Monarch™ System PMACS1IERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887761977495), received between Feb 18, 2026 and Feb 18, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).

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.

Most reported problems

Recent adverse event reports

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

• MalfunctionFeb 18, 2026Material Split, Cut or Torn

  ON 22-JAN-2026, A PATIENT CONTACTED TECHNICAL SERVICE TO REPORT THAT MONARCH MODEL 1000 ACS - BASIC (PRODUCT CODE PMACS1NA, SERIAL NUMBER (B)(6)), HAD POWER CORD DAMAGED WITH COPPER WIRE EXPOSED. THIS OCCURRED AT HOME DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24383832 ↗