Arthromatic/Uromatic 2C4041Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00085412001067), received between Jul 3, 2018 and Sep 8, 2026 — classified as 40 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (19 reports).

4 other recalls cover devices cleared under the same FDA submission (K960787); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, 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 ↗
• 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 ↗
• MalfunctionJan 2, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT A Y-TYPE TUR/BLADDER IRRIGATION SET LEAKED FROM BOTTOM OF THE DRIP CHAMBER. THE ISSUE WAS FURTHER DESCRIBED AS, THE TUBING HAD A CRACK AND THE LIQUID IS LEAKING FROM THE PLASTIC CONNECTION PART. 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 21064070 ↗
• MalfunctionJan 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A Y-TYPE TUR/BLADDER IRRIGATION SET LEAKED FROM THE DRIP CHAMBER. THIS WAS OBSERVED DURING PATIENT INFUSION. 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 21063349 ↗
• MalfunctionDec 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A Y-TYPE TUR/BLADDER IRRIGATION SET LEAKED FROM THE DRIP CHAMBER. THIS WAS OBSERVED DURING PATIENT USE. 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 21028382 ↗
• MalfunctionOct 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ADAPTOR OF A Y-TYPE TUR/BLADDER IRRIGATION SET WAS SEPARATED FROM THE TUBING. THE SEPARATED SET WAS DISCOVERED IN THE POUCH PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20561881 ↗
• MalfunctionOct 14, 2024No Flow; No Flow

  IT WAS REPORTED SIX (06) Y-TYPE TUR/BLADDER IRRIGATION SETS WOULD NOT FLOW. WHEN THE NURSE WOULD CHANGE OUT THE IRRIGATION BAG, THE TUBE WOULD NOT DRIP FROM THE SECTION OF TUBE GOING TO THE Y-CONNECTOR, SO THEY HAD TO CHANGE OUT THE WHOLE IRRIGATION SET. THIS WAS OBSERVED DURING PATIENT USE. 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 20439976 ↗
• MalfunctionJun 3, 2024Break; Break

  IT WAS REPORTED THAT A Y-TYPE TUR/BLADDER IRRIGATION SET WAS "BROKEN". 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 19448325 ↗
• MalfunctionNov 7, 2023Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT A Y-TYPE TUR/BLADDER IRRIGATION SET HAD MOLD INSIDE THE TUBING. THIS WAS DISCOVERED 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 18086365 ↗
• MalfunctionAug 22, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DEBRIS WAS OBSERVED IN THE TUBING OF THREE (3) Y-TYPE TUR/BLADDER IRRIGATION SETS. THIS WAS IDENTIFIED AFTER OPENING THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17599546 ↗
• MalfunctionJul 6, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT TWO (2) Y-TYPE TUR/BLADDER IRRIGATION SETS HAD PARTICULATE MATTER INSIDE THE STERILE FLUID PATH. THIS ISSUE WAS IDENTIFIED DURING THE RELABELING OF PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17266490 ↗
• MalfunctionJun 29, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A Y-TYPE TUR/BLADDER IRRIGATION SET WAS DETECTED WITH PARTICULATE MATTER INSIDE THE STERILE FLUID PATH. THIS WAS DISCOVERED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17225433 ↗
• MalfunctionJun 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A Y-TYPE TUR/BLADDER IRRIGATION SET LEAKED SOMEWHERE BETWEEN THE ROLLER CLAMP AND DRIP CHAMBER. THIS ISSUE OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17171163 ↗
• MalfunctionJun 19, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A Y-TYPE TUR/BLADDER IRRIGATION SET LEAKED FROM AN UNSPECIFIED LOCATION. THIS WAS IDENTIFIED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17153453 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K960787. One submission often covers many models, so check the product and lot details in each record.

• Z-1010-2015 · Jan 14, 2015 · Terminated
  Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.2 m)
• Z-1683-2013 · May 15, 2013 · Terminated
  Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4030 - Approximate Length 98" (2.5. m) Usage: Baxter irrigation sets are intended
• Z-1682-2013 · May 15, 2013 · Terminated
  Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85" (2.2. m) Usage: Baxter irrigation sets are intended for the d
• Z-1684-2013 · May 15, 2013 · Terminated
  Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4031 -Approximate Length 99" (2.5. m) Usage: Baxter irrigation sets are intended