Z-2858-2011

Runthrough NS Tapered PTCA Guidewire, item code number TW*DP418FH Product Usage The Runthrough NS guidewire...

Name: Z-2858-2011 Runthrough NS Tapered PTCA Guidewire, item code number TW*DP418FH Product Usage The Runthrough NS guidewire...
Creator: Terumo Medical Corporation
Published: 2011-06-03
License: https://open.fda.gov/license/

Terumo Medical Corp. / initiated 2011-06-03 / Terminated / root cause: design

FDA source

Terumo Medical Corporation began a recall of Runthrough NS Tapered PTCA Guidewire, item code number TW*DP418FH Product Usage The Runthrough NS guidewire is used to facilitate placement of balloon dilation... on 2011-06-03. The reason FDA records is "Baloon catheter guidewires may become uncoiled during angioplasty procedures". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2858-2011
Status: Terminated
Initiated: 2011-06-03
Posted: 2011-07-20
Terminated: 2011-07-27
Recalling firm: Terumo Medical Corp.
Product: 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)
Product code: DQX Wire, Guide, Catheter
Reason for recall: Baloon catheter guidewires may become uncoiled during angioplasty procedures.
Root cause tag: design
FDA 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 in commerce: 70 units
Distribution: Nationwide (USA) Distribution -- including the states of: CT, GA, and SC.
Product codes and lots: Lot 101028, exp 2013 - 09

Product code DQX

K063695Class IIRunthrough NsTerumo Medical Corp. / cleared 2007-04-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)