Hudson 4100235000Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04546540068231), received between Jul 24, 2018 and Jul 29, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Material Fragmentation; Material Fragmentation

  THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: MATERIAL FRAGMENTATION. 1 EVENT HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22646529 ↗
• MalfunctionJul 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. 4 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19823237 ↗
• MalfunctionJan 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18557328 ↗
• MalfunctionOct 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. 3 EVENTS HAD NO PATIENT INVOLVEMENT, NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17993159 ↗
• MalfunctionJul 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  KR 7/28 THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17401907 ↗
• MalfunctionMay 23, 2023Overheating of Device; Overheating of Device

  THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16983537 ↗
• MalfunctionMay 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED, THAT THE DEVICE WAS DISASSEMBLED DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16964251 ↗
• MalfunctionApr 25, 2023Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16808041 ↗
• MalfunctionJan 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16261927 ↗
• MalfunctionFeb 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICE WAS DISASSEMBLED DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY.  THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11295672 ↗
• MalfunctionApr 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  PER SERVICE, SPRING AND RETAINING CLIP MISSING.

  Patient problems: No Patient Involvement

  MAUDE report 9995733 ↗
• MalfunctionApr 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICE WAS DISASSEMBLED DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY.  THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9995633 ↗
• MalfunctionMar 31, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICE DISASSEMBLED DURING INSPECTION AT THE MANUFACTURER FACILITY.  THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 9903127 ↗
• MalfunctionJun 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICE WAS MISSING COMPONENTS DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY.  THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8704756 ↗
• MalfunctionJun 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICE HAD A PIECE MISSING DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY.  THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8664448 ↗
• MalfunctionOct 29, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 8013985 ↗
• MalfunctionJul 24, 2018Material Disintegration; Material Disintegration

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS SHEDDING METAL DEBRIS. ONE EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 7714958 ↗