Boston Scientific Cardiac Pacemakers Require Software Update
Boston Scientific is expanding a software advisory for ACCOLADE family pacemakers and cardiac resynchronization therapy devices. Updated software (Brady SMR6) is now available to address identified issues.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall affecting implanted cardiac devices. Class I recalls indicate a reasonable probability that the product will cause serious adverse health consequences or death, meeting the rubric criterion for a Severe (score 4) classification.
Plain-English summary
Boston Scientific Corporation has expanded an advisory for the ACCOLADE family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps). The expanded advisory now includes all CRT-P and dual-chamber extended life (DR-EL) devices within this family. Updated software, Brady software maintenance release 6 (SMR6), is now available to address the identified issue.
The advisory population encompasses approximately 685,776 units distributed worldwide. Affected models include VALITUDE CRT-P EL (Model U125), VALITUDE CRT-P EL MRI (Model U128), VISIONIST CRT-P EL (Models U225 and U226), and VISIONIST CRT-P EL MRI (Model U228), as well as all serialized DR-EL pacemakers and CRT-Ps from the ACCOLADE family. Additionally, ACCOLADE DR-SL and SR-SL devices with a use-by-date on or before 30 June 2025 are included.
To determine if a specific device is affected, patients and clinicians should use the device lookup tool at www.BostonScientific.com/lookup by entering the device model number and serial number. Affected individuals should contact their healthcare provider or Boston Scientific for further guidance regarding the software update.
The recalled product
- Product
- Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL MRI, Model Number U128; 3. VISIONIST CRT-P EL, Model Number U225; 4. VISIONIST CRT-P EL, Model Number U226; 5. VISIONIST CRT-P EL MRI, Mod
- Manufacturer
- Boston Scientific Corporation
- Hazard
- device-software-defect
- cardiac-device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- The advisory population includes all models listed
- however
Distribution
Distribution scope not specified by the agency.