The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0436-2019·Announced 2018-12-05

Maquet QUADROX-i Neonatal Membrane Oxygenator Recalled for Blood Leakage Risk

Maquet is recalling QUADROX-i Neonatal membrane oxygenators because a specific reducing screw adapter may cause blood leakage at the inlet connector.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "There is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16 that may result in clinically relevant loss of prime before patient connection or blood loss during patient connection."

Plain-English summary

Maquet Cardiovascular US Sales, LLC is recalling the QUADROX-i Neonatal membrane oxygenator (Part Number 701055120) used in extracorporeal circulation during cardiac surgery. The recall involves 490 units distributed in the United States and internationally.

The recall is due to a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16. This defect may result in clinically relevant loss of prime before patient connection or blood loss during patient connection.

Healthcare facilities and users should stop using the affected devices and contact Maquet Cardiovascular for instructions on return or replacement. The affected lots are 92212343, 92214685, and 92225187.

The recalled product

Product
QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
Manufacturer
Maquet Cardiovascular Us Sales, Llc
Category
Medical Device — Cardiac Surgery Equipment
Hazard
Affected units
490

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)

  • UDI: 04037691780139
  • Lots: 92212343
  • 92214685
  • 92225187

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Maquet Cardiovascular Us Sales, 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 2 products in this recall →

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