Recall Z-0328-2017— SentreHeart Inc
Class I · Terminated
Class I FDA medical device recall by SentreHeart Inc, initiated 2016-09-29, terminated 2017-03-01. It names one FDA 510(k) clearance: K080364. 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.. 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..
- Recalling firm
- SentreHeart Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2016-09-29
- Terminated
- 2017-03-01
- Firm location
- Redwood City, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.