Arthromatic/UromaticRecalls & reported problems across all models
Baxter International Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 59
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 3 models of Arthromatic/Uromatic by Baxter International Inc. in the FDA's device registry (GUDID). Together they are named in 59 adverse event reports in the FDA's MAUDE database, received between Feb 2, 2018 and Sep 8, 2026 — classified as 59 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (23 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Arthromatic/Uromatic problems
Device problems
- Fluid/Blood Leak23
- Device Contamination with Chemical or Other Material16
- Disconnection3
- Tear, Rip or Hole in Device Packaging3
- Backflow2
- Break2
- Filling Problem2
- Material Split, Cut or Torn2
Patient problems
- No Clinical Signs, Symptoms or Conditions45
- No Patient Involvement8
- No Consequences Or Impact To Patient5
- Pain1
Arthromatic/Uromatic models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Arthromatic/Uromatic 2C4041System, irrigation, urological40 reports
- Arthromatic/Uromatic 2C4040ARTHROSCOPE15 reports
- Arthromatic/Uromatic 2C4005ARTHROSCOPE4 reports
Recent Arthromatic/Uromatic adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50674121 ↗MalfunctionApr 24, 2026Backflow; Free or Unrestricted Flow
IT WAS REPORTED THAT A Y-TYPE TUR/BLADDER IRRIGATION SET CLAMP WAS NOT HOLDING UNDER PRESSURE, RESULTING IN FLUID BACKFLOW INTO A SECOND MEDICINE BAG. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24988233 ↗MalfunctionFeb 9, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A Y-TYPE TUR/BLADDER IRRIGATION SET LEAKED NEAR THE Y-JUNCTION. THIS WAS OBSERVED DURING PRIMING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24299050 ↗MalfunctionFeb 4, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A Y-TYPE TUR/BLADDER IRRIGATION SET WAS LEAKING FROM AN UNSPECIFIED LOCATION. THE LEAK WAS OBSERVED WHILE PRIMING THE SET PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24263065 ↗MalfunctionFeb 3, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A Y-TYPE TUR/BLADDER IRRIGATION SET LEAKED FROM AN UNSPECIFIED LOCATION. THIS WAS OBSERVED DURING PRIMING. THE DEVICE CONTAINED SALINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24251168 ↗MalfunctionNov 4, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn
IT WAS REPORTED THAT THE TUBING OF A Y-TYPE TUR/BLADDER IRRIGATION SET WAS IN TWO PIECES AND LEAKED. THIS WAS OBSERVED DURING SETUP PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23469772 ↗MalfunctionOct 22, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THE SPIKE OF A Y-TYPE TUR/BLADDER IRRIGATION SET FELL OUT FROM A NON-BAXTER SALINE SOLUTION BAG. THIS WAS OBSERVED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23358471 ↗MalfunctionAug 25, 2025Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT THE STERILE PACKAGE OF A Y-TYPE TUR/BLADDER IRRIGATION SET WAS NOT SEALED PROPERLY. THE ISSUE WAS FURTHER DESCRIBED AS, "THE PLASTIC SLEEVE FOR PROTECTING TUR TUBING WAS PINCHED BY THE SEALING". THIS WAS DISCOVERED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22889528 ↗MalfunctionJul 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A Y-TYPE TUR/BLADDER IRRIGATION SET LEAKED FROM THE DRIP CYLINDER DURING OPERATION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22511490 ↗MalfunctionJun 9, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF Y-TYPE TUR/BLADDER IRRIGATION SETS LEAKED FROM AN UNSPECIFIED LOCATION. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22170253 ↗MalfunctionJun 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A Y-TYPE TUR/BLADDER IRRIGATION SET WAS LEAKING FROM THE TUBING AT THE Y SHAPED COMPONENT. THE LEAK WAS OBSERVED DURING PREPARATION AT THE HOSPITAL PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22135408 ↗MalfunctionMay 20, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE STERILE PACKAGE OF A Y-TYPE TUR IRRIGATION SET WAS NOT SEALED PROPERLY. THE ISSUE WAS FURTHER DESCRIBED AS, "THE RED CAP OF THE SPIKE WAS PINCHED BY SEALING". THE RED CAP WAS STICKING OUT OF THE PACKAGING. THIS OCCURRED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22055350 ↗MalfunctionMar 31, 2025Component Misassembled; Component Misassembled
IT WAS REPORTED THAT Y-TYPE TUR/BLADDER IRRIGATION SET WAS INCORRECTLY ASSEMBLED. THIS ISSUE WAS FURTHER DESCRIBED AS THE ¿CLAMP FALLING OFF¿. THIS ISSUE WAS OBSERVED AT THE HOSPITAL PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21733135 ↗MalfunctionMar 25, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PACKAGING OF A Y-TYPE TUR/BLADDER IRRIGATION SET HAD APPROXIMATELY A 1-2CM GAP AT THE UPPER SIDE OF THE POUCH SEAL; THE PACKAGE WAS PARTIALLY OPENED AND NOT SEALED PROPERLY. THIS WAS NOTICED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21691558 ↗MalfunctionMar 19, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AT LEAST THREE (3) (BETWEEN 3 AND SEVEN (7)) CYSTO/BLADDER IRRIGATION SETS LEAKED. THE LOCATION WAS FURTHER SPECIFIED AS LEAKING FROM WHERE "THE TUBING CONNECTED TO THE SPIKING PORT" OR WATER LEAKING FROM "THE BOTTOM OF THE DRIP CHAMBER WHERE THE TUBING CONNECTS TO THE DRIP CHAMBER"; THERE WAS NO MEDICATION LOSS. THIS OCCURRED DURING A HYSTEROSCOPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21645573 ↗
Other Baxter International Inc. products
- CLEARLINK/CONTINU-FLO12 models · 824 reports · 6 recalls
- ONE-LINK12 models · 638 reports · 1 recall
- CLEARLINK19 models · 359 reports · 4 recalls
- INTRAVIA7 models · 455 reports
- CLEARLINK/DUO-VENT3 models · 150 reports
- INTERLINK17 models · 129 reports
- LOW RECIRCULATION VOLUME APD SET2 models · 69 reports
- PrismaSATE2 models · 1 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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