Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
FDA Recall Z-1198-2019 · Posted None
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Recalling FirmCordis Corporation
Recall StatusTerminated
Product CodeDQY
Date Initiated2019-02-07
Date Terminated2021-11-03
Product Quantity23481
Reason for Recall
Frayed pieces of the mounting card being inside the primary packaging.
Firm Action
A letter and Acknowledgement Form will be sent overnight on February 07, 2019 to the direct consignees.
The letter provides instructions to our direct consignees to notify any additional consignees or departments as to the market action.
For health care professionals with medical concerns, please contact the Cordis Endovascular Medical Information Line 877-DEVICE5 (877-338-4235, Monday through Friday from 9:00 AM to 5:00 PM EST.
For questions related to the recall and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at:
[email protected] or call 1(800)292-9332
Root Cause
Equipment maintenance
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and Guam Singapore and Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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