Quick Facts at a Glance
- Recall Date
- August 20, 2025
- Hazard Level
- HIGH
- Brand
- Boston Scientific
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- Model numbers
- PROPONENT SR SL (Model L200), ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR, Visionist, Valitude
- Sold at
- Unknown
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
These pacemakers provide cardiac rhythm management for patients with arrhythmias. They are implanted devices that regulate heartbeats through electrical impulses.
Why This Is Dangerous
A software improvement intended to bolster Safety Architecture may inadvertently prevent Safety Mode activation when a high battery impedance state occurs, potentially compromising device safety.
Industry Context
This recall is not described as part of a broader pattern in the provided data.
Real-World Impact
The recall affects a small population of device patients worldwide. The immediate safety action is to stop using the product per manufacturer guidance, with a focus on medical supervision.
Practical Guidance
How to identify if yours is affected
- Check device model against ACCOLADE family and VISIONIST/VALITUDE CRT-P lists
- Verify with your electronic health record or device labeling
Where to find product info
Review device label and patient documentation supplied with the implant; check FDA recall page linked to enforcement report Z-0085-2026
What timeline to expect
Remedial actions and replacements will be communicated by the manufacturer; timelines vary by device and clinical needs
If the manufacturer is unresponsive
- Contact patient services at Boston Scientific
- Consult your healthcare provider
- File any required complaints with the hospital risk management
How to prevent similar issues
- Verify device firmware updates during routine follow-up
- Ask clinicians about risk mitigation for battery impedance states
- Ensure recall notifications are acknowledged and documented
Documentation advice
Keep the recall letter, device serials, GTINs, and all correspondence with Boston Scientific and healthcare providers
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Product Details
Model: PROPONENT SR SL (Model L200). Classification: Class I recall. Quantity: 1,380 units. Distribution: Worldwide. Brands involved: Boston Scientific. Devices involved in ACCOLADE family including ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL and EL, and VISIONIST and VALITUDE CRT-Ps. GTINs and serial numbers listed include GTIN 00802526559020 with serials 722605, 722614, 722634, 722647; GTIN 00802526576362 with serials 464359, 464382, 464387, 464444, 464447, 464457, 464462, 464471, 464505, 464511, 464514, 464517, 464521, 464525, 464527.
Reported Incidents
No incidents or injuries are documented in the provided data.
Key Facts
- 1,380 units recalled worldwide
- Involves ACCOLADE family plus VISIONIST and VALITUDE CRT-Ps
- High battery impedance state linked to software for Safety Architecture
- Class I recall
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Safety Guide
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