FDAFDA · Food and drugs·Recall number Z-0620-2016
Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary
Published January 20, 2016 · Recall initiated: December 10, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- International Distribution to countries of: COLOMBIA, JAMAICA, TRINIDAD & TOBAGO.
- Lot
- Serial numbers 702961, 702963, 705644, 705666, and 705947.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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