Boston Scientific Recalls Five Unapproved MRI Pacemakers
Boston Scientific is recalling five implanted pacemakers that used an unapproved module configuration. The devices were shipped to customers in five states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a risk-of-harm product (implanted pacemaker) where the specific hazard is the use of an unapproved configuration, and no injuries or illnesses have been reported in the source text.
Plain-English summary
Boston Scientific Corporation is recalling five implanted pulse generators: Accolade MRI DR Model L311, Accolade MRI DR EL Model L331, and Essentio MRI DR Model L111. These devices provide bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias.
The recall is due to the use of an alternate MICS module configuration that did not receive FDA approval. The affected units were shipped to US customers and implanted. The devices were distributed to the states of Texas, New Hampshire, Massachusetts, Pennsylvania, and Minnesota.
Affected serial numbers include 215173, 215186, 215507, 215855, 215957, 216051, 218956, 710312, and 710541. Patients with these specific devices should contact their healthcare provider for evaluation.
The recalled product
- Product
- Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L111. These pulse generators provide bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias.
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Pacemakers
- Hazard
- Affected units
- 5
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 (9)
- serial numbers 215173
- 215186
- 215507
- 215855
- 215957
- 216051
- 218956
- 710312
- and 710541.
Distribution
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