Device product
Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above UPN: M00547300
Z-2673-2017
Product summary
- Event
- Event 77431
- Status
- Terminated
- Classification
- Class II
- Quantity
- 39 units
- Official record key
device-enforcement:Z-2673-2017
Official wording
Reason: Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon
Code information: Lot Number: 19343203 Exp.: 6/30/2018
Distribution pattern: MI, MO Foreign: Austria France Great Britain Italy Spain Sweden
Derived failure modes
-
Unknown
Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon