Reported Apr 8, 2015 · Terminated
Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits
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 · 1 Scimed Pl · Maple Grove, MN · 55311-1565
Is this the product you have?
- Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits
- Lot codes and dates
- UPN # LOT # H7493933108200 17245003, 17416605, 17489192 H7493933108350 17245004, 17245005, 17370709, 17408756 H749393310835K1 17411333, 17493554 H7493933110200 17318047 H7493933110350 17275822, 17438003, 17494025, 17501572 H749393311035K1 17328808, 17403871, 17416578, 17459144 H7493933110400 17275824, 17416608 H7493933112350 17245006, 17259580, 17275819 H7493933114350 17275815, 17338207 with Expiration Dates between January 30, 2016 and May 8, 2016
- Amount recalled
- 289
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Complaints of device fragmentation after the catheter was implanted in the biliary system. The most serious patient risk for this issue is additional intervention for fragment retrieval using minimally invasive methods and, in some of the reported cases, this was performed to retrieve the device fragments.
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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