Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L111. These pulse gener
FDA device recall Z-2749-2016 · posted 2016-09-07 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Five Accolate MRI and Essentio MRI DR pulse generators with an alternate MICS module configuration were shipped to US customers and implanted. This alternate configuration did not receive FDA approval yet.
- Action taken
- As we considered the value of a direct physician communication we have not identified any information that would be of value to the physician because device performance and behavior remain unchanged.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LWP
- Quantity affected
- 5
- Distribution
- Distributed to the states of TX, NH, MA, PA, and MN.
- Date initiated
- 2016-06-15
- Date posted
- 2016-09-07
- Date terminated
- 2017-02-06
- Location
- Saint Paul, MN
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