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)
This recall has been terminated (originally issued July 20, 2011).
- Company
- Terumo Medical Corporation
- Recall Initiated
- June 3, 2011
- Posted
- July 20, 2011
- Terminated
- July 27, 2011
- Recall Number
- Z-2858-2011
- Quantity
- 70 units
- Firm Location
- Elkton, MD
- Official Source
- View on FDA website ↗
Reason for Recall
Baloon catheter guidewires may become uncoiled during angioplasty procedures.
Distribution
Nationwide (USA) Distribution -- including the states of: CT, GA, and SC.
Lot / Code Info
Lot 101028, exp 2013 - 09
Root Cause
Device Design
Action Taken
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.