Z-0979-2019Class I

Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart...

Name: Z-0979-2019 Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart...
Creator: Cook Inc.
Published: 2019-02-01
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2019-02-01 / Terminated / root cause: manufacturing process

FDA source

Cook Inc. began a recall of Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures on 2019-02-01. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0979-2019
Classification: Class I
Status: Terminated
Initiated: 2019-02-01
Posted: 2019-03-13
Terminated: 2020-06-30
Recalling firm: Cook Incorporated
Product: Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.
Product code: DRC Trocar
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Urgent Medical Device Recall notification letters were sent to customers on 2/1/19. Action to take 1. Examine your inventory immediately to determine if you have affected product(s), and quarantine affected product(s). Immediately cease all distribution and use of these products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. NOTE: Unaffected products that are returned will not be credited. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return it via fax (812.339.7316) or email ([email protected]). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred. 5. Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time) or by email to [email protected].
Quantity in commerce: 100
Distribution: 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.
Product codes and lots: Lot 8833687

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0979-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0979-2019	Class I	Terminated	Voluntary: Firm initiated	2019-03-20	2019-03-13

Product code DRC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)