Boston Scientific Corporation Recall: Various Lots of Expel Drainage Catheter with TwistLo
Boston Scientific Corporation Recall: Various Lots of Expel Drainage Catheter with TwistLo is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Boston Scientific Corporation; Product: Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Ca
| Recalling firm | Boston Scientific Corporation |
|---|---|
| Product | Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits |
| Reason for recall | 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | 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. |
| Recall initiated | 20150225 |
| Recall number | Z-1355-2015 |
| Category | device |
| State | MN |
| Country | United States |
$29/mo
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