FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is… — Class I medical device recall Z-0328-2017
Terminated recall by SentreHeart Inc, reported 2016-11-16, distributed in AZ, CA, CT, GA, IL, KS, MD, MI…. A complaint was received on September 27th, 2016 at a medical center in Germany for delamination and flaking o
| Recall number | Z-0328-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SentreHeart Inc, Redwood City, CA, United States |
| Recall initiated | 2016-09-29 |
| Classified | 2016-11-09 |
| Reported by FDA | 2016-11-16 |
| Terminated | 2017-03-01 |
| Distributed | AZ, CA, CT, GA, IL, KS, MD, MI, MO, NE, NH, NY, OR, PA, TX |
| Countries outside the US | DE, GB |
| Lot numbers | 01160568, 02160586, 07160639, 150 |
| Model numbers | 40-05 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0328-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.