Valleylab E2401Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20884524001828), received between Apr 14, 2017 and May 28, 2019 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE DEVICE ADHESIVE BACKING CAME OFF INSIDE OF PATIENT. RADIOPAQUE MARKER IDENTIFIED AS A RETAINED FOREIGN BODY DURING ROUTINE POST-OP X-RAY. AFTER CAREFUL CONSIDERATION, IT WAS DECIDED THAT THE FRAGMENT SHOULD BE LEFT IN PLACE AS IT COULD CAUSE MORE POTENTIAL ISSUES IF REMOVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8645904 ↗
• InjuryOct 18, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING USE, WHEN THE PIECE OF THE TIP CLEANER IN HALF WAS CUT, A TRACE OF THE MARKER WAS DETECTED IN THE PATIENT THROUGH AN X-RAY.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 7979091 ↗
• InjuryMay 9, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPY, THE PATIENT HAD RETAINED A RADIOPAQUE STRIPE OF THE SURGICAL PENCIL SCRATCH PAD. IT WAS DECIDED THAT THE FOREIGN BODY WOULD BE REMOVED DURING ANOTHER SCHEDULED SURGERY.

  Patient problems: No Information

  MAUDE report 7500025 ↗
• MalfunctionApr 14, 2017Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THE PADS AREN'T STICKING TO THE DRAPE. THEY'VE HAD A COUPLE TIP CLEANERS GO INTO THE PATIENT WHICH THE TECH SAW RIGHT AWAY. THE TIP CLEANER WAS RETRIEVED WITHOUT ANY INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6494334 ↗
• MalfunctionApr 14, 2017Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THE PADS AREN'T STICKING TO THE DRAPE. THEY'VE HAD A COUPLE TIP CLEANERS GO INTO THE PATIENT WHICH THE TECH SAW RIGHT AWAY. THE TIP CLEANER WAS RETRIEVED WITHOUT ANY INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6494316 ↗