Maquet Getinge-BEQ-T 3502 LVAD Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific LVAD tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.
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 is classified as FDA Class II. The hazard involves a potential failure of sterilization assurance (SAL) for a medical device used in extracorporeal circulation, which is a high-risk scenario for infection, but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-T 3502 LVAD 1/4" Material: 701068168 Custom Tubing Sets for Extracorporeal Circulation (ECC). The recall involves specific batch numbers: 3000042630, 3000053054, 3000054960, and 3000058830. The products were distributed nationwide.
The recall was initiated because the closed stopcock/non-vented cap configuration of the tubing sets may prevent the flow of humidity and ethylene oxide gas into the fluid path between the closed port and the non-vented cap during sterilization. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, which poses a risk of non-sterile medical devices being used in patients.
Healthcare facilities and users of these specific tubing sets should stop using the affected products immediately and contact Maquet Cardiovascular for instructions on return or replacement. This recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Maquet Getinge-BEQ-T 3502 LVAD 1/4" Material: 701068168
- Manufacturer
- Maquet Cardiovascular, LLC
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)
- Batch Numbers: 3000042630 3000053054 3000054960 3000058830
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 183 recalled by Maquet Cardiovascular, LLC 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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