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
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
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.