Agency classClass IIOur severity:High FDA (Devices)·Z-1590-2019·Announced 2019-06-05

Maquet Getinge-BEQ-T 3501 LVAD Tubing Sets Recalled for Sterility Assurance Issues

Maquet Cardiovascular is recalling specific LVAD tubing sets because a design feature may prevent sterilization gas from reaching all parts, 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 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 sterility cannot be assured, creating a risk of infection or harm during use, but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products without reported injury.

Plain-English summary

Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-T 3501 LVAD tubing sets (Material 701068008) due to a potential sterility assurance issue. The affected products are identified by batch numbers 3000042629 and 3000057758 and were distributed nationwide.

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

Healthcare facilities and users should stop using the affected tubing sets immediately and contact Maquet Cardiovascular for further instructions on replacement or return. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product: Maquet Getinge-BEQ-T 3501 LVAD/ 3/8" Material: 701068008
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Cardiovascular / LVAD
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: 3000042629 3000057758

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