NA 2C6204Recalls & reported problems
Baxter International Inc. · Large Bore Stopcock with Rotating Male Luer Lock · Class 2
Quick summary
This Baxter large bore stopcock is a rotating luer lock valve used to control fluid flow through IV lines and catheters. Most reports describe fluid or blood leaking from the connection, or the stopcock not allowing fluids and medications to flow through at all; a few mention cracked parts and packaging that was not sealed or sterile. There are 31 reports, with 1 injury and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00085412001913), received between Jan 28, 2019 and Sep 11, 2026 — classified as 1 injury, 31 malfunctions.
The most frequently reported specific device problem is “No Flow” (12 reports).
1 other recall cover devices cleared under the same FDA submission (K130245); 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.
Reports received per month
Most reported problems
Device problems
- No Flow12
- Fluid/Blood Leak10
- Delivered as Unsterile Product6
- Crack3
- Unsealed Device Packaging3
- Air/Gas in Device2
- Backflow2
- Contamination1
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- No Known Impact Or Consequence To Patient2
- Low Blood Pressure/ Hypotension1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50736930 ↗MalfunctionAug 13, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50242041 ↗MalfunctionFeb 24, 2026No Flow
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF LARGE BORE STOPCOCKS DID NOT CREATE A CONTINUOUS FLUID PATH WHEN CONNECTED WITH UNSPECIFIED IV EXTENSION SETS WITH NEEDLELESS ADAPTERS. THE ISSUE WAS OBSERVED WHEN TRYING TO ADMINISTER MEDICATION. WHEN CONNECTED AND OPENED, THERE WAS AN INABILITY TO FLUSH THE STOPCOCKS. 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 24432372 ↗MalfunctionFeb 24, 2026No Flow
IT WAS REPORTED THAT A LARGE BORE STOPCOCK WAS UNABLE TO INFUSE THROUGH CARDIOACTIVE MEDICATION AND "WAS IN PLACE ON A LINE THAT WAS SALINE LOCKED". THE ISSUE WAS NOTICED 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 24430271 ↗MalfunctionFeb 24, 2026No Flow
IT WAS REPORTED THAT MULTIPLE UNITS OF LARGE BORE STOPCOCKS WERE UNABLE TO INFUSE. THIS OCCURRED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24429695 ↗MalfunctionNov 19, 2025No Flow; No Flow
IT WAS REPORTED THAT A LARGE BORE STOPCOCK DID NOT INFUSE THE SALINE FLUSH TO THE UNSPECIFIED IV. THIS WAS OBSERVED DURING AN ECHOCARDIOGRAM WITH BUBBLE STUDY. 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 23599663 ↗MalfunctionMay 6, 2024Fluid/Blood Leak; Incomplete or Inadequate Connection; Fluid/Blood Leak; Incomplete or Inadequate Connection
IT WAS REPORTED THAT THREE (3) LARGE BORE STOPCOCKS WITH ROTATING MALE LUER LOCK WERE UNABLE TO BE CONNECTED TO THE TUBING (CATHETER THAT IS IN THE PATIENT) WHICH RESULTED IN FLUID LEAKING. THE STOPCOCKS WERE USED TO IRRIGATE THE NEPHROSTOMY CATHETER; HOWEVER, THE STOPCOCKS WOULD NOT CONNECT PROPERLY, AND URINE WOULD LEAK. THESE ISSUES WERE DESCRIBED AS, ¿ALTHOUGH ALL THE FAUCETS WERE SCREWED ON, THE URINE FLOWED THROUGH THE PART THAT SCREWED ON. AS IF IT WAS NOT WATERPROOF¿. 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 19255756 ↗MalfunctionMar 18, 2024Difficult to Flush; Difficult to Flush
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF LARGE BORE STOPCOCKS HAVE BEEN UNABLE TO FLUSH APPROPRIATELY. THIS OCCURRED DURING A BUBBLE TEST, PRIOR TO PATIENT USE. THERE WAS RESISTANCE WHEN ATTEMPTING TO FLUSH THROUGH THE DEVICES. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18926141 ↗MalfunctionFeb 15, 2024Backflow; Fluid/Blood Leak; Backflow; Fluid/Blood Leak
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF LARGE BORE STOPCOCKS LEAKED FROM AN UNSPECIFIED LOCATION; THERE WAS A CONCERN OF DRAWING BACK BLOOD. THIS WAS OBSERVED DURING USE OF THE DEVICES. 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 18717411 ↗MalfunctionFeb 15, 2024Backflow; Fluid/Blood Leak; Backflow; Fluid/Blood Leak
