QUADROX-iRecalls & reported problems across all models

We found 10 models of QUADROX-i by Maquet Cardiopulmonary AG in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Feb 27, 2025 and Feb 27, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Infusion or Flow Problem” (1 report).

10 FDA recall records name at least one of these models by its device identifier, 8 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

QUADROX-i recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 18, 2023Open, Classified

   Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.

   Z-1659-2023 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗

2. May 18, 2023Open, Classified

   Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.

   Z-1658-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. May 18, 2023Open, Classified

   1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.

   Z-1639-2023 · Root cause: Pending · Recall details · FDA record ↗

4. May 18, 2023Open, Classified

   1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.

   Z-1638-2023 · Root cause: Pending · names 2 of these models · Recall details · FDA record ↗

5. May 18, 2023Open, Classified

   1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.

   Z-1637-2023 · Root cause: Pending · names 2 of these models · Recall details · FDA record ↗

6. May 18, 2023Open, Classified

   Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.

   Z-1657-2023 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗

7. May 18, 2023Open, Classified

   1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.

   Z-1636-2023 · Root cause: Pending · Recall details · FDA record ↗

8. Nov 13, 2019Open, Classified

   Sterile barrier system may be compromised

   Z-0677-2020 · Root cause: Package design/selection · Recall details · FDA record ↗

9. Oct 25, 2018Terminated

   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.

   Z-0437-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

10. Oct 25, 2018Terminated

    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.

    Z-0436-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported QUADROX-i problems

QUADROX-i models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• QUADROX-i Pediatric, diffusion, BIOLINE

  HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
  2 recalls0 reports
• QUADROX-i HMO 71000-USA #SQUADROX-i Adult + Coating, Filter

  OXYGENATOR, CARDIOPULMONARY BYPASS
  2 recalls0 reports
• QUADROX-i BEQ-HMO 71000-USA #SQUADROX-i Adult+BIOLINE +Filter

  HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
  2 recalls0 reports
• QUADROX-i HMO 50000-USA #SQUADROX-i Small Adult, no Filter

  OXYGENATOR, CARDIOPULMONARY BYPASS
  2 recalls0 reports
• QUADROX-i BEQ-HMO 50000-USA #SQUADR-i Small Ado.Fi / Small Adult, BIOLINE

  OXYGENATOR, CARDIOPULMONARY BYPASS
  2 recalls0 reports
• QUADROX-i HMO 70000-USA #SQUADROX-i Adult o.Filter

  Filter, blood, cardiopulmonary bypass, arterial line
  2 recalls0 reports
• QUADROX-i HMO 51000-USA #SQUADROX-i Small Ad.+Filter /Small Adult. Filter

  HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
  2 recalls0 reports
• QUADROX-i Neonatal, filter, reservoir

  Defoamer, cardiopulmonary bypass
  1 recall0 reports
• QUADROX-i Neonatal, reservoir

  Defoamer, cardiopulmonary bypass
  1 recall0 reports
• Quadrox-i SQUADROX-i HMO 70000+ VHK7000

  Antigens, Cf (Including Cf Control), Adenovirus 1-33
  1 report

Recent QUADROX-i adverse event reports

The 1 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT AT THE END OF THE TREATMENT THERE WAS A CLOT IN THE OXYGENATOR. THE PRODUCT WAS USED FOR ONE AND HALF HOURS. CUSTOMER STATES THAT THERE WAS NOT A SIGN OF POOR FUNCTION OF OXYGENATOR WAS DETECTED, FLOWS AND OXYGENATION WERE NOT AFFECTED. SINCE THE DEVICE HAD A CLOTTING DURING PATIENT TREATMENT AND THEREFORE THE DEVICE DID NOT FUNCTION AS EXPECTED, AS THIS COULD LEAD TO LACK OF FLOW/OXYGENATION THE COMPLAINT IS REPORTABLE. COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21478899 ↗

Other Maquet Cardiopulmonary AG products

• MAQUET CARDIOHELP5 models · 173 reports · 9 recalls
• HLS Set2 models · 94 reports · 5 recalls
• ROTAFLOW4 models · 14 reports · 4 recalls
• QUADROX-iD3 models · 0 reports · 4 recalls