Valleylab E6008BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884524001647), received between Jan 9, 2018 and Jul 9, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Energy Output To Patient Tissue Incorrect” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2019Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING SERVICING, THE DEVICE HAD A FAULTY CONFIGURATION OF CUT AND COAGULATION PEDALS, PEDALS WERE SWAPPED IN THEIR CONFIGURATION WITH THE BLUE COAGULATION ON THE LEFT AND YELLOW CUT ON THE RIGHT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8772952 ↗
• MalfunctionJan 9, 2018Energy Output To Patient Tissue Incorrect; Failure to Deliver Energy; Energy Output To Patient Tissue Incorrect; Failure to Deliver Energy

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE¿S FOOT PEDAL HAD NO COAGULATION OUTPUT. AS A RESULT, THE PROCEDURE WAS INTERRUPTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7176322 ↗