Arthrex® AR-3200-0027Recalls & reported problems
Arthrex, Inc. · CCU, SYNERGY VISION CONNECT · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867443778), received between Jun 11, 2024 and Mar 25, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Emits Odor” (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.
Reports received per month
Most reported problems
Device problems
- Device Emits Odor1
- Display or Visual Feedback Problem1
- Overheating of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2026Overheating of Device
ON 05-MAR-2026, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-3200-0027 SYNERGY VISION CONNECT CCU WAS OVERHEATING WITH THE SMELL OF BURNING PLASTIC FROM INSIDE THE UNIT. NO CASE WAS INVOLVED.
Patient problems: Insufficient Information
MAUDE report 24689926 ↗MalfunctionDec 3, 2025Device Emits Odor; Device Emits Odor
IT WAS REPORTED THAT THE CCU HAD A STRONG SMELL OF BURNT PLASTIC. THIS WAS NOTICED BEFORE USE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THERE WAS NO CASE INVOLVEMENT. NO FURTHER INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23707906 ↗MalfunctionJun 11, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT DURING AN ARTHROSCOPY ON THE RIGHT KNEE DIFFERENT ISSUES WITH THE CONSOLE HAVE OCCURRED. WHITE SPORADIC FLASHES WERE VISIBLE ON THE CAMERA IMAGE. THE CAMERA BUTTON OF THE NANO NEEDLE DID NOT WORK. NO IMAGES WERE VISIBLE ON THE TABLET. ( BLACK IMAGE AND NO EXPORT TO USB OR IPAD WAS POSSIBLE FOR A SPECIFIC CASE) AND THE HEADUP DISPLAY COULD NOT BE ACTIVATED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE 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 19514494 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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