FlowArt® A1010H-SRecalls & reported problems
Asset Medikal Tasarim Sanayi Ve Ticaret Anonim Sirketi · Needle-Free Split Septum Valve, Single, Hemodialysis · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08699443580044), received between Sep 17, 2024 and Sep 17, 2024 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (6 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, 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Connection Problem6
- Incomplete or Inadequate Connection1
Patient problems
- Hemorrhage/Blood Loss/Bleeding6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2024Connection Problem; Connection Problem
SIX (6) SEPARATE EVENTS HAVE OCCURRED SINCE (B)(6) 2024 WHERE THE DIALYSIS BLOOD LINE BECOMES DISCONNECTED FROM THE FLOWART NEEDLE-FREE SPLIT SEPTUM VALVE WHILE THE PATIENT IS RECEIVING A DIALYSIS TREATMENT. THIS HAS RESULTED IN THE LOSS OF BLOOD ON SEVERAL OF THESE OCCASIONS. THE DISTRIBUTER/MANUFACTURER HAS BEEN NOTIFIED OF EACH EVENT. REFERENCE REPORTS: MW5158285, MW5158286, MW5158287, MW5158288, MW5158289. DURING A ROUTINE DIALYSIS TREATMENT, A NURSE WAS SWABBING THE A1010H-S VALVE WITH ALCOHOL, PER PROCEDURE, WHEN THE VALVE BECAME DISCONNECTED FROM THE BLOOD LINE. THE BLOOD LINE WAS NOT INTENDED TO BE DISCONNECTED AND THE VALVE WAS NOT MANIPULATED IN A MANNER THAT WOULD OTHERWISE RESULT IN A DISCONNECTION. THE A1010H-S VALVE SEEMED TO NOT HAVE BEEN THREADED ONTO THE BLOOD LINE CORRECTLY. THE NURSE WAS EXPERIENCED AND HAS PERFORMED THIS ACTION MANY TIMES WITHOUT A SUDDEN DISCONNECTION OF THE VALVE FROM THE BLOOD LINE. STAFF AT THIS DIALYSIS CENTER HAVE REPORTED THAT THE THREADS OF THE VALVE SOMETIMES CAN BE VERY DIFFICULT TO CONNECT TO SYRINGES OR BLOOD LINES. THEY HAVE NOT REPORTED ISSUES CONNECTING THE VALVE TO THE PATIENT DIALYSIS CATHETER. BASED ON THE DIFFICULTY OF THREADI
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20238442 ↗MalfunctionSep 17, 2024Connection Problem; Connection Problem
SIX (6) SEPARATE EVENTS HAVE OCCURRED SINCE MAY 2ND, 2024 WHERE THE DIALYSIS BLOOD LINE BECOMES DISCONNECTED FROM THE FLOWART NEEDLE-FREE SPLIT SEPTUM VALVE WHILE THE PATIENT IS RECEIVING A DIALYSIS TREATMENT. THIS HAS RESULTED IN THE LOSS OF BLOOD ON SEVERAL OF THESE OCCASIONS. THE DISTRIBUTER/MANUFACTURER HAS BEEN NOTIFIED OF EACH EVENT. REFERENCE REPORTS: MW5158285, MW5158286, MW5158287, MW5158288, MW5158289. DURING A ROUTINE DIALYSIS TREATMENT, A NURSE WAS SWABBING THE A1010H-S VALVE WITH ALCOHOL, PER PROCEDURE, WHEN THE VALVE BECAME DISCONNECTED FROM THE BLOOD LINE. THE BLOOD LINE WAS NOT INTENDED TO BE DISCONNECTED AND THE VALVE WAS NOT MANIPULATED IN A MANNER THAT WOULD OTHERWISE RESULT IN A DISCONNECTION. THE A1010H-S VALVE SEEMED TO NOT HAVE BEEN THREADED ONTO THE BLOOD LINE CORRECTLY. THE NURSE WAS EXPERIENCED AND HAS PERFORMED THIS ACTION MANY TIMES WITHOUT A SUDDEN DISCONNECTION OF THE VALVE FROM THE BLOOD LINE. STAFF AT THIS DIALYSIS CENTER HAVE REPORTED THAT THE THREADS OF THE VALVE SOMETIMES CAN BE VERY DIFFICULT TO CONNECT TO SYRINGES OR BLOOD LINES. THEY HAVE NOT REPORTED ISSUES CONNECTING THE VALVE TO THE PATIENT DIALYSIS CATHETER. BASED ON THE DIFFICULTY OF THREA
