Vascular Solutions Recalls Guardian II Hemostasis Valves Due to Air Embolism Risk
Vascular Solutions, Inc. is recalling Guardian II and Guardian II NC Hemostasis Valves used in cardiopulmonary bypass because air may be introduced into the device, potentially leading to 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Risk that air may be introduced into the device which may lead to an air embolism."
Plain-English summary
Vascular Solutions, Inc. is recalling the Guardian II and Guardian II NC Hemostasis Valves, which are used in cardiopulmonary bypass. The recall involves specific model numbers including FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, FH102-50, 8215, 8216, 8241, 8242, 8244, 8272, and 8274. The devices are intended to maintain hemostasis during the use of diagnostic and interventional devices during procedures.
The recall is being conducted because there is a risk that air may be introduced into the device, which may lead to an air embolism. The affected units were distributed worldwide, including in the United States and various countries in Europe, Asia, and the Middle East.
Healthcare facilities and distributors should stop using the affected devices and contact Vascular Solutions, Inc. for further instructions on the recall process.
The recalled product
- Product
- Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model numbers: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, FH102-50, 8215, 8216, 8241, 8242, 8244, 8272 and 8274. Vascular Solutions…
- Manufacturer
- Vascular Solutions, Inc.
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 79,869
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 (1)
- and 30238.
Distribution
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