Device product
HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910
Z-0322-2022
Product summary
- Event
- Event 88991
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-0322-2022
Official wording
Reason: Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Code information: GTIN: 8714729283829 Batches: 25623385, 25678822, 25739151, 25771772, 25975774, 26010392, 26051928, 26087733, 26123186, 26175469, 26406521, 26429810, 26456904, 26579839, 26581406, 26601326, 26660957, 26793786, 26896864, 27026985, 27096335, 27226570, 27255234, 27400203. Exp. 05/23/2022 to 05/28/2023
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