ANGIODYNAMICS Percutaneous Introducer Set under the following labels:… — Class III medical device recall Z-0774-2017
Terminated recall by Angiodynamics, Inc., reported 2016-12-28, distributed nationwide. Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the product
| Recall number | Z-0774-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Angiodynamics, Inc., Queensbury, NY, United States |
| Recall initiated | 2016-09-28 |
| Classified | 2016-12-16 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2018-06-18 |
| Distributed | Nationwide (US) |
| Quantity | 751 units |
| Reason classes | device malfunction |
| Model numbers | 06597050, 06597052, 06597054, H787065970505, H787065970525, H787065970545 |
Product
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970505, Catalog No.REF 06597050, 2) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO S PG, Item Number H787065970525, Catalog No.REF 06597052, 3) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO A PG, Item Number H787065970545, Catalog No.REF 06597054 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
Reason for recall
Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.
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-0774-2017. 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.