Reported Dec 8, 2021 · Ongoing
HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter…
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 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi
- UPNM00545960
- Lot codes and dates
- Batches
239 of 239 codes
256087612564011625640117256448342564981925649824256498292564983425678825256788302567883525678839256788802568056025704230257042312570423225739169257391702580671425819946258199472581994825836147258361482585047525850476258504772585047825850479258505402585054125878986258789872587898825878989258789902587899125930854259401282594012925940130259639792596916125969162259757882597578925975790259757912601039926010400260478952604789626047897260478982604789926048760260584322605917226123198
- GTIN08714729283874 Exp. 05/18/2022 to 06/03/2023
- Batches
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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Boston Scientific Corporation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.