FDA Device recall Z-1061-2016
RediGuard IAB: 7Fr 30cc
- FDA Device
- Class I
- terminated
- Published 2016-03-16
On 2016-03-16 the FDA classified a Class I recall of RediGuard IAB: 7Fr 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-1061-2016 |
| 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
RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C 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:18F14A0041 18F14C0003 18F14C0006 18F14C0021 18F14C0026 18F14C0027 18F14C0028 18F14E0039 18F14E0055 18F14…Batch:18F14A0041 18F14C0003 18F14C0006 18F14C0021 18F14C0026 18F14C0027 18F14C0028 18F14E0039 18F14E0055 18F14E0058 18F14F0035 18F14F0038 18F14F0054 18F14G0057 18F14G0077 18F14H0011 18F15B0023 18F15C0001 18F15C0008 18F15C0026 18F15D0028 18F15F0027 18F15F0037 18F15G0003 18F15G0011 18F15G0032 18F15H0046 18F15M0009 |
|---|
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-1061-2016%22
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