Tuesday, 17 January 2017 13:41

Recall Of FindrWIRZ Guidewire System by SentreHeart

The Agency is notifying you that SentreHeart is recalling FindrWIRZ Guidewire System because the polytetrafluoroethylene (PTFE) coating may separate from the wire and potentially cause serious injuries to patients. Coating separation may be caused by issues with device design or manufacturing processes.

The FindrWIRZ Guidewire system is intended for use during minimally invasive procedures in the cerebrovascular, cardiovascular and peripheral vascular systems to help position over-the-wire catheters through the insertion of a thin flexible tube into arteries of the leg or wrist. The device has a hydrophilic lubricious PTFE coating, designed to reduce friction between the device and the blood vessels.

Reasons for Recall

The company initiated the recall because the PTFE coating may separate from the wire.

Possible Associated Risks

Small pieces of the coating could break away and travel elsewhere in the body, or the exposed wire beneath the coating could cause serious blood clots in the patient’s bloodstream. Both circumstances could lead to serious adverse health consequences, including embolism, stroke or death.

Recalled Product Details

A total of 98 units are affected by the recall, with lot numbers 01160568, 02160586 and 07160639-150, manufactured between January 4, 2016 and July 22, 2016 and distributed between June 1, 2016 and September 26, 2016.

Healthcare Provider’s Action

  • Identify and discontinue the use of affected products.
  • Healthcare providers and patients are encouraged to report adverse events associated with the use of these products to the nearest NAFDAC office, NARDAC PRASCOR (20543 TOLL FREE from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

NAFDAC........Safeguarding the Health of the Nation!!!

Read 2604 times Last modified on Tuesday, 17 January 2017 13:43



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