Medline ASC425001RHRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888277380066), received between Aug 13, 2018 and Aug 5, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2022Detachment of Device or Device Component; Device Fell

  ACCORDING TO THE FACILITY ON (B)(6) 2022 DURING THE MIDDLE OF A PROCEDURE ON THE PATIENT'S RIGHT SHOULDER 'THE BEAD ON THE END OF THE WAND FELL OFF INTO THE PATIENT AND HAD TO BE REMOVED WITH A GRASPER'.

  Patient problems: Foreign Body In Patient

  MAUDE report 15178229 ↗
• MalfunctionJul 19, 2021Break

  IT WAS REPORTED A PIECE BROKE OFF THE WAND AND WAS RETRIEVED BY THE PHYSICIAN WITH A GRASPER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12194151 ↗
• MalfunctionFeb 28, 2020Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE ABLATION ELECTRODE FELL OFF DURING USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9771379 ↗
• MalfunctionAug 13, 2018Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF A REPROCESSED ARTHROCARE WAND FELL APART INSIDE OF A PATIENT DURING USE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7777241 ↗