Maquet Quadrox-iD Adult Diffusion Membrane Oxygenator Recalled for Blood Leakage Risk
Maquet Cardiovascular is recalling Quadrox-iD Adult Diffusion Membrane Oxygenators due to a potential issue that could result in blood leakage from the gas outlet port.
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, fitting the criteria for a High severity score.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling the Quadrox-iD Adult Diffusion Membrane Oxygenator. The recall affects all lots of the device with Bioline and Softline Coatings, Custom Tubing Packs, and Diffusion Membrane HLS Set Advanced and HIT Set Advanced Models. The product is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
The recall was initiated because a potential issue was detected that could result in blood leakage from the gas outlet port. The agency has classified this recall as Class II. The affected units were distributed worldwide, including the United States and numerous international markets.
Healthcare facilities and users should stop using the affected devices and contact the manufacturer for further instructions. The source text does not specify the number of reported injuries or illnesses associated with this potential issue.
The recalled product
- Product
- Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates…
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Hazard
- Affected units
- 10,199
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 (5)
- Part numbers BO-HMOD 70000
- 70105.3815
- BEQ-HMOD 70000
- 70105
- 3824
Distribution
Distributed nationwide across the United States.
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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