Vasoshield Syringe Ink Chips May Cause Embolic Events
Ink on the Vasoshield syringe may chip off, potentially causing blood clots and foreign body reactions in patients. About 9,817 devices are affected.
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: FDA Class II recall with potential for serious harm (embolic events, blood clots, foreign body reactions) but no reported illnesses or injuries. The hazard is theoretical, placing this in the High severity category.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the Hemopro 2 with Vasoshield, Model VH-4001. The recall affects approximately 9,817 devices distributed nationwide in the United States, as well as in Japan and Germany.
The syringe has a Maquet logo printed in ink that may chip or flake during use. If ink particles enter the patient's bloodstream, they could cause serious complications including blood clots in coronary arteries, blood clots in peripheral blood vessels, or a foreign body reaction.
Healthcare facilities and providers using this device should immediately discontinue use and contact Maquet Cardiovascular, LLC for guidance. Patients who have already been treated with an affected device should consult their healthcare provider about potential risks and recommended monitoring.
The recalled product
- Product
- Hemopro 2 with Vasoshield, Model VH-4001
- Manufacturer
- Maquet Cardiovascular, LLC
- Hazard
- foreign-body
- coronary-embolism
- peripheral-embolism
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 (20)
- UDI-DI: 00607567700901
- Serial Numbers: 25152107
- 25152204
- 25152293
- 25152463
- 25152771
- 25153153
- 25153273
- 25153366
- 25153585
- 25153847
- 25153960
- 25154066
- 25154880
- 25155262
- 25155326
- 25155785
- 25156245
- 25156642
- 25157016
Distribution
Distributed nationwide across the United States.
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