FDA Device recall Z-0328-2017
FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for introduction and posi…
- FDA Device
- Class I
- terminated
- Published 2016-11-16
On 2016-11-16 the FDA classified a Class I recall of FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for introduction and posi… by Sentreheart, citing 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 .02….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0328-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-09-29 |
| Published | 2016-11-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Sentreheart |
| Distribution | AZ, CA, CT, GA, IL, KS, MD, MI, MO, NE, NH, NY, OR, PA, TX |
Product
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.
Reason
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.
Identifiers
| code_info | Lot# 01160568 . Lot#02160586, (no products shipped from this lot) Lot# 07160639 -150 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0328-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.