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Recall Observatory FDA recall evidence

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

October 21, 2021

Class II

Product summary

Firm
Boston Scientific Corporation
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

    reason.no_named_rule · v1.0.0

    Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure