Device product
HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545930
Z-0324-2022
Product summary
- Event
- Event 88991
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-0324-2022
Official wording
Reason: Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Code information: Batches: 25644951, 25649190, 25650286, 25651334, 25654287, 25947916, 25947918, 26010397, 26058298, 26406532, 26435581, 26449368, 26533973, 26555544, 26868194, 27074110, 27269956, 27384708. GTIN: 08714729283843 Exp. 05/27/2022 to 05/26/2023
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