Device product
HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545950
Z-0326-2022
Product summary
- Event
- Event 88991
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-0326-2022
Official wording
Reason: Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Code information: Batches: 25571372, 25673064, 25836146, 26010398, 26058426, 26123197, 26175501, 26216321, 26473779, 26759413, 26784680, 26848732, 26946145, 27121592, 27340635, 27393787 GTIN: 08714729283867 Exp. 05/09/2022 to 05/27/2023
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure