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QUADROX-iDRecalls & reported problems across all models

Maquet Cardiopulmonary AG · 3 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

4 open recalls name at least one QUADROX-iD model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls
4

We found 3 models of QUADROX-iD by Maquet Cardiopulmonary AG in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

4 FDA recall records name at least one of these models by its device identifier, 4 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-iD 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-1658-2023 · Root cause: Under Investigation by firm · 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-1656-2023 · Root cause: Under Investigation by firm · names 2 of these models · 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-1635-2023 · 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-1634-2023 · Root cause: Pending · Recall details · FDA record ↗

QUADROX-iD models

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

Other Maquet Cardiopulmonary AG products

All Maquet Cardiopulmonary AG devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page