InterPulse 0210118000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540144256), received between Jan 12, 2017 and Jun 10, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, IT WAS REPORTED THAT A PIECE OF THE IRRIGATOR DETACHED WITHOUT BEING NOTICED AT THE TIME OF OCCURRENCE. SUBSEQUENTLY, A SMALL PLASTIC FRAGMENT WAS DISCOVERED WITHIN THE PATIENT'S RIGHT HIP JOINT SPACE. THE FRAGMENT WAS SUCCESSFULLY RETRIEVED, AND THE JOINT SPACE WAS INSPECTED. NO ADDITIONAL DETACHED MATERIAL OR DEVICE FRAGMENTS WERE IDENTIFIED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25455918 ↗
• MalfunctionOct 22, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20504483 ↗
• MalfunctionJul 24, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19823078 ↗
• MalfunctionAug 29, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE TIP WAS NOT ATTACHED TO THE HANDPIECE PRIOR TO A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7830681 ↗
• MalfunctionJun 14, 2018Biocompatibility; Biocompatibility

  THE USER FACILITY REPORTED THAT THE THERE WAS A HAIR ON THE INSTRUMENT INSIDE THE STERILE PACKAGE UPON OPENING THE PACKAGE. THERE WAS NO PATIENT IMPACT, NO CLINICALLY SIGNIFICANT DELAY, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Patient Involvement

  MAUDE report 7600756 ↗
• MalfunctionJan 12, 2017Disassembly; Disassembly

  THE USER FACILITY REPORTED THAT THE DEVICE'S TIP BROKE DURING A PROCEDURE. THERE WAS NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6245690 ↗