AngioVac Circuit Pack — Class II medical device recall Z-1702-2016
Terminated recall by Angiodynamics Inc. (Navilyst Medical Inc.), reported 2016-06-01, distributed nationwide. Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the products may po
| Recall number | Z-1702-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Angiodynamics Inc. (Navilyst Medical Inc.), Glens Falls, NY, United States |
| Recall initiated | 2016-03-21 |
| Classified | 2016-05-20 |
| Reported by FDA | 2016-06-01 |
| Terminated | 2017-09-18 |
| Distributed | Nationwide (US) |
| Quantity | 377 kits |
| Reason classes | sterility |
| Lot numbers | 4876386, 4889699, 4889700, 4898652, 4902111, 4902117, 4906576, 4941511, 4941511D, 4943459, 4955686, 4956929, 4969475, 4975493, 4991710, 4999714 |
| Model numbers | 25-187, H965251870 |
Product
AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.
Reason for recall
Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the products may possess levels of endotoxin that exceed regulatory limits. AngioDynamics confirmed that the affected RotaFlow Centrifugal Pumps were included in packaged AngioVac Circuit Packs.
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-1702-2016. 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.