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.
FDA Recall Z-0328-2017 · Posted 2016-11-09
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Recalling FirmSentreHeart Inc
Recall StatusTerminated
Product CodeDQX
Date Initiated2016-09-29
Date Terminated2017-03-01
Product Quantity132 worldwide distribution (98) of those units in US
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.
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.
Root Cause
Under Investigation by firm
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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