Essentio Pacemaker Models Recalled for Potential Battery Depletion Risk
Boston Scientific is recalling six Essentio pacemaker models due to a hydrogen release defect that may compromise a critical capacitor and cause accelerated battery depletion. Approximately 31,548 units worldwide are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II recall involves no reported illnesses or injuries. The hazard is potential electrical compromise of a critical pacemaker component, which could impair the device's function over time. As a risk-of-harm scenario affecting a life-sustaining device with no actual adverse events reported, this warrants a High severity level.
Plain-English summary
Boston Scientific Corporation is recalling six models of the Essentio pacemaker: L100, L101, L110, L111, L121, and L131. The recall involves approximately 31,548 units with specific serial numbers that have been distributed worldwide.
The pacemakers are subject to a defect in which small amounts of hydrogen may be released inside the device. This hydrogen release can electrically compromise the low voltage capacitor, resulting in accelerated battery depletion and progression of battery depletion indicators. Affected devices may experience faster than normal battery drain.
Patients with implanted pacemakers from the affected models and serial numbers should contact Boston Scientific or their healthcare provider to determine if their device is involved in this recall.
The recalled product
- Product
- Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131
- Manufacturer
- Boston Scientific Corporation
- Hazard
- hydrogen-release
- battery-depletion
- capacitor-compromise
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)
- a) L100
- Serial Numbers: 464190
- 464192
- 464197
- 464199
- 464209
- 464211
- 464228
- 464229
- 464230
- 464238
- 464253
- 464258
- 464259
- 464279
- 464295
- 464296
- 464297
- 464308
- 464312
Distribution
Distribution scope not specified by the agency.
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