PIRANHA 2208121Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04055207064061), received between Nov 3, 2020 and Nov 6, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2020Overheating of Device; Overheating of Device

  THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE EVALUATION/INVESTIGATION. THE DEVICE WAS RECEIVED AND VISUALLY, FUNCTIONALLY AND ELECTRICALLY EVALUATED. THE REPORTED CONDITION WAS NOT CONFIRMED. THE DEVICE WAS CHECKED, NO ERRORS WERE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10803242 ↗
• MalfunctionNov 3, 2020Suction Problem; Suction Problem

  RWMIC DEVICE EVALUATION 01/27/2021: FINDINGS: ACCORDING OUT TEST INSTRUCTION PAO 1-001-8914 NO FAILURE FOUND. DURING THE INSPECTION OF THE CONNECTING CABLE TYPE 2208121 NO DEFECT/ERROR COULD BE DETECTED. THE FOOT SWITCH TYPE 2030 I 08 MUST NOT BE ACTUATED UNTIL "READY FOR USE" APPEARS ON THE DISPLAY OF THE TYPE 2208011, OTHERWISE THE ERROR MESSAGE "FOOTSWITCH IN USE/ DEFECTIVE PLEASE CHECK" APPEARS, SEE GA-A252 CHAPTER 7.1. IT IS HIGHLY PROBABLE THAT THE FOOTSWITCH IS ACTUATED DURING VACUUM BUILDUP OR THAT THE VACUUM IS TOO LOW. PIRANHA MODE OR SUCTION MODE CANNOT BE ACTIVATED ERROR "FOOT SWITCH DEFECTIVE" CHECK FOR CORRECT TUBE CONNECTIONS. DUE TO NO FAULT COULD BE FOUND, NO ACTIONS WILL BE CARRIED OUT. THE REPORTED CONDITIONS COULD NOT BE CONFIRMED.

  Patient problems: Insufficient Information

  MAUDE report 10779271 ↗