Use cautionMedical device recall · FDA · Published February 1, 2019
Cook Transseptal Needle Recall: Risk of Heart Damage During Insertion
Cook recalls transseptal needles with missing back bevel that could damage heart introducer during procedure. Affected models include TSNC-18-71.0 (Order G02364).
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.
Take action
Contact the company
📍Recalling firmCook Inc.750 N Daniels Way · Bloomington, IN 47404-9120
“Cook Transseptal Needle Recall: Risk of Heart Damage During Insertion.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69064-cook-transseptal-needle-recall-risk-of-heart-damage-during-insertion. Based on FDA recall #Z-0979-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0979-2019%22&limit=1).
Cook Inc. recalled Cook Transseptal Needles (Ref No. TSNC-18-71.0, Order No. G02364) for a manufacturing defect that could damage introducers during insertion. The Food and Drug Administration announced the Class I recall on Feb. 1, 2019.
How to tell if you have it
Brand: Cook
Product: Cook Transseptal Needle
Reference Number: TSNC-18-71.0
Order Number: G02364
Lot Code: 8833687
Quantity: 100 units
Distribution: US nationwide (AZ, FL, IL, IN, KS, MA, MI, MO, PA, SC, TN, WA) and Canada
The hazard
The needles were manufactured without a back bevel on the needle tip. This defect could cause damage to the inside of the introducer during needle insertion.
Context
GovInfoNow's records show Cook Inc. has 38 other recalls on record since July 31, 2017. Other recent recalls include the Cook Flexor Check-Flo Introducer Ansel Modification recall (Nov. 12, 2021) and the Cook Skinny Needle with Chiba Tip Recall (Oct. 13, 2021). Additional similar products recalled include Cook Ring Transjugular Intrahepatic Access Sets (Nov. 26, 2025), Cook Centimeter Sizing Catheters (April 2, 2026), and Cook Aurous Sizing Catheters (April 2, 2026).
How to tell if you have this one
Check for the reference number TSNC-18-7:0 and order number G02364 on the needle packaging. The lot number 8833687 is also associated with this recall.
Brand
Cook
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Needle Packaging
Look for reference number TSNC-18-71.0 and order number G02364 on the needle packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 12 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Florida, Illinois, Indiana, Kansas, Massachusetts, Michigan, Missouri, Pennsylvania, South Carolina, Tennessee, Washington.
Recall timeline
FDA terminated this recall 17 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0979-2019 (February 1, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0979-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.