Reported Dec 8, 2021 · Ongoing
HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
- HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi
- UPNM00545890
- Lot codes and dates
- GTIN08714729283805
- Lot Numbers
25612668256498122570420825771760258785522600069526010387260582842608717226087173261231812632474226366746264065132642980826499853265273742657385326638827266517182666544826893604270269842707410927145234271623212725523527306699. Exp. 05/19/2022 to 05/13/2023
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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