Medline PAD9165Recalls & reported problems

Summary

The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 10193489082531), received between Dec 1, 2022 and Sep 30, 2026 — classified as 10 injuries, 91 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 25 most recent of 101 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Electrical Shorting

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950823 ↗
• MalfunctionSep 30, 2026Break; Adhesive Too Strong

  It was reported that "There have been several instances noted of skin irritation to the patients. Also, another instance where it rips because the adhesive is too sticky."

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 50946637 ↗
• MalfunctionSep 30, 2026Device Fell

  It was reported that "Pads aren¿t sticking to patients. Falling off."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946584 ↗
• MalfunctionSep 30, 2026Detachment of Device or Device Component

  It was reported that THE PRODUCT EITHER DID NOT WORK OR THE PLUG END COMES APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945370 ↗
• MalfunctionSep 30, 2026Loss of or Failure to Bond

  It was reported that "ADHESIVE NOT STICKING WELL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944085 ↗
• MalfunctionSep 29, 2026Break

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 50938714 ↗
• MalfunctionSep 29, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937743 ↗
• MalfunctionSep 29, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937344 ↗
• MalfunctionSep 29, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933655 ↗
• MalfunctionSep 29, 2026Loss of or Failure to Bond

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933328 ↗
• MalfunctionSep 29, 2026Loss of or Failure to Bond

  It was reported that "Recently there was an issue with a few lots having adhesive issues" and that "Cambridge Sequestered the ones that are having the adhesion issue total (8) and Caulk Lane ASC did the same totaling (20)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933013 ↗
• MalfunctionSep 29, 2026Break; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932558 ↗
• MalfunctionSep 29, 2026Loss of or Failure to Bond

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932338 ↗
• MalfunctionSep 29, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932244 ↗
• MalfunctionSep 28, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917700 ↗
• MalfunctionSep 28, 2026Fitting Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916032 ↗
• MalfunctionSep 25, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50904284 ↗
• MalfunctionSep 25, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903454 ↗
• MalfunctionSep 25, 2026Energy Output Problem; Component or Accessory Incompatibility

  It was reported that "The past couple weeks my ortho surgeon has complained about his cautery not working- no heat to the pencil. The only variance we could identify was the ground pad. Suspecting it¿s the ground pad."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898403 ↗
• MalfunctionSep 25, 2026Loss of or Failure to Bond

  It was reported that the grounding pads were "NOT STICKING AND HAD TO BE CHANGED DURING PROCEDURES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896939 ↗
• MalfunctionSep 24, 2026Break

  It was reported that "THE PLASTIC WHERE THE WIRES ARE CONNECTING ARE BREAKING OFF MAKING THE PRODUCT UNUSABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884387 ↗
• MalfunctionSep 24, 2026Electrical /Electronic Property Problem

  It was reported that "When we plugged the grounding pad into the cautery machine, our machine was not able to register the grounding pad." "Pad was not being recognized when applied to a patient."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882992 ↗
• MalfunctionSep 23, 2026Loose or Intermittent Connection

  It was reported that apparently the connector is coming loose and preventing the ground pad to be effectively plugged in.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868692 ↗
• MalfunctionSep 23, 2026Break

  It was reported that "Skin irritant x4, attachment breaking from sticking= multiple times."

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 50866510 ↗
• MalfunctionSep 22, 2026Break

  It was reported that "Skin irritant x4, attachment breaking from sticking= multiple times."

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 50855317 ↗