Arthrex® AR-3372-4002Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867198531), received between Jan 16, 2023 and Apr 15, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2026Break

  IT WAS REPORTED THAT DURING THE SHOULDER ARTHROSCOPY, THE SHEATH BROKE. NO FRAGMENTS REMAINED IN THE PATIENT´S BODY. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885600 ↗
• MalfunctionJul 3, 2025Break; Break

  ON 06/09/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3372-4002 SHEATH'S STOP COCK IS BROKEN. DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.

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

  MAUDE report 22395273 ↗
• MalfunctionJun 19, 2025Break; Break

  ON 05/28/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3372-4002 SHEATH'S STOPCOCK BROKE OFF. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289490 ↗
• MalfunctionMar 17, 2025Break; Break

  ON 02/27/2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT TWO (QTY.2) AR-3372-4002 STOPCOCK SHEATHS ARE BROKEN. THEY OCCURRED DURING A CASE WITH THE PATIENT UNAFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21618903 ↗
• MalfunctionMar 17, 2025Break; Break

  ON 02/27/2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA )B)(4) THAT TWO (QTY.2) AR-3372-4002 STOPCOCK SHEATHS ARE BROKEN. THEY OCCURRED DURING A CASE WITH THE PATIENT UNAFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21618758 ↗
• MalfunctionMar 12, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3372-4002 SHEATH STOP COCK BROKE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21582282 ↗
• MalfunctionFeb 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 1/18/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3372-4002 SHEATH STOPCOCK DISASSOCIATED FROM THE SHEATH AT THE WELDING POINT. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18651604 ↗
• MalfunctionJan 16, 2023Break

  ON 12/30/2022, A MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL THAT A SMALL PIECE OF THE OBTURATOR FROM AN AR-3372-4002 SCOPE SHEATH, BROKE OFF AND ENTERED THE PATIENT. THE SURGEON WAS ABLE TO REMOVE THE BROKEN FRAGMENT AND USED A NEW AR-3372-4002 SCOPE SHEATH TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(4) 2022. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 16173489 ↗