FDA Device recall Z-1063-2016
Percutaneous Insertion Tray
- FDA Device
- Class I
- terminated
- Published 2016-03-16
On 2016-03-16 the FDA classified a Class I recall of Percutaneous Insertion Tray 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-1063-2016 |
| 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
Percutaneous Insertion Tray; Product Code: IAK-S7IT 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: 18F14A0037 18F14B0040 18F14E0027 18F14F0027 18F14F0028 |
|---|
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-1063-2016%22
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