Agency classClass IIOur severity:High FDA (Devices)·Z-1585-2019·Announced 2019-06-05

Maquet Getinge-BEQ-TOP 5208 ECC Set Cardiac Recall for Sterility Assurance

Maquet Cardiovascular is recalling specific batches of cardiac extracorporeal circulation sets because a design flaw may prevent proper sterilization of the stopcock ports.

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: The recall involves a medical device where the Sterility Assurance Level cannot be assured, representing a risk of harm (infection) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Maquet Cardiovascular, LLC is recalling the Maquet Getinge-BEQ-TOP 5208 ECC SET CARDIAC (Material: 701067350). The recall affects specific batch numbers: 3000044413, 3000049064, 3000050885, 3000054157, 3000058832, 3000062461, and 3000065084. The product was distributed nationwide.

The recall was initiated because the closed stopcock and non-vented cap configuration may prevent the flow of humidity and ethylene oxide gas into the fluid path during sterilization. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, creating a potential risk of non-sterile components being used in extracorporeal circulation procedures.

Healthcare facilities and users should identify any affected units by checking the batch numbers listed above. Users should stop using the affected products and contact Maquet Cardiovascular, LLC for further instructions on return or replacement.

The recalled product

Product: Maquet Getinge-BEQ-TOP 5208 ECC SET CARDIAC Material: 701067350
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Cardiac Surgery
Hazard: sterility-failure
infection-risk

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.

See all 183 products in this recall →

Same manufacturer · Maquet Cardiovascular, LLC

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Same hazard · sterility failure