Guardian II Hemostasis Valve — Class I medical device recall Z-1275-2016
Terminated recall by Vascular Solutions, Inc., reported 2016-04-13, distributed nationwide. Vascular Solutions became aware of a potential problem with the click version of the Guardian II hemostasis va
| Recall number | Z-1275-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vascular Solutions, Inc., Maple Grove, MN, United States |
| Recall initiated | 2016-03-04 |
| Classified | 2016-04-07 |
| Reported by FDA | 2016-04-13 |
| Terminated | 2016-10-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | IE |
| Quantity | 5,283 |
| Reason classes | packaging |
| Lot numbers | 41776, 41777, 41874, 42108, 42525, 581766, 581767, 583285, 583286 |
| Model numbers | 8210, 8211 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1275-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.