Agency classClass IIOur severity:High FDA (Devices)·Z-2262-2013·Announced 2013-10-02

Maquet Cardiovascular Recalls QUADROX Oxygenators Due to Bond Strength Defects

Maquet Cardiovascular is recalling specific lots of QUADROX oxygenators used in cardiac surgery because they may not meet specifications for bond strength on connectors.

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 is classified as FDA Class II and involves a risk-of-harm product (cardiac surgery device) where injury has not yet been reported, meeting the criteria for a High severity score.

Plain-English summary

Maquet Cardiovascular US Sales, LLC is recalling specific lots of QUADROX iD HMOD 2030 Diffusion Membrane Oxygenators, QUADROX-i ADULT HMO 70000 / HMO 71000, and QUADROX-iD Pediatric HMOD 30000. These medical devices are intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The recall involves 1,182 units distributed worldwide, including in the United States and foreign countries.

The manufacturer conducted a review of product testing results from the last twelve months and identified that specific lots may not meet specifications for bond strength on the inlet and/or outlet connector. The affected lots are: QUADROX-iD Adult catalog number HMOD 70000, lot # 70081567; QUADROX-i Adult catalog number VKMO 70000, lot # 70082663; and QUADROX-i Adult catalog number VKMO 71000, lot # 70083974.

This is an FDA Class II recall. Healthcare facilities and distributors should stop using the affected lots and contact the manufacturer for instructions on return or replacement. No injuries or illnesses have been reported in connection with this recall.

The recalled product

Product: QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
Manufacturer: Maquet Cardiovascular Us Sales, Llc
Category: Medical Device — Cardiac Surgery
Hazard: structural-defect
connector-failure
Affected units: 1,182

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 (4)

QUADROX-iD Adult catalog number HMOD 70000
lot # 70081567 QUADROX-i Adult catalog number VKMO 70000
lot # 70082663 QUADROX-i Adult catalog number VKMO 71000
lot # 70083974

Distribution

Distributed nationwide across the United States.

Same manufacturer · Maquet Cardiovascular Us Sales, Llc

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