Transseptal Needle with Catheter — Class II medical device recall Z-0223-2022
Terminated recall by Cook Inc., reported 2021-11-24, distributed nationwide. Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected
| Recall number | Z-0223-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2021-10-08 |
| Classified | 2021-11-12 |
| Reported by FDA | 2021-11-24 |
| Terminated | 2024-02-14 |
| Distributed | Nationwide (US) |
| Quantity | 4,789 |
| UPC / GTIN / UDI-DI | 00827002192614 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0223-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.