QUADROX-i Pediatric, diffusion, BIOLINERecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 2 still open.

1 other recall cover devices cleared under the same FDA submission (K132829); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

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 · FDA record ↗

2. Nov 13, 2019Open, Classified

   Sterile barrier system may be compromised

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

Recalls under the same FDA submission

These recalls involve devices cleared under K132829. One submission often covers many models, so check the product and lot details in each record.

• Z-1689-2015 · Mar 5, 2015 · Terminated
  Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardio