Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit, E
FDA device recall Z-1336-2015 · posted 2015-03-27 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Boston Scientific is initiating this Medical Device Field Correction of the Expel" APD and APDL Drainage Catheters. To date, Boston Scientific has received one complaint for device fragmentation after an Expel" APD catheter was implanted in the biliary system. The most serious foreseeable patient risk for this issue is additional intervention for fragment retrieval using minimally invasive meth
- Action taken
- Boston Scientific sent an "Urgent Medical Device Correction" letter dated February 25, 2015, to all affected customers. The letter described the problem and the product involved in the recall. The letter informed customers not to use the Expel APD and APDL Drainage catheters for bile drainage and to complete and return the Customer Acknowledgement Form. The letter also noted that the devices are not being retrieved and they are not required to return them to Boston Scientific. For further questions please call (763) 494-7971.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 918
- Distribution
- Worldwide Distribution - US Distribution to the states of : CA, LA, FL, WI, NY, IL, MD and OH., and to the countries of: Belgium, Czech Republic, Finland, France, Germany, Great Britain, Italy, Spain,
- Date initiated
- 2015-02-25
- Date posted
- 2015-03-27
- Date terminated
- 2016-08-12
- Location
- Maple Grove, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXPEL APD DRAINAGE CATHETER SYSTEM (K141335) | Boston Scientific Corp | 2014-10-17 |