Arthrex® AR-9803-90Recalls & reported problems
Arthrex, Inc. · COOLCUT 90, ABLATOR · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867062696), received between May 23, 2022 and May 23, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Melted” (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 18, 2026.
Most reported problems
Device problems
- Melted1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 23, 2022Melted
ON (B)(6) 2022, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA SEMS THAT A AR-9803-90 ABLATOR, AND A AR-4060S SUTURING SET MALFUNCTIONED. THIS OCCURRED ON (B)(6) 2022 DURING AN UNKNOWN PROCEDURE WHEN USING THE AR-9803-90 THE TIP MELTED INTO THE SHAPE OF A J, IT WAS USED AT A TEMPERATURE OF 60/60. WHEN USING THE PROTECTOR, THE DOCTOR HAD TO FORCE THE THREAD THROUGH AS IT WAS GETTING STUCK. THERE WAS NO PATIENT EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14469704 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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