENERAL, ELDERLY
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Boston Scientific
- Product type
- Pacemaker and CRT-P devices
- Model numbers
- U128, 100187, 100217, 100222, 100236, 100251, 100253, 100260 +13 more
- Sold at
- Multiple Retailers
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 20, 2025
Reported by FDA DEVICE
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Corporation or your healthcare provider for instructions. Notification method: Letter
About This Product
Pacemakers with CRT-P capability regulate heart rhythm for patients with heart failure or arrhythmias. They are implanted devices that provide ongoing therapy.
Why This Is Dangerous
A software flaw could prevent initiation of Safety Mode in an ambulatory setting when battery impedance is high, potentially compromising device safety responses.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Recipients must follow recall instructions. Immediate action may affect ongoing therapy and follow-up routines.
Practical Guidance
How to identify if yours is affected
- Confirm device is ACCOLADE family, VISIONIST or VALITUDE CRT-P with model U128 or listed numbers
- Review recall letter from Boston Scientific
- Check your device model against the published list
Where to find product info
FDA enforcement page; Boston Scientific recall notice
What timeline to expect
Remedy timing varies; follow recall letter and clinician guidance
If the manufacturer is unresponsive
- Contact your healthcare provider for guidance
- File a complaint with FDA MedWatch if the company is slow to respond
- Consult hospital patient advocacy if needed
How to prevent similar issues
- In future purchases, verify firmware and safety architecture controls in implanted devices
- Keep recall documentation accessible
- Schedule regular device checks with your cardiologist
Documentation advice
Retain recall notice, clinician instructions, and all correspondence; maintain a log of calls and dates
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Brand: Boston Scientific. Recall affects ACCOLADE family pacemakers and VISIONIST VALITUDE CRT-P devices. Model numbers include U128 and the following: 100187, 100217, 100222, 100236, 100251, 100253, 100260, 100262, 100274, 100275, 100277, 100289, 100317, 100328, 100330, 100350, 100359, 100361, 100363. GTIN: 00802526559402. Distribution: Worldwide. Recall date: 2025-08-20. Quantity: 28,911 units. Sold from unknown date; units distributed worldwide.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- ACCOLADE family pacemakers and VISIONIST VALITUDE CRT-P devices
- Model U128 and listed model numbers included in recall
- Notification by letter
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.