FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for in
FDA device recall Z-0328-2017 · posted 2016-11-09 · Terminated
Recall details
- Recalling firm
- SentreHeart Inc
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- 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
- Date initiated
- 2016-09-29
- Date posted
- 2016-11-09
- Date terminated
- 2017-03-01
- Location
- Redwood City, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FINDRWIRZ GUIDE WIRE SYSTEM (K080364) | Sentreheart, Inc. | 2008-08-11 |