InterPulse 0210210000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327003918), received between Sep 13, 2018 and Nov 28, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (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 16, 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 28, 2018Biocompatibility; Biocompatibility

  THE USER FACILITY REPORTED THAT WATER CAME OUT OF THE BATTERY PACK WHEN THE BAG WAS SPIKED DURING A PROCEDURE. THERE WAS NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8111770 ↗
• MalfunctionSep 13, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WATER LEAKED FROM THE BATTERY BOX DURING A PROCEDURE. THERE WAS NO SURGICAL DELAY OR ADVERSE CONSEQUENCES TO THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7872311 ↗