Edge E1455-4NSBRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521038486), received between Aug 3, 2018 and Nov 24, 2025 — classified as 1 injury, 8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Peeled/Delaminated; No Apparent Adverse Event; Peeled/Delaminated; No Apparent Adverse Event

  IT WAS REPORTED THAT, DURING PROCEDURE, THE DEVICE'S LENGTH FELT SHORTER THAN USUAL SO USAGE WAS DISCONTINUED. THERE WAS NO PATIENT HARM/INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE DEVICE'S INSULATION WAS DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631305 ↗
• MalfunctionMay 17, 2024Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING USE, THE BOVIE TIP WITH A GUARDED TIP ATTACHED, THE GUARD STARTED TO MELT. THE SURGEON STOPPED USING IT AND SWITCH OUT THE TIP. THE DEVICE DID NOT BREAK DURING PROCEDURE NOR FELL IN THE PATIENT'S CAVITY. THERE WERE NO BROKEN PIECE REMOVED/RETRIEVED AND NO ADDITIONAL PROCEDURE NEEDED. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 19346946 ↗
• MalfunctionJan 16, 2024Peeled/Delaminated; Material Twisted/Bent; Peeled/Delaminated; Material Twisted/Bent

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE ELECTRODE WAS ARTICULATING AND THE SCALPEL TIP COATING PART WAS PEELING OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518495 ↗
• MalfunctionJan 16, 2024Peeled/Delaminated; Material Twisted/Bent; Peeled/Delaminated; Material Twisted/Bent

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE ELECTRODE WAS ARTICULATING AND THE SCALPEL TIP COATING PART WAS PEELING OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518461 ↗
• MalfunctionJan 16, 2024Peeled/Delaminated; Material Twisted/Bent; Peeled/Delaminated; Material Twisted/Bent

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE ELECTRODE WAS ARTICULATING AND THE SCALPEL TIP COATING PART WAS PEELING OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518434 ↗
• MalfunctionJan 16, 2024Peeled/Delaminated; Material Twisted/Bent; Peeled/Delaminated; Material Twisted/Bent

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE ELECTRODE WAS ARTICULATING AND THE SCALPEL TIP COATING PART WAS PEELING OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518345 ↗
• MalfunctionJan 12, 2024Peeled/Delaminated; Material Twisted/Bent; Peeled/Delaminated; Material Twisted/Bent

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE ELECTRODE WAS ARTICULATING AND THE SCALPEL TIP COATING PART WAS PEELING OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18507524 ↗
• MalfunctionOct 3, 2023Melted; Peeled/Delaminated; Detachment of Device or Device Component; Melted; Peeled/Delaminated; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A NEURO PROCEDURE, THE INSULATED TIP OF THE DEVICE MELTED OFF INTO THE SURGICAL WOUND/PATIENT CAVITY. THE DISENGAGED PIECE WAS RETRIEVED, BUT NO ADDITIONAL MEDICAL PROCEDURE WAS NEEDED TO REMOVE THE PIECE FROM THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17865380 ↗
• InjuryAug 3, 2018Break; Material Fragmentation; Loose or Intermittent Connection; Peeled/Delaminated; Component Missing; Detachment of Device or Device Component; Peeled/Delaminated; Component Missing; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WAS FELT THE INSULATION WAS LOOSE. THE INSULATION BROKE IN PIECES WHILE USING, AND SOME OF THE PIECES CAME OFF. ONE OF THE FALLEN PIECES WAS MISSING AND COULD NOT BE FOUND AS IT FELL INTO PATIENT'S CAVITY AND COULD NOT BE RETRIEVED. ALSO THE PHYSICIAN TORE A PART OF THE INSULATION. THERE WAS NO PATIENT HARM. A PHOTO WAS SUBMITTED WITH MARKINGS AS ENCIRCLED 1 AND 2 INDICATE THE PIECES CAME OFF, AND ENCIRCLED 1 WENT MISSING, ENCIRCLED 3 INDICATES THE PIECE WAS TORN BY THE PHYSICIAN.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 7747171 ↗