FDA Enforcement
Class II
Ongoing
HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545930
Recall: Z-0324-2022
·
Reported December 8, 2021
Enforcement
- Recall Number
- Z-0324-2022
- Event ID
- 88991
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Boston Scientific Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- December 8, 2021
- Initiation Date
- October 21, 2021
- Classification Date
- December 1, 2021
- Address
- 100 Boston Scientific Way, Marlborough, MA, 01752-1234, United States
Description
HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545930
Reason
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Code Info
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
US Nationwide distribution.