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Recall Observatory FDA recall evidence

Device product

Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.

Z-0250-2020

October 04, 2019

Class II

Product summary

Firm
Cordis Corporation
Event
Event 83977
Status
Terminated
Classification
Class II
Quantity
21 units
Official record key
device-enforcement:Z-0250-2020

Official wording

Reason: Product was manufactured utilizing an expired inner body.

Code information: Catalog Number: 4171460S; Lot Number: 82169860; Expiry Date: 10/31/2020

Distribution pattern: US distribution to AL, AZ, FL, MN, and MO

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product was manufactured utilizing an expired inner body.