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.
Reported: March 23, 2016 Initiated: December 31, 2015 #Z-1174-2016
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).
Details
- Recalling Firm
- Cordis Corporation
- Units Affected
- 1,985 units
- Distribution
- US Nationwide Distribution including states of:AL, AZ, CA, CO, CT, FL, GA, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ,NY, OH, OR, PA, RI, TN, TX, VA, WA, WV, and Hawaii.
- Location
- Miami Lakes, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Cordis Corporation. Units affected: 1,985 units.
Why was this product recalled? ▼
Incorrect cannula of the sheath introducer (smaller than intended).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 23, 2016. Severity: Moderate. Recall number: Z-1174-2016.
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