Recall Z-1174-2016— Cordis Corporation
Class II · Terminated
Class II FDA medical device recall by Cordis Corporation, initiated 2015-12-31, terminated 2016-08-25. It names one FDA 510(k) clearance: K970392. Product: CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intravascular device. A vessel dilator facilitates the percutaneous entry of the CSI by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel.. Reason: Incorrect cannula of the sheath introducer (smaller than intended)..
- Recalling firm
- Cordis Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-31
- Terminated
- 2016-08-25
- Firm location
- Miami Lakes, FL, 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
CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intravascular device. A vessel dilator facilitates the percutaneous entry of the CSI by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel.
Reason for recall
Incorrect cannula of the sheath introducer (smaller than intended).
Data sourced from openFDA. This site is unofficial and independent of the FDA.