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
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
- L221 PROPONENT DR EL Pacemaker, ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL, ALTRUA 2 DR EL, VISIONIST, VALITUDE CRT-P
- 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
Pacemakers are implanted devices that help regulate heart rhythm. They are used in various cardiac conditions and are critical to daily activities for many patients.
Why This Is Dangerous
A software feature intended to enhance Safety Architecture could fail to initiate Safety Mode due to a high battery impedance state, potentially compromising device safety during ambulatory use.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Recalled devices could pose ongoing safety risks to patients; affected individuals should seek guidance from their clinicians and promptly follow recall instructions.
Practical Guidance
How to identify if yours is affected
- Identify if your device is part of the ACCOLADE family or VISIONIST/VALITUDE CRT-Ps
- Consult your clinician if your device matches any of the above
Where to find product info
Serial numbers and GTINs can be found on device labels, implantation records, or manufacturer documentation
What timeline to expect
Recall notification will be provided by letter. Follow-up instructions will come from the manufacturer and your clinician
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer
- Contact your healthcare provider for guidance
- Consider filing a complaint with the FDA if you believe the issue is not being addressed
How to prevent similar issues
- Keep all recall letters and device documentation in a safe place
- Regularly review device recall notices with your clinician
- Do not attempt to modify device software yourself
Documentation advice
Keep recall notices, device identifiers (GTIN, serial numbers), clinician communications, and any responses from the manufacturer or FDA.
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Product Details
Product: L221 PROPONENT DR EL Pacemaker. Brand: Boston Scientific. Affected devices include ACCOLADE family devices (ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL/EL) and VISIONIST and VALITUDE CRT-Ps. Quantity: 3592 units. Distribution: Worldwide. Sold through hospitals and clinics worldwide. Price: Unknown. When sold: Unknown. GTINs/Serials part of the recall include: GTIN 00802526578045; GTIN 00802526559129; GTIN 00802526576416. Serial Numbers: 723080, 723248, 725570, 729255, 732639, 100156, 100157, 100167, 100180, 100185, 100247, 100254, 100263, 100268, 100272, 100278, 100279, 100282, 100,
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Affects ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL/EL, VISIONIST, VALITUDE CRT-Ps
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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