The PAXWIRE Occlusion Balloon System consists of an occlusion catheter — Class II medical device recall Z-0297-2017
Terminated recall by AccessClosure, Inc., A Cardinal Health Company, reported 2016-11-02, distributed in FL, NJ. AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE Occlusion Balloon System device because it was
| Recall number | Z-0297-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AccessClosure, Inc., A Cardinal Health Company, Santa Clara, CA, United States |
| Recall initiated | 2016-10-06 |
| Classified | 2016-10-21 |
| Reported by FDA | 2016-11-02 |
| Terminated | 2016-11-14 |
| Distributed | FL, NJ |
| Quantity | 6 in |
| Reason classes | device malfunction |
| Lot numbers | F1614503 |
| Model numbers | ACX101 |
Product
The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed for use in the iliofemoral artery to provide temporary occlusion as well as a path for dilator and/or sheath introduction, removal or repositioning during catheterization procedures.
Reason for recall
AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE Occlusion Balloon System device because it was made aware from customers that the device may be removed in the absence of vascular sheath across the arteriotomy. This is a deviation from the firm's standard catheterization technique.
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-0297-2017. 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.