FDA Device recall Z-1059-2016
UltraFlex IAB: 7.5Fr 30cc
- FDA Device
- Class I
- terminated
- Published 2016-03-16
On 2016-03-16 the FDA classified a Class I recall of UltraFlex IAB: 7.5Fr 30cc by Arrow International Division, citing the sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1059-2016 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-02-10 |
| Published | 2016-03-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Arrow International Division |
| Distribution | US |
Product
UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.
Reason
The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.
Identifiers
| code_info | Batch: 18F13M0016 18F14A0017 18F14A0018 18F14A0022 18F14A0046 18F14E0054 18F14E0070 18F14G0038 18F14G0078 18F1…Batch: 18F13M0016 18F14A0017 18F14A0018 18F14A0022 18F14A0046 18F14E0054 18F14E0070 18F14G0038 18F14G0078 18F14H0007 18F14J0007 18F14J0025 18F14K0016 18F15A0035 18F15B0006 18F15B0014 18F15C0019 18F15E0028 18F15F0016 18F15G0007 18F15H0009 18F15H0035 |
|---|
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-1059-2016%22
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