# FDA recall Z-0223-2022

> **Cook Inc.** · Class II · device recall initiated 2021-10-08.

## Product

Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS.  GPN G19261.     Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle

## Reason for recall

Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used ranges from increased procedural time to inflammatory reactions, which at their most severe include systemic reactions potentially leading to permanent impairment or death.

## Distribution

Domestic distribution nationwide. Foreign distribution worldwide.

## Key facts

- **Recall number:** Z-0223-2022
- **Recalling firm:** Cook Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-10-08
- **Report date:** 2021-11-24
- **Termination date:** 2024-02-14

- **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-0223-2022

## Citation

> AI Analytics. FDA recall Z-0223-2022. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-0223-2022. Source: US FDA. Licensed CC0.

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