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Recall Observatory FDA recall evidence

Device product

Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

Z-2079-2021

June 09, 2021

Class II

Product summary

Firm
Cordis Corporation
Event
Event 88112
Status
Terminated
Classification
Class II
Quantity
680 units
Official record key
device-enforcement:Z-2079-2021

Official wording

Reason: The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.

Code information: Catalog: 504-657A Lot 17919780: Exp. Date 12/31/2022 and Lot 17988227: Exp. Date 10/31/2023

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AR, AZ, FL, GA, IN, NC, NJ, and WV. The country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.