HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545960
Reported: December 8, 2021 Initiated: October 21, 2021 #Z-0327-2022
Product Description
HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545960
Reason for Recall
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Details
- Recalling Firm
- Boston Scientific Corporation
- Distribution
- US Nationwide distribution.
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545960. Recalled by Boston Scientific Corporation.
Why was this product recalled? ▼
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 8, 2021. Severity: Moderate. Recall number: Z-0327-2022.
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