Maquet Cardiovascular Recalls QUADROX-i Neonatal Membrane Oxygenators
Maquet Cardiovascular is recalling QUADROX-i Neonatal membrane oxygenators due to a potential for blood leakage at the blood inlet connector when using a specific reducing screw adapter.
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 recall is classified as FDA Class I, which mandates a minimum severity score of 4 per the rubric, as the defect poses a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling the QUADROX-i Neonatal membrane oxygenator with integrated arterial filter and VHK 11000 (Part Number 701055207). The recall involves 490 units distributed in the United States and internationally. The affected lots are 92209374, 92211752, 92215106, 92222131, 92223169, 92228805, 92234286, and 92236876.
The recall is issued because there is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16. This leakage may result in clinically relevant loss of prime before patient connection or blood loss during patient connection. The device is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
The affected units were distributed nationwide in the US to the states of Arizona, California, Florida, Iowa, Louisiana, North Carolina, and Texas, as well as to numerous countries worldwide. Healthcare facilities should contact Maquet Cardiovascular for instructions on how to return or dispose of the affected devices.
The recalled product
- Product
- QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055207 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 — Cardiovascular
- 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 (9)
- UDI: 04037691773414
- Lots: 92209374
- 92211752
- 92215106
- 92222131
- 92223169
- 92228805
- 92234286
- 92236876
Distribution
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.
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