Arthrex® AR-400UBCRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867246355), received between Mar 21, 2022 and May 23, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Emits Odor” (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.

• MalfunctionMay 23, 2024Device Emits Odor; Device Emits Odor

  IT WAS REPORTED THAT DURING THE CHARGING PROCESS SMOKE WAS EMITTED FROM THE DEVICE AND THERE WAS A SMELL OF BURNING. THE DEVICE WAS NOT LOCATED IN A SURGERY ROOM. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE 29-JUN-2022 IT WAS CONFIRMED THAT A BURNING SMELL WAS NOTICED BUT NO SMOKE WAS SEEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19382721 ↗
• MalfunctionMar 21, 2022Fire

  ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-400UBC BATTERY CHARGER AND AR-400UB BATTERY CAUGHT ON FIRE AND MELTED THE CONSOLE.

  Patient problems: Insufficient Information

  MAUDE report 13839551 ↗