Cook Inc.: Medical Device Recall in 2019 - (Recall #: Z-0979-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: February 1, 2019

Date Posted: March 20, 2019

Recall Number: Z-0979-2019

Event ID: 82124

Reason for Recall:

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.

Status: Terminated

Product Quantity: 100

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.

Voluntary or Mandated:

Voluntary: Firm initiated