Agency classClass IIOur severity:High FDA (Devices)·Z-0160-2013·Announced 2012-11-07

Maquet Cardiovascular Recalls QUADROX Oxygenators Due to Connector Detachment Risk

Maquet Cardiovascular is recalling QUADROX oxygenators because the blood outlet connector may detach from the device during use.

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 (medical 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 models of QUADROX oxygenators, including the QUADROX iD HMOD 2030, QUADROX-i ADULT HMO 70000/71000, and QUADROX-iD Pediatric HMOD 30000. These devices are intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The recall covers 23,203 units distributed nationwide in the United States.

The recall was initiated because the blood outlet connector on some models may detach from the oxygenator. The firm noted that this event has occurred in approximately 0.01% (1 in 10,000) of units shipped. The affected products include various sizes and membrane types of QUADROX-i oxygenators, QUADROX-iR, HLS modules, and custom tubing packs containing the listed oxygenators.

Healthcare facilities and distributors should stop using the affected devices and contact Maquet Cardiovascular for further instructions. The recall is classified as Class II by the FDA, indicating a situation where use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000 Product Usage: The QUADROX oxygenators are intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within…
Manufacturer: Maquet Cardiovascular Us Sales, Llc
Category: Medical Device — Cardiac Surgery Equipment
Hazard: connector-detachment
device-failure
Affected units: 23,203

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 (20)

All sizes and membrane types of QUADROX-i oxygenators
i.e.
QUADROX-i(D) Adult
Small Adult
Pediatric and Neonatal with SOFTLINE and BIOLINE Coating
Catalogue numbers to include BE-HMOD XXXXX
BEQ-HMO XXXXX
BEQ-HMOD XXXX
BEQ-HMOD XXXXX
BO-VKMO XXXXXX
HMO XXXX
HMO XXXXX
HMOD XXXX
HMOD XXXXX
VKMO XXXX
VKMO XXXXX
X HMO XXXXX U
XHMOD 30000 U
X VKMO XXXXX U
TOP XXXXXns

Distribution

Distributed nationwide across the United States.

Same manufacturer · Maquet Cardiovascular Us Sales, Llc

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