FMS 283422Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886705025909), received between Nov 7, 2019 and Dec 16, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE CRVD ULT AGG BLADE 4.2MM DEVICE WOULD GET CLOGGED AND THE SHAVER MOTOR WAS STRAINING. IT WAS REPORTED THAT THE USER HAD TO USE ANOTHER BLADE DEVICE DURING THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23818427 ↗
• MalfunctionDec 9, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE CRVD ULT AGG BLADE 4.2MM DEVICE WOULD GET CLOGGED AND THE SHAVER MOTOR WAS STRAINING. IT WAS REPORTED THAT THE USER HAD TO USE ANOTHER BLADE DEVICE DURING THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757143 ↗
• MalfunctionMar 18, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING AN UNSPECIFIED AROTHROSCOPY PROCEDURE ON (B)(6) 2024 THE CRVD ULT AGG BLADE 4.2MM DEVICE HAVER SUCTION STOPPED IN THE BLADE DUE TO PLASTIC ( PROTECTION FOR THE INSIDE BLADE). THERE WAS A FIVE MINUTE DELAY IN THE PROCEDURE REPORTED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18921177 ↗
• MalfunctionJan 2, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2023 THE CRVD ULT AGG BLADE 4.2MM 5PK DEVICE BROKE WHILE INSERTING IT THROUGH AN ARTHROSCOPIC PORTAL WHICH WAS USED SEVERAL TIMES BEFORE. THE FORCE ACTING ON THE SHAVER BLADE WAS MINIMAL. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18427618 ↗
• MalfunctionJun 8, 2023Break; Break

  IT WAS REPORTED BY A FIELD SERVICE ENGINEER IN AUSTRALIA THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THERE WERE METAL SHAVINGS WHILE USING THE FMS CURVED ULTRA-AGGRESSIVE BLADE PLUS 4.2MM 5PK DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 10 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17088236 ↗
• MalfunctionApr 6, 2023Use of Device Problem; Infusion or Flow Problem; Use of Device Problem; Infusion or Flow Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN SWITZERLAND THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, A FMS CURVED ULTRA-AGGRESSIVE BLADE PLUS 4.2MM 5PK DEVICE WAS USED. ACCORDING TO THE REPORT, THE INNER PART OF THE SHAVER WAS COVERED WITH A PLASTIC LAYER; AND THEREFORE, THE SUCTION THROUGH THE SHAVER WAS NOT POSSIBLE. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16691399 ↗
• MalfunctionNov 7, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(4) AS FOLLOWS: IT WAS REPORTED THAT THE SHAVER BROKE INTRAOPERATIVELY ON (B)(6) 2019. IN ORDER TO GET THE SHAVER IN THE RIGHT ANGLE, HE HAD TO APPLY SOME PRESSURE. NO PARTS FELL INTO THE PATIENT. THE PROCEDURE WAS EXTENDED FOR ABOUT 2 MINUTES. NO PATIENT CONSEQUENCE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9291659 ↗