Boston Scientific Recalls ESSENTIO Pacemakers Due to Battery Depletion
Boston Scientific is recalling ESSENTIO pacemakers and CRT-P systems due to an elevated potential for early replacement caused by hydrogen-induced accelerated battery depletion.
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: The agency classification is Class II, and the hazard involves accelerated battery depletion in a life-sustaining medical device, which poses a significant risk of harm requiring early replacement.
Plain-English summary
Boston Scientific Corporation is recalling specific models of ESSENTIO pacemakers and CRT-P systems. The affected devices include the ESSENTIO SR (L100), ESSENTIO DR (L101), ESSENTIO MRI SR (L110), ESSENTIO MRI DR (L111), ESSENTIO EL DR (L121), and ESSENTIO MRI EL DR (L131) models.
The recall is being conducted because Boston Scientific identified a subset of these active systems with an elevated potential for early pacemaker replacement. This issue is attributed to hydrogen-induced accelerated battery depletion.
The affected devices were distributed in Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, and Wyoming. Patients with these devices should contact their healthcare provider for evaluation and potential replacement.
The recalled product
- Product
- ESSENTIO Pacemaker
- 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 (6)
- ESSENTIO SR model L100
- ESSENTIO DR model L101
- ESSENTIO MRI SR model L110
- ESSENTIO MRI DR model L111
- ESSENTIO EL DR model L121
- and ESSENTIO MRI EL DR model L131
Distribution
Part of a larger recall action
This product is one of 5 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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