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF LARGE BORE STOPCOCKS LEAKED FROM AN UNSPECIFIED LOCATION; THERE WAS A CONCERN OF DRAWING BACK BLOOD. THIS WAS OBSERVED DURING USE OF THE DEVICES. 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 18717312 ↗MalfunctionFeb 6, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK DREW BACK BLOOD AND LEAKED. 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 18651623 ↗MalfunctionJan 23, 2024Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT AIR WAS OBSERVED IN A LINE DURING USE OF A LARGE BORE STOPCOCK. THE STOPCOCK WAS USED FOR A LAB DRAW OFF OF AN UMBILICAL ARTERY CATHETER (UAC). A DRAW WAS PERFORMED FROM THE LINE WITHOUT THE STOPCOCK ATTACHED WITH NO ISSUES NOTED. 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 18565641 ↗MalfunctionJan 22, 2024No Flow; No Flow
IT WAS REPORTED THAT A LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK WAS UNABLE TO DRAW BLOOD THROUGH THE SET. BLOOD WAS UNABLE TO BE DRAWN FROM A PERIPHERALLY INSERTED CENTRAL CATHETER LINE TO THE STOPCOCK. ONCE THE SYRINGE WAS PLACED DIRECTLY ON THE LINE, THE BLOOD DREW EASILY. 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 18558582 ↗MalfunctionJan 22, 2024No Flow; No Flow
IT WAS REPORTED THAT A CUSTOMER WAS UNABLE TO DRAW BLOOD THROUGH A LARGE BORE STOPCOCK. 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 18558090 ↗MalfunctionJan 22, 2024No Flow; No Flow
IT WAS REPORTED THAT A CUSTOMER WAS UNABLE TO DRAW BLOOD THROUGH A LARGE BORE STOPCOCK. 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 18557968 ↗MalfunctionJan 22, 2024No Flow; No Flow
IT WAS REPORTED THAT A CUSTOMER WAS UNABLE TO DRAW BLOOD THROUGH A LARGE BORE STOPCOCK. 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 18557965 ↗MalfunctionJan 19, 2024No Flow; Air/Gas in Device; No Flow; Air/Gas in Device
IT WAS REPORTED THAT A LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK DREW AIR INTO THE WASTE SYRINGE. THE BLOOD WAS NOT FREE FLOWING THROUGH THE LINE. THIS OCCURRED WHEN DRAWING LABS FROM THE PATIENT. 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 18543548 ↗MalfunctionJan 30, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A LARGE BORE STOPCOCK LEAKED FROM THE ROTATING MALE LUER LOCK END. 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 16269017 ↗MalfunctionDec 2, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE STOPCOCK OF THE UNSPECIFIED QUANTITY OF LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCKS WERE CRACKED WHICH RESULTED IN LEAKAGE OF UNSPECIFIED MEDICATION. 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 15904783 ↗MalfunctionDec 1, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF LARGE BORE STOPCOCKS CRACKED LEADING TO AN UNSPECIFIED MEDICATION LEAK. THE ISSUE WAS IDENTIFIED 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 15898888 ↗MalfunctionJul 30, 2021No Flow; No Flow
IT WAS REPORTED A LARGE BORE STOPCOCK WOULD NOT FLOW; FURTHER DESCRIBED AS THE STOPCOCK DID NOT LET SALINE FLOW IN THE LINE. IT WAS FURTHER STATED THAT THE IV WAS UNABLE TO BE FLUSHED THROUGH THE SIDEARM OF THE STOPCOCK. THIS ISSUE WAS IDENTIFIED DURING PATIENT INFUSION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12253238 ↗MalfunctionJul 2, 2021Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE PACKAGING OF (3) LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK WERE DEFECTIVE AND UNSTERILE WITH AIR LEAK. 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 12110788 ↗MalfunctionJul 2, 2021Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE PACKAGING OF THREE (3) LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK WERE DEFECTIVE AND UNSTERILE WITH AIR LEAK. 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 12110765 ↗MalfunctionJul 2, 2021Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE PACKAGING OF (8) LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK WERE DEFECTIVE AND UNSTERILE WITH AIR LEAK. 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 12110654 ↗MalfunctionJun 29, 2021Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging
IT WAS REPORTED THAT THREE (3) LARGE BORE STOPCOCKS WERE DEFECTIVE. THE DEFECT WAS FURTHER DESCRIBED AS PACKAGING WERE NOT STERILE, AIR LEAK FROM THE SIDE OF THE SEALED EDGE. THIS ISSUE WAS IDENTIFIED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12084988 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K130245. One submission often covers many models, so check the product and lot details in each record.
- Z-0189-2026 · Aug 29, 2025 · Open, ClassifiedCONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer Activated Valve, Pfoduct code
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.