PROPONENT single chamber standard life pacemakers recalled for software update
Boston Scientific is recalling 1,380 PROPONENT SR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.
Plain-English summary
The PROPONENT SR SL pacemaker, model L200, is covered by a recall in which software to enhance Safety Architecture is made available.
The software is designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state. It applies to the ACCOLADE family of devices, which includes ACCOLADE, PROPONENT, ESSENTIO and ALTRUA 2 dual chamber standard life and extended life pacemakers, and to VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers.
The recall covers 1,380 units carrying GTINs 00802526559020 and 00802526576362, distributed worldwide. The FDA has classified the recall as Class I.
Patients and clinicians should follow Boston Scientific's instructions for obtaining the software update at a device follow-up appointment.
The recalled product
- Product
- PROPONENT SR SL (Model L200)
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Pacemaker
- Affected units
- 1,380
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 (20)
- GTIN 00802526559020
- Serial numbers: 722605
- 722614
- 722634
- 722647. GTIN 00802526576362
- Serial numbers: 464359
- 464382
- 464387
- 464444
- 464447
- 464457
- 464462
- 464471
- 464505
- 464511
- 464514
- 464517
- 464521
- 464525
- 464527
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 27 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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