24K 24KTIPSRecalls & reported problems
Conmed Corporation · TUBE SET 24K TRUE INTRA-ARTICULAR PRESSURE SENSING · Class 2
Data updated Oct 16, 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 10845854041185), received between Apr 26, 2017 and Apr 26, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (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
Device problems
- Excess Flow or Over-Infusion1
- Increase in Pressure1
- Pressure Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 26, 2017Excess Flow or Over-Infusion; Increase in Pressure; Pressure Problem; Pressure Problem
THE USER FACILITY REPORTED THAT DURING USE OF THE 24KTIPS TRUE INTRA-ARTICULAR PRESSURE SENSING TUBING SET IN A SHOULDER ARTHROSCOPY, THE 24K PUMP DID NOT SEEM TO BE REGULATING PRESSURE PROPERLY. THE REPORT FURTHER STATED THAT THE ISSUE SEEMED TO BE RELATED TO PRESSURE SENSING FROM 24KTIPS AND "IT RESULTED IN A DANGEROUS INFLUX OF FLUID AND PRESSURE INTO THE SHOULDER JOINT SPACE". AFTER SOME TROUBLE SHOOTING, THE SURGICAL STAFF IDENTIFIED THAT THE PROBLEM WAS RELATED TO THE 24KTIPS AND THIS SPECIFIC LOT NUMBER. AS REPORTED, THE PROCEDURE WAS COMPLETED AS PLANNED WITH THE USE OF ANOTHER 24KTIPS WITH A DIFFERENT LOT NUMBER. THERE WAS NO REPORT OF ABNORMAL SWELLING OR EXTRAVASATION OCCURRED. IN ADDITION, FOLLOW-UP WITH THE USER FACILITY CONFIRMED THAT THERE WAS NO ADDITIONAL SURGICAL OR MEDICAL INTERVENTION REQUIRED AND THE PROCEDURE WAS OTHERWISE COMPLETED WITH NO PATIENT INJURY WITH THIS REPORTED ISSUE. THIS REPORT IS FILED ON THE BASIC OF POTENTIAL FOR PATIENT INJURY WITH RECURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6522964 ↗
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- MITEK 242018Medos International Sàrl · Arthroscope731 reports
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- FMS VUE II 284004Medos International Sàrl · Arthroscope562 reports
- VAPR COOLPULSE 228146Depuy Mitek, LLC · ARTHROSCOPE474 reports
- FMS DUO 284580Depuy Mitek, LLC · ARTHROSCOPE458 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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