Device product
Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Balloon Catheter is used endoscopically to 1) remove stones from the biliary system; or 2) to facilitate injection of contrast medium while occluding the duct with the balloon.
Z-0710-2014
Product summary
- Event
- Event 67139
- Status
- Terminated
- Classification
- Class II
- Quantity
- 39 units
- Official record key
device-enforcement:Z-0710-2014
Official wording
Reason: Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size
Code information: Lot Number:16231178
Distribution pattern: Worldwide Distribution - USA (Nationwide Distribution and Puerto Rico) and Internationally.
Derived failure modes
-
Unknown
Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size