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20238440 ↗MalfunctionSep 17, 2024Connection Problem; Connection Problem
SIX (6) SEPARATE EVENTS HAVE OCCURRED SINCE MAY 2ND, 2024 WHERE THE DIALYSIS BLOOD LINE BECOMES DISCONNECTED FROM THE FLOWART NEEDLE-FREE SPLIT SEPTUM VALVE WHILE THE PATIENT IS RECEIVING A DIALYSIS TREATMENT. THIS HAS RESULTED IN THE LOSS OF BLOOD ON SEVERAL OF THESE OCCASIONS. THE DISTRIBUTER/MANUFACTURER HAS BEEN NOTIFIED OF EACH EVENT. REFERENCE REPORTS: MW5158285, MW5158286, MW5158287, MW5158288, MW5158289. DURING A ROUTINE DIALYSIS TREATMENT, A NURSE WAS SWABBING THE A1010H-S VALVE WITH ALCOHOL, PER PROCEDURE, WHEN THE VALVE BECAME DISCONNECTED FROM THE BLOOD LINE. THE BLOOD LINE WAS NOT INTENDED TO BE DISCONNECTED AND THE VALVE WAS NOT MANIPULATED IN A MANNER THAT WOULD OTHERWISE RESULT IN A DISCONNECTION. THE A1010H-S VALVE SEEMED TO NOT HAVE BEEN THREADED ONTO THE BLOOD LINE CORRECTLY. THE NURSE WAS EXPERIENCED AND HAS PERFORMED THIS ACTION MANY TIMES WITHOUT A SUDDEN DISCONNECTION OF THE VALVE FROM THE BLOOD LINE. STAFF AT THIS DIALYSIS CENTER HAVE REPORTED THAT THE THREADS OF THE VALVE SOMETIMES CAN BE VERY DIFFICULT TO CONNECT TO SYRINGES OR BLOOD LINES. THEY HAVE NOT REPORTED ISSUES CONNECTING THE VALVE TO THE PATIENT DIALYSIS CATHETER. BASED ON THE DIFFICULTY OF THREA
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20238436 ↗MalfunctionSep 17, 2024Connection Problem; Connection Problem
SIX (6) SEPARATE EVENTS HAVE OCCURRED SINCE MAY 2ND, 2024 WHERE THE DIALYSIS BLOOD LINE BECOMES DISCONNECTED FROM THE FLOWART NEEDLE-FREE SPLIT SEPTUM VALVE WHILE THE PATIENT IS RECEIVING A DIALYSIS TREATMENT. THIS HAS RESULTED IN THE LOSS OF BLOOD ON SEVERAL OF THESE OCCASIONS. THE DISTRIBUTER/MANUFACTURER HAS BEEN NOTIFIED OF EACH EVENT. REFERENCE REPORTS: MW5158285, MW5158286, MW5158287, MW5158288, MW5158289. DURING A ROUTINE DIALYSIS TREATMENT, A NURSE WAS SWABBING THE A1010H-S VALVE WITH ALCOHOL, PER PROCEDURE, WHEN THE VALVE BECAME DISCONNECTED FROM THE BLOOD LINE. THE BLOOD LINE WAS NOT INTENDED TO BE DISCONNECTED AND THE VALVE WAS NOT MANIPULATED IN A MANNER THAT WOULD OTHERWISE RESULT IN A DISCONNECTION. THE A1010H-S VALVE SEEMED TO NOT HAVE BEEN THREADED ONTO THE BLOOD LINE CORRECTLY. THE NURSE WAS EXPERIENCED AND HAS PERFORMED THIS ACTION MANY TIMES WITHOUT A SUDDEN DISCONNECTION OF THE VALVE FROM THE BLOOD LINE. STAFF AT THIS DIALYSIS CENTER HAVE REPORTED THAT THE THREADS OF THE VALVE SOMETIMES CAN BE VERY DIFFICULT TO CONNECT TO SYRINGES OR BLOOD LINES. THEY HAVE NOT REPORTED ISSUES CONNECTING THE VALVE TO THE PATIENT DIALYSIS CATHETER. BASED ON THE DIFFICULTY OF THREA
