Recall Z-0328-2017 ยท DQX Wire, Guide, Catheter
SentreHeart Inc
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.
| Date | Nov 9, 2016 (initiated Sep 29, 2016) |
| Status | Terminated |
| 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. |
| 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 customerservice@sentreheart.com. Customers with questions were instructed to call 1-855-256-7330. For questions regarding this recall call 650-241-6008. |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080364 | FINDRWIRZ GUIDE WIRE SYSTEM Sentreheart, Inc., Aug 11, 2008 |