Cook Transseptal Needle — Class I medical device recall Z-0979-2019
Terminated recall by Cook Inc., reported 2019-03-20, distributed nationwide. The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside o
| Recall number | Z-0979-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2019-02-01 |
| Classified | 2019-03-13 |
| Reported by FDA | 2019-03-20 |
| Terminated | 2020-06-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 100 |
| Lot numbers | 8833687 |
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.
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-0979-2019. 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.