Recall Z-2858-2011 ยท DQX Wire, Guide, Catheter
Terumo Medical Corporation
Runthrough NS Tapered PTCA Guidewire, item code number TW*DP418FH Product Usage The Runthrough NS guidewire is used to facilitate placement of balloon dilation catheters for Percutaneous Transluminal Coronary Angioplasty (PTCA) and/or Percutaneous Transluminal Angioplasty (PTA)
| Date | Jul 20, 2011 (initiated Jun 3, 2011) |
| Status | Terminated |
| Reason | Baloon catheter guidewires may become uncoiled during angioplasty procedures. |
| Root cause | Device Design |
| Action | Terumo Medical Corporation initiated contacting consignees on June 3, 2011 via an in-person visit to hand deliver an "URGENT PRODUCT BULLETIN: TERUMO PRODUCT SAFETY ALERT" letter dated June 3, 2011. The letter emphasized to consignees the importance of following the current instructions and recommendations provided to minimize the potential for damage during use and removal of the recalled product. For further questions, please contact your Terumo Territory Manager or call (800) 283-7866 and ask to speak with the Runthrough NS Guidewire Product Manager, at extension 4129. |
| Quantity | 70 units |
| Distribution | Nationwide (USA) Distribution -- including the states of: CT, GA, and SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063695 | RUNTHROUGH NS Terumo Medical Corp., Apr 27, 2007 |