Agency classClass IIOur severity:Severe FDA (Devices)·Z-1670-2019·Announced 2019-06-05

Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization gas flow, compromising sterility.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe. While no specific injuries are reported in the text, the failure of a critical safety control (sterility) in a medical device used for extracorporeal circulation carries a high risk of serious harm (infection), aligning with the Severe category for Class II recalls with significant potential harm.

Plain-English summary

Maquet Cardiovascular, LLC is recalling specific custom tubing sets for extracorporeal circulation (ECC). The affected product is the Maquet Getinge BEQ-T 3501 LVAD 3/8" tubing, with material number 701068008R01 and batch number 3000074094. The recall is classified as Class II by the U.S. Food and Drug Administration.

The recall is due to a potential sterilization failure. During the sterilization process, the closed stopcock and non-vented cap configuration may prevent the flow of humidity and ethylene oxide gas into the fluid path between the closed port and the cap. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, meaning the product may not be sterile.

The affected units were distributed nationwide. Healthcare facilities and users of these specific tubing sets should stop using the affected batch and contact Maquet Cardiovascular for further instructions on replacement or return.

The recalled product

Product: Maquet Getinge BEQ-T 3501 LVAD 3/8" Material: 701068008R01
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Cardiovascular / Extracorporeal Circulation
Hazard: sterility-failure
infection-risk

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: 3000074094

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 →

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Same hazard · sterility failure