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, PREGNANT
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
- GTIN 00802526576492, Serial numbers: 705372, GTIN 00802526559334, Serial numbers: 100002, 100003, 100004, 100005, 100007 +14 more
- 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 regulate heart rhythm. They are used in patients with bradycardia or heart rhythm disorders. The recall affects multiple Boston Scientific models intended for long-term rhythm management.
Why This Is Dangerous
The defect relates to software that enhances Safety Architecture. It could prevent initiating Safety Mode in an ambulatory setting when battery impedance is high, potentially compromising device safety features.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Affected patients may require medical evaluation, device monitoring, or replacement. The recall could disrupt ongoing rhythm-management therapy and necessitate clinical scheduling.
Practical Guidance
How to identify if yours is affected
- Compare your device identifiers to the GTINs and serial numbers listed in the recall notice: GTIN 00802526576492; GTIN 00802526559334; Serial numbers 705372, 100002, 100003-100021.
- Check your device label, packaging, or the patient ID card provided by your clinician for GTIN and serial numbers.
- Refer to the FDA enforcement page for the official list of affected devices.
Where to find product info
Identifiers are on device labeling and packaging. Serial numbers are usually recorded in the patient device record and recall communications.
What timeline to expect
Remedies and replacements may take weeks to months, depending on clinical needs and device availability.
If the manufacturer is unresponsive
- Escalate with your clinician and request a formal recall remediation plan.
- Contact FDA recall enforcement or your local regulator if you receive no action within an advised timeframe.
How to prevent similar issues
- Verify device status during routine device checks.
- Keep the recall letter and any communications for future reference.
- Discuss with your clinician about monitoring plans or replacement options,
Documentation advice
Keep the recall notification, device identifiers, clinician communications, and any replacement or monitoring documentation.
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Product Details
Product: Pacemaker; Brand: Boston Scientific; Model numbers/identifiers: S701 ALTRUA 2 SR SL Pacemaker; GTINs 00802526576492 and 00802526559334; Serial numbers 705372, 100002, 100003-100021; Distribution: Worldwide; Sold: Unknown; Price: Unknown; Quantity recalled: 4841 units.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Affects ACCOLADE family pacemakers and VISIONIST/VALITUDE CRT-Ps
- Hazard: software could prevent Safety Mode initiation due to high battery impedance
- Notification method: Letter
- No injuries or incidents have been reported
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Safety Guide
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