FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0328-2017
- 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.
- Status
- Terminated
- Initiated
- 2016-09-29
- Posted
- 2016-11-09
- Terminated
- 2017-03-01
- 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
- Lot, serial or model codes
- Lot# 01160568 . Lot#02160586, (no products shipped from this lot) Lot# 07160639 -150
- 510(k) numbers
- ["K080364"]
- PMA numbers
- not on file
- Product code
- DQX
- Firm FEI
- 3006482885
- Firm city
- Redwood City
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28