Agency classClass IOur severity:Critical FDA (Devices)·Z-1275-2016·Announced 2016-04-13

FDA Recalls Guardian II Hemostasis Valves Due to Air Embolism Risk

Vascular Solutions is recalling Guardian II Hemostasis Valves because the low-pressure seal may fail, potentially allowing air into the device and causing an air embolism.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly identifies the agency classification as Class I. According to the severity rubric, an FDA Class I recall mandates a score of 5 (Critical), as it represents a reasonable probability of serious adverse health consequences or death.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class I recall for the Guardian II Hemostasis Valve, models 8210 and 8211, manufactured by Vascular Solutions, Inc. The recall involves 5,283 units distributed nationwide in specific states and in Ireland. The affected lot numbers are 41776, 41777, 41874, 42108, 42525, 581766, 581767, 583285, and 583286.

The recall was initiated because the low-pressure seal on the click version of the valve may not close properly. This defect may allow air to be introduced into the device, which could lead to a risk of an air embolism in the patient. The Guardian hemostasis valves are designed to be used as conduits when interventional devices are inserted into the human vascular system.

Healthcare providers and facilities should stop using the affected devices immediately. Vascular Solutions, Inc. is responsible for managing the recall and will contact customers to arrange for the return or replacement of the units. Consumers should not use these devices if they have them in their possession.

The recalled product

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…
Manufacturer: Vascular Solutions, Inc.
Category: Medical Device — Vascular Access
Hazard: air-embolism
seal-failure
Affected units: 5,283

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

Lot numbers: 41776
41777
41874
42108
42525
581766
581767
583285
and 583286.

Distribution

Distributed nationwide across the United States.

The notice also names 31 states specifically:

Same manufacturer · Vascular Solutions, Inc.

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Same hazard · air embolism