Venous Hardshell Cardiotomy Reservoir packaging pinholes may compromise sterility
Maquet Medical Systems is recalling Venous Hardshell Cardiotomy Reservoirs because packaging pinholes may compromise the sterile barrier, potentially exposing patients to non-sterile devices that could cause infection or sepsis.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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: This is an FDA Class II medical device recall describing a sterile barrier compromise with potential serious consequences including infection and sepsis. No hospitalizations or actual reported injuries are mentioned in the source, placing this in the risk-of-harm category where injury has not yet been reported.
Plain-English summary
The recalled products are the Venous Hardshell Cardiotomy Reservoir Models VKMO 10000-USA and VKMO 11000-USA, manufactured by Maquet Medical Systems USA. These devices are used in cardiopulmonary bypass procedures. The products were distributed nationwide to the United States.
The recall was issued because product packaging may have small pinholes that are not visible to the naked eye. These pinholes can compromise the sterile barrier of the packaging. If the sterile barrier is compromised, the device may be exposed to non-sterile conditions, which could result in inflammation, infection, sepsis, and ischemia.
All lots of both affected models are included in this recall. Individuals and healthcare facilities with these devices should contact Maquet Medical Systems USA for further information.
The recalled product
- Product
- Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445
- Manufacturer
- Maquet Medical Systems USA
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Maquet Medical Systems USA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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