# FDA recall Z-0979-2019

> **Cook Inc.** · Class I · device recall initiated 2019-02-01.

## Product

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

## 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.

## 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.

## Key facts

- **Recall number:** Z-0979-2019
- **Recalling firm:** Cook Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-01
- **Report date:** 2019-03-20
- **Termination date:** 2020-06-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomington, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0979-2019

## Citation

> AI Analytics. FDA recall Z-0979-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0979-2019. Source: US FDA. Licensed CC0.

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