ESSENTIO DR Pacemakers May Malfunction Due to Battery Impedance Issue
Boston Scientific is recalling certain ESSENTIO DR Pacemakers manufactured before September 2018 due to latent battery impedance that may cause Safety Mode malfunction during normal operations.
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, the most serious FDA classification. Per the severity rubric, FDA Class I recalls must score at minimum 4 regardless of reported illnesses.
Plain-English summary
Boston Scientific Corporation has issued a recall of certain ESSENTIO DR Pacemaker models (L101, L111, L121, and L131) manufactured before September 2018. These devices contain latent high battery impedance that may cause them to initiate Safety Mode unexpectedly during normal operations such as telemetry or other higher-power functions, potentially affecting pacing therapy delivery.
The recall affects approximately 59,937 units in the United States, including Puerto Rico and the U.S. Virgin Islands, with an additional 96,792 units distributed internationally to Guam and the Northern Mariana Islands.
Patients should consult their healthcare provider regarding this recall. Healthcare providers can identify affected devices using the model numbers and serial numbers provided.
The recalled product
- Product
- ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Pacemaker
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 (3)
- L101 - UDI-DI: 00802526558924 and 00802526558931
- 00802526576317
- 00802526576812
Distribution
Part of a larger recall action
This product is one of 6 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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