Device 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.
Z-0297-2017
Product summary
- Event
- Event 75376
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 in USA
- Official record key
device-enforcement:Z-0297-2017
Official wording
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.
Code information: Product Model ACX101, Manufacturer UDI *+ M465ACX10106* Lot No: F1614503
Distribution pattern: US distribution to FL and NJ
Derived failure modes
-
Unknown
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.