Recall Z-0885-2011 ยท DQY Catheter, Percutaneous
Boston Scientific Corporation
Boston Scientific Guider Softip TM XF Guide Catheter Catheter is intended to facilitate the placement of interventional devices into the neurovascular system.
| Date | Jan 7, 2011 (initiated Dec 18, 2009) |
| Status | Terminated |
| Reason | Complaint about product quality: degradation of polymer portion of the distal section of the catheter. |
| Root cause | Other |
| Action | Boston Scientific sent an Urgent Medical Device Recall and Correction letter dated December 18, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product and fill out the Customer Instructions and REPLY VERIFICATION TRACKING FORM indicating the status of the affected product and send a copy of the form by fax to 510-624-1600 or e-mail to Joe.Nesci@beci.com. |
| Quantity | 94,296 units |
| Distribution | Worldwide. US Domestic including US Federal Government, and foreign countries. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.