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Recall Observatory FDA recall evidence

Device product

Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB

Z-2429-2021

July 21, 2021

Class I

Product summary

Firm
Cordis Corporation
Event
Event 88372
Status
Terminated
Classification
Class I
Quantity
1610 units
Official record key
device-enforcement:Z-2429-2021

Official wording

Reason: Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band movement or dislodgement.

Code information: all codes

Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band movement or dislodgement.