FDA Device recall Z-0297-2017
The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes
- FDA Device
- Class II
- terminated
- Published 2016-11-02
On 2016-11-02 the FDA classified a Class II recall of The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes by Accessclosure A Cardinal Health, citing 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 absen….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0297-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-06 |
| Published | 2016-11-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Accessclosure A Cardinal Health |
| Distribution | FL, NJ |
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
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.
Identifiers
| code_info | Product Model ACX101, Manufacturer UDI *+ M465ACX10106* Lot No: F1614503 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0297-2017%22
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