SentreHeart Inc: Medical Device Recall in 2016 - (Recall #: Z-0328-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for introduction and positioning of over the-wire catheters and therapeutic devices during interventional procedures.

Product Classification:

Class I

Date Initiated: September 29, 2016

Date Posted: November 16, 2016

Recall Number: Z-0328-2017

Event ID: 75395

Reason for Recall:

A complaint was received on September 27th, 2016 at a medical center in Germany for delamination and flaking of the PTFE lubricious coating on three FindrWIRZ Guidewire System .025 guidewires removed from their packaging hoops.

Status: Terminated

Product Quantity: 132 worldwide distribution (98) of those units in US

Code Information:

Lot# 01160568 . Lot#02160586, (no products shipped from this lot) Lot# 07160639 -150

Distribution Pattern:

Worldwide Distribution - US including MO, CA, OR, GA. NH, NY, MI, TX, MD, PA, IL, KS, NE, CT, AZ and Internationally to United Kingdom and Germany

Voluntary or Mandated:

Voluntary: Firm initiated