ACCOLADE dual chamber standard life pacemakers recalled for software update
Boston Scientific is recalling 32,695 ACCOLADE DR SL pacemakers, part of a software update designed to prevent Safety Mode starting outside hospital because of a high battery impedance state.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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 ACCOLADE DR SL pacemaker, model L301, 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 32,695 units carrying GTIN 00802526558924, 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
- ACCOLADE DR SL (Model L301)
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Pacemaker
- Hazard
- software-update
- battery-impedance
- safety-mode
- implantable
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 00802526558924
- Serial Numbers: 100056
- 100092
- 100111
- 100120
- 100122
- 100125
- 100127
- 100134
- 100136
- 100137
- 100142
- 100144
- 100147
- 100154
- 100156
- 100160
- 100161
- 100162
- 100168
Distribution
Distribution scope not specified by the agency.
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