QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator recallZ-2262-2013 · Maquet Cardiovascular Us Sales, Llc · initiated Aug 15, 2013
Class II Terminated All recalls posted in September 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Maquet Cardiovascular Us Sales, Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The manufacturer has conducted a review of the results of product testing performed during the last twelve months and has identified specific lots of product which may not meet specifications for bond strength on the inlet and/or outlet connector.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Maquet sent a Urgent Product Recall letter/Response Form, dated 8/15/2013 via Fed Ex. On 8/26/2013 Maquet sent a letter to their customers informing them that all shipments of oxygenators and stainless steel hold clamps have been placed on a temporary hold due to an agency review in connection with FDA clearance. Customer service may be contacted at 1-888-627-8383, (option 2 followed by option 2) Monday though Friday between the hours of 8:00 am and 6:00 pm EST. Maquet issued a Certificate of Medical Neccesity (CMN) on September 17, 2013 to notify Quadrox customers that they may continue to receive and use their current inventory of Quadrox oxygenators and clamps by acknowledging the conditions provided in the CMN.
Recall details
- Recall number
- Z-2262-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 15, 2013
- Posted by the FDA
- Sep 20, 2013
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Quantity
- 1,182 units
- Product code
- DTZ
- FDA submissions
- K082117, K090511, K090689, K093522, K103191, K112360
- Distribution
- Worldwide Distribution, including Nationwide (US) and foreign countries.
Product description
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.
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
4 devices cleared under K082117, K090511, K090689, K093522, K103191, K112360 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- HLS Set BEQ-HLS 7050 USAMaquet Cardiopulmonary AG · Oxygenator, Cardiopulmonary Bypass3 recalls13 deaths90 reports
- HLS Set BEQ-HLS 5050 USAMaquet Cardiopulmonary AG · Oxygenator, Cardiopulmonary Bypass3 recalls4 reports
- NA HLS Set Advanced 5.0, Small Adult, BIOLINE CoatingMaquet Cardiopulmonary AG · OXYGENATOR, CARDIOPULMONARY BYPASS3 recalls0 reports
- NA HLS Set Advanced 7.0, Adult, BIOLINE CoatingMaquet Cardiopulmonary AG · OXYGENATOR, CARDIOPULMONARY BYPASS2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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