NA 0210014100Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540861252), received between Aug 30, 2018 and Jul 24, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 7 most recent of 7 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 22587054 ↗
• MalfunctionJan 22, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY CONTAMINATED DURING MANUFACTURE OR SHIPPING. 1 EVENT HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207629 ↗
• 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 21207496 ↗
• MalfunctionOct 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 10 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. 6 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. 4 EVENTS HAD PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20504494 ↗
• MalfunctionOct 22, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY CONTAMINATED DURING MANUFACTURE OR SHIPPING. 1 EVENT HAD NO PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20504458 ↗
• MalfunctionJan 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 8 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. - 8 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18557621 ↗
• MalfunctionAug 30, 2018Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED BY THE CUSTOMER THAT A FOREIGN OBJECT WAS OBSERVED IN THE PACKAGE. THERE WAS NO IMPACT TO THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7832601 ↗