NA 0210010000Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04546540144164), received between Jun 14, 2018 and Jan 22, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 0 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207545 ↗
• MalfunctionOct 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 9 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. 8 EVENTS HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20504482 ↗
• MalfunctionJul 24, 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 NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19823110 ↗
• MalfunctionJan 28, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

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

  Patient problems: No Patient Involvement

  MAUDE report 9636757 ↗
• MalfunctionDec 9, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT AT THE USER FACILITY, A FOREIGN MATERIAL WAS FOUND IN THE PACKAGE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING PREPARATION AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 9438932 ↗
• MalfunctionMay 21, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  THE USER FACILITY REPORTED THAT THE HAIR WAS DISCOVERED IN THE PACKAGE PRIOR TO OPENING. THERE WAS NO PATIENT IMPACT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8628716 ↗
• MalfunctionSep 20, 2018Biocompatibility; Biocompatibility

  THE USER FACILITY REPORTED THERE WAS DEBRIS INSIDE THE PEEL PACK FOUND PRIOR TO A PROCEDURE. THERE WAS NO PATIENT IMPACT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7893389 ↗
• InjuryJun 14, 2018Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE THE TIP OF THE DEVICE FELL INTO THE PATIENT. THE DEVICE MATERIAL WAS SUCCESSFULLY REMOVED. NO CLINICALLY SIGNIFICANT MEDICAL DELAY OR ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7600765 ↗