Arthrex® AR-12974NRRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867195721), received between Jan 12, 2024 and Feb 12, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2024Defective Device; Defective Device

  ON 01/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-12974NR MINI FIBERTAPE RETRIEVER WITH NR HANDLE HAS A DAMAGED WORKING TIP. THIS WAS DISCOVERED DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2024, WHERE THEY USED ANOTHER RETRIEVER TO COMPLETE THE CASE. THERE WAS NO ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18685203 ↗
• MalfunctionJan 12, 2024Break; Material Fragmentation; Break; Material Fragmentation

  ON 12/20/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE THAT AN AR-12974NR FIBERTAPE RETRIEVER BROKE AND GOT STUCK IN THE SHOULDER. PRODUCT WAS ABLE TO BE REMOVED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18502683 ↗