FDA Device recall Z-0979-2019
Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364
- FDA Device
- Class I
- terminated
- Published 2019-03-20
On 2019-03-20 the FDA classified a Class I recall of Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364 by Cook, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0979-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-02-01 |
| Published | 2019-03-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cook |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot 8833687 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0979-2019%22
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