Recall Z-2319-2015 ยท DQO Catheter, Intravascular, Diagnostic
Cook Inc.
Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.
| Date | Aug 5, 2015 (initiated Jul 2, 2015) |
| Status | Terminated |
| Reason | Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result. |
| Root cause | Component design/selection |
| Action | Cook Medical sent an Urgent Medical Device Recall letter dated July 2, 2015, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification and instructions for returning the affected product. All customers were notified via courier. Customers with questions were instructed to contact Cook Medical Customer Relations at (800) 457-4500 or (812) 339-2235. Firm issued press release 8/3/2015. |
| Quantity | 248167 |
| Distribution | Worldwide Distribution - US (nationwide including Puerto Rico and US Virgin Islands), Algeria, Antigua, Armenia, Austria, Australia, Bahamas, Belgium, Bangladesh, Bulgaria, Bahrain, Brazil, Brunei Darussalam, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122937 | SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX) Cook, Inc., Dec 14, 2012 |