InterPulse 0210110100Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540861641), received between Oct 28, 2020 and Jan 22, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (4 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Nov 9, 2017Terminated

   Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

   Z-1246-2018 · Root cause: Environmental control · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2024Delivered 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 18556730 ↗
• MalfunctionOct 24, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  THIS REPORT SUMMARIZES 8 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. 8 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15663570 ↗
• MalfunctionOct 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12680265 ↗
• MalfunctionJan 22, 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 11215208 ↗
• MalfunctionOct 28, 2020Delivered 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 10748495 ↗