ESSENTIO extended life MRI pacemakers recalled for Safety Mode software update
Boston Scientific is recalling 190,088 ESSENTIO DR EL MRI 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 ESSENTIO DR EL MRI Pacemaker, model L131, 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 190,088 units carrying GTIN 00802526559266, 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
- Model Number L131, ESSENTIO DR EL MRI Pacemaker
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Pacemaker
- Affected units
- 190,088
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 00802526559266
- Serial Numbers: 102068
- 102071
- 102072
- 102074
- 102086
- 102089
- 102091
- 102092
- 102094
- 102095
- 102097
- 102101
- 102102
- 102104
- 102108
- 102115
- 102120
- 102122
- 102124
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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See all →- CriticalPacemakers recalled for software update preventing Safety Mode from battery impedance
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- CriticalACCOLADE dual chamber MRI pacemakers recalled for Safety Mode software update
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- CriticalACCOLADE dual chamber extended life MRI pacemakers recalled for software update
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