Recall record at a glance
| Official record | Z-1355-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Boston Scientific Corporation |
| Report date | Apr 8, 2015 |
| Recall initiation date | Feb 25, 2015 |
| Quantity | 289 |
| Location | Maple Grove, MN, United States |
Official product description
Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits
Why the product 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.
Distribution information
Worldwide Distribution - US Distribution to the states of : CA, WI, FL and OH., and to the countries of: Belgium, Czech Republic, Finland, France, Germany, Great Britain, Italy, Spain, Switzerland, Austria, Hungary, Netherlands and Portugal.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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