Cascade IOMAX Intraoperative Monitor 190296-200Recalls & reported problems

Summary

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

3 FDA recall records name this device's identifier, 3 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Aug 18, 2026Open, Classified

   Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrical stimulation to the patient, or allow an unintended electrical current to reach the patient.

   Z-0141-2027 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. May 17, 2024Class IIOpen, Classified

   Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation.

   Z-2349-2024 · Root cause: Process design · Recall details · FDA record ↗

3. Apr 23, 2024Class IIOpen, Classified

   There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potential unintended shock to the patient.

   Z-1882-2024 · Root cause: Process design · Recall details · FDA record ↗