Cook Inc. recalls Cook Transseptal Needle, Reference Number TSNC-18-71.0, Orde
Recalled Product
Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.
Hazard / Issue
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.
Issued by
FDA
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