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)
FDA Recall Z-2858-2011 · Posted 2011-07-20
Advertisement
Recalling FirmTerumo Medical Corporation
Recall StatusTerminated
Product CodeDQX
Date Initiated2011-06-03
Date Terminated2011-07-27
Product Quantity70 units
Reason for Recall
Baloon catheter guidewires may become uncoiled during angioplasty procedures.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Nationwide (USA) Distribution -- including the states of: CT, GA, and SC.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement