Recalls / —
—#148506
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.
- FDA product code
- LWP — Implantable Pulse Generator, Pacemaker (Non-Crt)
- Device class
- Class 3
- Medical specialty
- Unknown
- PMA numbers
- P150012
- Affected lot / code info
- serial numbers 215173, 215186, 215507, 215855, 215957, 216051, 218956, 710312, and 710541.
Why it was recalled
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.
Root cause (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Boston Scientific Corporation
- Address
- 4100 Hamline Ave N, Saint Paul, Minnesota 55112-5700
Distribution
- Distribution pattern
- Distributed to the states of TX, NH, MA, PA, and MN.
Timeline
- Recall initiated
- 2016-06-15
- Posted by FDA
- 2016-09-07
- Terminated
- 2017-02-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #148506. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.