Z-0328-2017Class I

FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular...

Name: Z-0328-2017 FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular...
Creator: SentreHeart Inc
Published: 2016-09-29
License: https://open.fda.gov/license/

Sentreheart, Inc. / initiated 2016-09-29 / Terminated / root cause: packaging

FDA source

SentreHeart Inc began a recall of FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for introduction and positioning of over... on 2016-09-29. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0328-2017
Classification: Class I
Status: Terminated
Initiated: 2016-09-29
Posted: 2016-11-09
Terminated: 2017-03-01
Recalling firm: Sentreheart, Inc.
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.
Product code: DQX Wire, Guide, Catheter
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.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: SentreHeart sent an Urgent Medical Device Voluntary Recall letter dated September 29, 2016, to all affected customers by traceable delivery method. Letters explained the issue and requested that any devices from the two affected lots be returned to SentreHEART immediately. Customers were asked to complete and return the enclosed response form as soon as possible via fax at 650-354-1204 or email to [email protected]. Customers with questions were instructed to call 1-855-256-7330. For questions regarding this recall call 650-241-6008.
Quantity in commerce: 132 worldwide distribution (98) of those units in US
Distribution: 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
Product codes and lots: Lot# 01160568 . Lot#02160586, (no products shipped from this lot) Lot# 07160639 -150

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0328-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0328-2017	Class I	Terminated	Voluntary: Firm initiated	2016-11-16	2016-11-09

Product code DQX

K080364Class IIFindrwirz Guide Wire SystemSentreheart, Inc. / cleared 2008-08-11

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)