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Recall Observatory FDA recall evidence

Device product

Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.

Z-0979-2019

February 01, 2019

Class I

Product summary

Firm
Cook Inc.
Event
Event 82124
Status
Terminated
Classification
Class I
Quantity
100
Official record key
device-enforcement:Z-0979-2019

Official wording

Reason: The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside of the introducer during needle insertion.

Code information: Lot 8833687

Distribution pattern: US nationwide and Canada. US distribution to the following states: AZ, FL, IL, IN, KS, MA, MI, MO, PA, SC, TN, and WA. The products were distributed to the following foreign countries: Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside of the introducer during needle insertion.