Interpulse 0210158000Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07613327351002), received between Jun 29, 2018 and Jul 24, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (9 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN APRIL 1 ¿ JUNE 30, 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: DEVICE CONTAMINATED DURING MANUFACTURE OR SHIPPING. - 1 EVENT HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587118 ↗
• MalfunctionJan 22, 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 INSUFFICIENT INFORMATION RECEIVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18556461 ↗
• MalfunctionJul 26, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. - 1 EVENT HAD INSUFFICIENT INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 15101952 ↗
• MalfunctionApr 25, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. 3 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14193208 ↗
• MalfunctionJan 19, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13289675 ↗
• MalfunctionOct 21, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12677874 ↗
• MalfunctionJan 22, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  THIS REPORT SUMMARIZES 20 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. 20 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11215145 ↗
• MalfunctionApr 24, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  THIS REPORT SUMMARIZES <NOE> 11 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. 10 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9997089 ↗
• MalfunctionApr 24, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9997086 ↗
• MalfunctionJan 28, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  THIS REPORT SUMMARIZES <NOE> 6 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. 6 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 9636414 ↗
• MalfunctionApr 9, 2019Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE DEVICE LEAKED FLUID FROM THE BATTERY PACK DURING A PROCEDURE. THERE WAS NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8496103 ↗
• MalfunctionFeb 7, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  THE USER FACILITY REPORTED THAT A FOREIGN OBJECT WAS FOUND IN THE TUBING FOUND PRIOR TO USE DURING INSPECTION. THERE WAS NO PATIENT IMPACT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8315193 ↗
• MalfunctionDec 5, 2018Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED, THE DEVICE WAS LEAKING FLUID FROM THE BATTERY PACK DURING A PROCEDURE. NO MEDICAL INTERVENTION, NO DELAY AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8134702 ↗
• MalfunctionNov 28, 2018Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED FLUID WAS LEAKING FROM THE BATTERY PACK DURING A PROCEDURE. THERE WAS NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8111939 ↗
• MalfunctionJun 29, 2018Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE DEVICE WAS HOT. THERE WAS NO MEDICAL INTERVENTION, ADVERSE CONSEQUENCES OR CLINICALLY SIGNIFICANT SURGICAL DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7652527 ↗