Arthromatic/Uromatic 2C4040Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00085412001050), received between Feb 2, 2018 and Mar 19, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (10 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJan 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FIVE (5) CYSTO/BLADDER IRRIGATION SETS LEAKED FROM AN UNSPECIFIED LOCATION. THESE WERE OBSERVED 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 21208175 ↗
• MalfunctionDec 18, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PARTICULATE MATTER (PM) WAS DISCOVERED WITHIN THE STERILE PACKAGING OF A CYSTO/BLADDER IRRIGATION SET. THE PM WAS FURTHER DESCRIBED AS HAIR IN THE PACKAGE. 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 18352253 ↗
• MalfunctionNov 7, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER (PM) CONTAMINATION OBSERVED WITH A CYSTOSCOPY IRRIGATION SET. THE PM WAS FURTHER DESCRIBED AS A ¿BROWN SPEC (LOOKS LIKE A PIECE OF CARDBOARD)¿. THE ISSUE WAS IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18086679 ↗
• MalfunctionOct 16, 2023Disconnection; Incomplete or Inadequate Connection; Disconnection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT UNSPECIFIED QUANTITY OF CYSTO/BLADDER IRRIGATION SETS WOULD NOT CONNECT TO THE SCOPE. THE TUBING DIAMETER WAS NOT HOLDING. THIS WAS DISCOVERED DURING IVF TREATMENT. 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 17939788 ↗
• MalfunctionJun 21, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT REPORTED THAT THERE WAS HAIR IN THE TUBING OF A CYSTO/BLADDER IRRIGATION SET. THE ISSUE WAS IDENTIFIED DURING SET-UP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17173191 ↗
• MalfunctionNov 4, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PARTICULATE MATTER (PM) WAS OBSERVED WITHIN THE TUBING OF A CYSTO/BLADDER IRRIGATION SET. THE PM WAS FURTHER DESCRIBED AS DEBRIS INSIDE THE TUBING THAT APPEARED AS A BUG COOKED DURING STERILIZATION. THIS ISSUE WAS IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15737629 ↗
• MalfunctionOct 13, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CYSTO/BLADDER IRRIGATION SET LEAKED BETWEEN THE DRIP CHAMBER AND TUBE. THIS WAS OBSERVED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15595655 ↗
• MalfunctionJul 23, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SEVEN HUNDRED SIXTY-EIGHT (768) CYSTO/BLADDER IRRIGATION SETS HAD EMBEDDED PARTICULATE ON THE TUBING. THIS ISSUE WAS IDENTIFIED DURING SETUP AND PREPARATION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12217782 ↗
• MalfunctionMay 12, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PARTICULATES WERE OBSERVED IN THE TUBING OF ONE-HUNDRED-FIFTY-FIVE (155) CYSTO/BLADDER IRRIGATION SETS. THIS WAS OBSERVED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812358 ↗
• MalfunctionDec 29, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PARTICULATE MATTER (PM) WAS EMBEDDED WITHIN THE TUBING OF AN UNSPECIFIED QUANTITY OF CYSTO/BLADDER IRRIGATION SETS. THE PM WAS DISCOVERED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 11091605 ↗
• MalfunctionNov 13, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT RED FLECKS WERE OBSERVED TO BE EMBEDDED IN THE TUBING ON MULTIPLE AREAS OF A CYSTO/BLADDER IRRIGATION SET. THIS WAS IDENTIFIED PRIOR TO USE ON A PATIENT. THE SET WAS REMOVED FROM THE ROOM AND ANOTHER TUBING WAS OBTAINED FOR USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10839176 ↗
• MalfunctionNov 5, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT EMBEDDED PARTICULATE WAS DISCOVERED IN AN UNSPECIFIED QUANTITY OF CYSTO/BLADDER IRRIGATION SETS. THIS WAS IDENTIFIED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10792807 ↗
• MalfunctionApr 3, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A HAIR WAS DISCOVERED WITHIN THE PACKAGING OF A CYSTO/BLADDER IRRIGATION SET. THIS EVENT WAS DISCOVERED DURING AN UNSPECIFIED PROCESS STEP BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7394190 ↗
• MalfunctionFeb 2, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A LEAK FROM THE TUBING OF A CYSTOSCOPY IRRIGATION SET. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7237020 ↗

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-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
• 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