Boston Scientific Pacemakers Subject to Software Update Advisory
Boston Scientific is issuing a software update (Brady SMR6) for certain ACCOLADE and PROPONENT pacemakers and cardiac resynchronization therapy devices. The advisory population is expanding to include all dual-chamber extended life and CRT-P devices.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as Class I, which per the rubric mandates a minimum score of 4. Class I recalls involve devices that may cause serious injury or death. Although no specific illnesses or injuries are reported in the source text, the Class I designation and the critical nature of pacemakers as life-sustaining devices justify a Severe rating.
Plain-English summary
Boston Scientific Corporation has made available updated software, Brady software maintenance release 6 (SMR6), for the ACCOLADE family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps). The advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices.
Affected devices include multiple pacemaker models: ESSENTIO SR SL (L100), ESSENTIO DR SL (L101), ESSENTIO SR SL MRI (L110), ESSENTIO DR SL MRI (L111), ESSENTIO DR EL (L121), ESSENTIO DR EL MRI (L131), PROPONENT SR SL (L200), PROPONENT DR SL (L201), PROPONENT DR (VDD) SL (L209), PROPONENT SR SL (L210), PROPONENT DR SL MRI (L211), PROPONENT DR EL (L221), PROPONENT DR EL MRI (L231), ACCOLADE SR SL (L300), ACCOLADE DR SL (L301), ACCOLADE SR SL MRI (L310), ACCOLADE DR SL MRI (L311), ACCOLADE DR EL (L321), ACCOLADE DR EL MRI (L331), ALTRUA 2 SR SL (S701), ALTRUA 2 DR SL (S702), and ALTRUA 2 DR EL (S722). These devices have been distributed worldwide.
Patients with affected devices should consult their healthcare provider or use the device lookup tool at www.BostonScientific.com/lookup to determine whether their specific device is included in the advisory population. The updated software addresses the affected devices used for treatment of conduction disorders requiring restoration of AV synchrony, VVI intolerance in the presence of persistent sinus rhythm, and low cardiac output or congestive heart failure secondary to bradycardia.
The recalled product
- Product
- Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as: 1. ESSENTIO SR SL, Model Number L100; 2. ESSENTIO DR SL Pacemaker, Model Number L101; 3. ESSENTIO SR SL MRI Pacemaker, Model Number L110; 4.…
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 718,456
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.
Part of a larger recall action
This product is one of 2 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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