Valleylab E4051-CTRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884524000749), received between Aug 21, 2019 and Dec 22, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Melted; Peeled/Delaminated; Melted; Peeled/Delaminated

  IT WAS REPORTED THAT DURING A PROCEDURE, THE INSULATION OF THE DEVICE MELTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23862071 ↗
• MalfunctionSep 11, 2025Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO USE, THE BLUE PART ON THE INSIDE WAS CHIPPED. THIS WAS CONFIRMED BY THE PHOTOS RECEIVED, WHEREIN THE EDGES OF THE CHIPPED PART WAS ALSO CHARRED. IT WAS A NEWLY OPENED DEVICE AND HAD NOT BEEN USED MUCH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23026571 ↗
• MalfunctionAug 14, 2025Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER DURING SERVICING AT THE FACILITY, THE INNER BLUE PARTS OF THE DEVICES WERE CHIPPED/DAMAGED AFTER IT HAD ALREADY BEEN USED AND CLEANED/STERILIZED. PHOTOS WAS SUBMITTED SHOWING THE INSULATION WAS CHIPPED OFF. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22804087 ↗
• MalfunctionAug 14, 2025Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER DURING SERVICING AT THE FACILITY, THE INNER BLUE PARTS OF THE DEVICES WERE CHIPPED/DAMAGED AFTER IT HAD ALREADY BEEN USED AND CLEANED/STERILIZED. PHOTOS WAS SUBMITTED SHOWING THE INSULATION WAS CHIPPED OFF. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22803975 ↗
• MalfunctionAug 14, 2025Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER DURING SERVICING AT THE FACILITY, THE INNER BLUE PARTS OF THE DEVICES WERE CHIPPED/DAMAGED AFTER IT HAD ALREADY BEEN USED AND CLEANED/STERILIZED. PHOTOS WAS SUBMITTED SHOWING THE INSULATION WAS CHIPPED OFF. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22803833 ↗
• MalfunctionAug 14, 2025Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER DURING SERVICING AT THE FACILITY, THE INNER BLUE PARTS OF THE DEVICES WERE CHIPPED/DAMAGED AFTER IT HAD ALREADY BEEN USED AND CLEANED/STERILIZED. PHOTOS WAS SUBMITTED SHOWING THE INSULATION WAS CHIPPED OFF. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22803737 ↗
• MalfunctionJun 25, 2025Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE INNER BLUE PART WAS CHIPPED/DAMAGED. THE INSULATION WAS SLIGHTLY PEELED BUT NOT PEELED OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22328477 ↗
• MalfunctionJun 25, 2025Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, THE INNER BLUE PART WAS CHIPPED/DAMAGED.

  Patient problems: Insufficient Information

  MAUDE report 22328350 ↗
• MalfunctionMay 26, 2025Entrapment of Device; Arcing; Appropriate Device Problem Term/Code Not Available; Entrapment of Device; Arcing; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A BRAIN SURGERY, SEVERAL ISSUES OCCURRED, INCLUDING ARCING/SPARKING, AND THERE WAS ADHESIVE ISSUE WHERE THE PRODUCT WAS NOT EASILY REMOVED, LEADING TO TISSUE STICKING COMPLICATIONS. THE PATIENT WAS UNDER ANESTHESIA, AND THEY TOOK ANOTHER OPTION TO COMPLETE THE SURGERY BY USING ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 22084835 ↗
• MalfunctionDec 11, 2020Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PREPARATION, THE COATING OF THE DEVICE HAD PEELED OFF, THUS THE DEVICE WAS NOT USED IN THE OPERATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10993335 ↗
• MalfunctionAug 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING STERILIZATION PRIOR TO PROCEDURE, SOME PARTS OF THE DEVICE WAS COMING OFF. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 8918775 ↗