Boston Scientific recall
Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as…
Why was Boston Scientific recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial numbers 702961, 702963, 705644, 705666, and 705947.
- Product
- Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as…
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 5
- Distribution
- International Distribution to countries of: COLOMBIA, JAMAICA, TRINIDAD & TOBAGO.
- Recall date
- January 20, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)