FDA Device recall Z-1275-2016
Guardian II Hemostasis Valve, models 8210 and 8211
- FDA Device
- Class I
- terminated
- Published 2016-04-13
On 2016-04-13 the FDA classified a Class I recall of Guardian II Hemostasis Valve, models 8210 and 8211 by Vascular Solutions, citing vascular Solutions became aware of a potential problem with the click version of the Guardian II hemostasis valves. The low pressure seal may not close properly, which may allow a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1275-2016 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-03-04 |
| Published | 2016-04-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Vascular Solutions |
| Distribution | US |
Product
Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US: FH101, FH101-T, FH101-25, and FH101-50. Product Usage: The Guardian hemostasis valves are designed to be used as conduits when interventional devices with diameters up to 8 F are inserted into the human vascular system. The devices have two seals: the low-pressure seal, and the high-pressure seal. Closure of the high-pressure seal, which is achieved when the nut can no longer rotate, secures the diagnostic/interventional device in position within the vasculature and allows for pressure injections up to 600 psi.
Reason
Vascular Solutions became aware of a potential problem with the click version of the Guardian II hemostasis valves. The low pressure seal may not close properly, which may allow air to be introduced into the device and may lead to risk of an air embolism.
Identifiers
| code_info | Lot numbers: 41776, 41777, 41874, 42108, 42525, 581766, 581767, 583285, and 583286. |
|---|
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-1275-2016%22
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