---
title: "Cook Medical: Transseptal Needle and Transseptal Needle Catheter — FDA announcement Oct 19, 2021 | Is It on Recall"
description: "Complaints of rust on the products"
url: https://isitonrecall.com/recall/fdapress-b266f516639de15f-cook-medical-transseptal-needle-and-transseptal-needle-catheter/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA company announcement

# Cook Medical: Transseptal Needle and Transseptal Needle Catheter — FDA announcement Oct 19, 2021

Reported terminated

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Oct 19, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Transseptal Needle and Transseptal Needle Catheter
- **Reason**: Complaints of rust on the products
- **Classification**: Not supplied
- **Recalling firm**: Cook Medical
- **Quantity**: Not supplied
- **Agency-reported status**: Terminated in FDA listing
- **Source record identifier**: b266f516639de15f

[Open the official record](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cook-medical-issues-voluntary-recall-transseptal-needle-and-transseptal-needle-catheter)

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | PRODUCT BRAND NAME \| INTENDED USE \| REFERENCE PART NUMBER (RPN) \| ORDER NUMBER (GPN) \| LOT NUMBER / UDI \| RANGE OF MANUFACTURE DATES FOR AFFECTED PRODUCTS; Transseptal Needle \| Intended for transseptal left heart access in both diagnostic and interventional procedures \| TSNC-18-71.0 \| G02364 \| All \| October 02, 2016 through July 22, 2021; TSNC-19-56.0 \| G02365; Transseptal Needle with Catheter \| Intended to facilitate transseptal entry into the left atrium \| TSN-17-75.0-ENDRYS \| G19261 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

**FDA company announcement, table 1**

| PRODUCT BRAND NAME | INTENDED USE | REFERENCE PART NUMBER (RPN) | ORDER NUMBER (GPN) | LOT NUMBER / UDI | RANGE OF MANUFACTURE DATES FOR AFFECTED PRODUCTS |
| --- | --- | --- | --- | --- | --- |
| Transseptal Needle | Intended for transseptal left heart access in both diagnostic and interventional procedures | TSNC-18-71.0 | G02364 | All | October 02, 2016 through July 22, 2021 |
| Transseptal Needle | Intended for transseptal left heart access in both diagnostic and interventional procedures | TSNC-19-56.0 | G02365 | All | October 02, 2016 through July 22, 2021 |
| Transseptal Needle with Catheter | Intended to facilitate transseptal entry into the left atrium | TSN-17-75.0-ENDRYS | G19261 | All | October 02, 2016 through July 22, 2021 |

Announcement retrieved Oct 1, 2026. [Official announcement](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cook-medical-issues-voluntary-recall-transseptal-needle-and-transseptal-needle-catheter).

## Distribution

Not supplied

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Fda listing date**: Oct 19, 2021
- **Company announcement date**: Oct 18, 2021

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Customers that received products affected by the recall were sent prepaid labels in a recall information packet. The letters requested that all customers and distributors quarantine and discontinue use of all potentially affected units and return the affected products to Cook as soon as possible for credit. Customers in the U.S. and in Latin America should return affected product(s) to Cook Medical. Before returning affected product to Cook Medical, please obtain an RGA#. You may contact 800.457.4500, press option 5, and enter extension 151090 to obtain an RGA# and return address.

[Read the current instructions](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cook-medical-issues-voluntary-recall-transseptal-needle-and-transseptal-needle-catheter)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Cook Medical records](https://isitonrecall.com/brand/cook-medical/)