Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits
Reported: April 8, 2015 Initiated: February 25, 2015 #Z-1355-2015
Product Description
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.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 289
- 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.
- Location
- Maple Grove, MN
Frequently Asked Questions
What product was recalled? ▼
Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits. Recalled by Boston Scientific Corporation. Units affected: 289.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 8, 2015. Severity: Moderate. Recall number: Z-1355-2015.
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