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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of air embolism, a serious medical condition, but the source text does not report any specific injuries or illnesses, fitting the criterion for risk-of-harm products where injury has not yet been reported.
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 Ze
- 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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