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
- Cardiac Pacemaker
- Model numbers
- GTIN 00802526559426, Serial 709683, Serial 709711, Serial 709737, Serial 709778, Serial 709780, Serial 709789, Serial 709792 +12 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 are implanted devices that regulate heart rhythm in patients with conduction abnormalities. They are critical for maintaining steady heart rates in many patients.
Why This Is Dangerous
The software intended to heighten Safety Architecture may fail to initiate Safety Mode when a high battery impedance state is present, potentially compromising device safety during ambulatory use.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
The recall targets devices used for life-sustaining rhythm management. Patients could require medical evaluation and potential device replacement or software updates under clinician supervision.
Practical Guidance
How to identify if yours is affected
- Check device model name and serial number printed on the device label or patient card.
- Compare against the recalled GTIN and serial numbers list included in the recall notice.
- Verify whether your device is ACCOLADE family or VISIONIST/VALITUDE CRT-P.
Where to find product info
Identify numbers on the device label, patient records, and the recall notice provided by the manufacturer.
What timeline to expect
Replacement or software update timelines vary; expect several weeks to months depending on clinical scheduling.
If the manufacturer is unresponsive
- Notify your clinician or hospital’s device program.
- If you cannot reach your clinician, contact Boston Scientific through official recall channels or file a patient safety complaint with the FDA.
How to prevent similar issues
- Maintain up-to-date patient records showing device identifiers.
- Do not alter device settings without clinician guidance.
- Stay in close contact with your care team for updates on the recall process.
Documentation advice
Keep the recall letter, device label, serial numbers, and all communications with clinicians and the manufacturer for records.
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Product Details
Device families affected include ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual-chamber pacemakers (standard life SL and extended life EL) as well as VISIONIST and VALITUDE CRT-P devices. Model Number U225 VISIONIST CRT-P EL. GTIN 00802526559426. Serial numbers include 709683, 709711, 709737, 709778, 709780, 709789, 709792, 709794, 709804, 709815, 709816, 709827, 709828, 709829, 709830, 709831, 709889, 709907, 709912. Quantity: 12,326 units. Distribution: Worldwide. When sold: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- ACCOLADE family devices and VISIONIST/VALITUDE CRT-Ps affected
- High-risk Class I recall
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Safety Guide
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