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20238422 ↗MalfunctionSep 17, 2024Connection Problem; Incomplete or Inadequate Connection; Connection Problem; Incomplete or Inadequate Connection
SIX (6) SEPARATE EVENTS HAVE OCCURRED SINCE MAY 2ND, 2024 WHERE THE DIALYSIS BLOOD LINE BECOMES DISCONNECTED FROM THE FLOWART NEEDLE-FREE SPLIT SEPTUM VALVE WHILE THE PATIENT IS RECEIVING A DIALYSIS TREATMENT. THIS HAS RESULTED IN THE LOSS OF BLOOD ON SEVERAL OF THESE OCCASIONS. THE DISTRIBUTER/MANUFACTURER HAS BEEN NOTIFIED OF EACH EVENT. REFERENCE REPORTS: MW5158285, MW5158286, MW5158287, MW5158288, MW5158289. DURING A ROUTINE DIALYSIS TREATMENT, A NURSE WAS SWABBING THE A1010H-S VALVE WITH ALCOHOL, PER PROCEDURE, WHEN THE VALVE BECAME DISCONNECTED FROM THE BLOOD LINE. THE BLOOD LINE WAS NOT INTENDED TO BE DISCONNECTED AND THE VALVE WAS NOT MANIPULATED IN A MANNER THAT WOULD OTHERWISE RESULT IN A DISCONNECTION. THE A1010H-S VALVE SEEMED TO NOT HAVE BEEN THREADED ONTO THE BLOOD LINE CORRECTLY. THE NURSE WAS EXPERIENCED AND HAS PERFORMED THIS ACTION MANY TIMES WITHOUT A SUDDEN DISCONNECTION OF THE VALVE FROM THE BLOOD LINE. STAFF AT THIS DIALYSIS CENTER HAVE REPORTED THAT THE THREADS OF THE VALVE SOMETIMES CAN BE VERY DIFFICULT TO CONNECT TO SYRINGES OR BLOOD LINES. THEY HAVE NOT REPORTED ISSUES CONNECTING THE VALVE TO THE PATIENT DIALYSIS CATHETER. BASED ON THE DIFFICULTY OF THREA
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20238419 ↗MalfunctionSep 17, 2024Connection Problem; Connection Problem
SIX (6) SEPARATE EVENTS HAVE OCCURRED SINCE MAY 2ND, 2024 WHERE THE DIALYSIS BLOOD LINE BECOMES DISCONNECTED FROM THE FLOWART NEEDLE-FREE SPLIT SEPTUM VALVE WHILE THE PATIENT IS RECEIVING A DIALYSIS TREATMENT. THIS HAS RESULTED IN THE LOSS OF BLOOD ON SEVERAL OF THESE OCCASIONS. THE DISTRIBUTER/MANUFACTURER HAS BEEN NOTIFIED OF EACH EVENT. REFERENCE REPORTS: MW5158285, MW5158286, MW5158287, MW5158288, MW5158289. DURING A ROUTINE DIALYSIS TREATMENT, A NURSE WAS SWABBING THE A1010H-S VALVE WITH ALCOHOL, PER PROCEDURE, WHEN THE VALVE BECAME DISCONNECTED FROM THE BLOOD LINE. THE BLOOD LINE WAS NOT INTENDED TO BE DISCONNECTED AND THE VALVE WAS NOT MANIPULATED IN A MANNER THAT WOULD OTHERWISE RESULT IN A DISCONNECTION. THE A1010H-S VALVE SEEMED TO NOT HAVE BEEN THREADED ONTO THE BLOOD LINE CORRECTLY. THE NURSE WAS EXPERIENCED AND HAS PERFORMED THIS ACTION MANY TIMES WITHOUT A SUDDEN DISCONNECTION OF THE VALVE FROM THE BLOOD LINE. STAFF AT THIS DIALYSIS CENTER HAVE REPORTED THAT THE THREADS OF THE VALVE SOMETIMES CAN BE VERY DIFFICULT TO CONNECT TO SYRINGES OR BLOOD LINES. THEY HAVE NOT REPORTED ISSUES CONNECTING THE VALVE TO THE PATIENT DIALYSIS CATHETER. BASED ON THE DIFFICULTY OF THREA
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20238412 ↗
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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page