CRYSTALVIEW CV4000Recalls & reported problems
Conmed Corporation · CRYSTALVIEW PRO IRRIGATION CONSOLE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30653405987509), received between Nov 22, 2024 and Nov 22, 2024 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Cardiac Arrest1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE CV4000, CRYSTALVIEW PRO IRRIGATION CONSOLE WAS USED ON (B)(6) 2024 AND ¿THEY EXPERIENCED A PATIENT GETTING INTO CARDIAC ARREST DURING ARTHROSCOPIC SHOULDER SURGERY. THEY WANTED US TO CONTROL/CALIBRATE THE PUMPS PRESSURE SETTINGS TO CLEAR THAT THE PUMP DIDN´T CAUSE ANY DAMAGE. I WENT TO THE CLINIC AND TALKED TO THE SURGEON & ANESTHESIOLOGIST AT 12.30 CET: THE PROCEDURE WAS DONE ON THE PATIENT¿S LEFT SIDE WITH THE PATIENT PLACED ON HIS STOMACH. CV4000 WAS SET TO A PRESSURE OF 50 MMHG. AFTER APPROXIMATELY 40 MINUTES THEY WERE WRAPPING UP THE SURGERY AND THAT¿S WHEN THE PATIENT WENT INTO CARDIAC ARREST. THEY PREFORMED CPR AND THE PATIENT WAS LATER TRANSPORTED TO HOSPITAL. THE PATIENT HAD NO KNOWN KIDNEY OR HEART DISEASE AND HAD NEVER UNDERGONE ANY SHOULDER- OR LUNG SURGERY.¿. FURTHER ASSESSMENT FOUND THERE WAS NO KNOWN DEVICE MALFUNCTION, AND THE USER DID NOT INDICATE THAT THE CV4000 DEVICE CAUSED THE PATIENT¿S CARDIAC ARREST, BUT "WANTS TO ELIMINATE ALL POSSIBLE FACTORS FOR THE INCIDENT AND WISHES TO HAVE THE PUMP SETTINGS CONTROLLED SO THEY KNOW THAT THE SET PRESSURE WAS WHAT IT WAS SET TO BE. THE PATIENT WAS DISCHARGED
Patient problems: Cardiac Arrest
MAUDE report 20758982 ↗
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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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