Maquet recalls Venous Hardshell Cardiotomy Reservoirs with potential packaging pinholes that could allow contamination. Affected units may risk infection during surgery. Contact for return instructions.
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
Maquet is recalling Venous Hardshell Cardiotomy Reservoirs used in heart surgery because their packaging might have tiny pinholes that aren't visible to the naked eye. This could let non-sterile materials get inside, causing infections or other serious complications during surgery.
The packaging might have small pinholes that aren't visible without help. If non-sterile materials get inside the packaging, it could lead to infections, inflammation, or other serious complications during surgery.
Healthcare professionals using these reservoirs during heart surgery are most at risk. Patients undergoing cardiopulmonary bypass procedures may be affected if the reservoir is used with compromised packaging.
Check for the model numbers VKMO 10000-USA (701070441) or VKMO 11000-USA (701070445) on the packaging. All lots of these products are affected.
Look for the model numbers VKMO 10000-USA (701070441) or VKMO 11000-USA (701070445) on the packaging.
The product may have packaging pinholes that could lead to infection if used without proper sterility, so it should not be used until the recall is addressed.
Check for model numbers VKMO 10000-USA (701070441) or VKMO 11000-USA (701070445) on the packaging. All lots are affected.
The recall does not specify a remedy, so contact Maquet Medical Systems USA for instructions.
We’ve drafted a message you can send Maquet Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1661-2023 — Maquet Medical Systems Maquet Medical Systems Hello, I own a Maquet Medical Systems that is covered by recall Z-1661-2023 from Maquet Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
