SIROS D-Vial Prep Set SIR-10200Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00850014612016), received between Aug 22, 2025 and Aug 18, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (3 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.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50304824 ↗
• MalfunctionMay 26, 2026Air/Gas in Device

  A COMPLAINT WAS RECEIVED STATING MULTIPLE OCCASIONS OF AIR BEING INTRODUCED TO THE DELIVERY SET VIA THE PREPARED DOSE FROM THE D-VIAL. THE DOSE IS PREPARED BY A THIRD PARTY PHARMACY WHICH IS THEN PROVIDED TO THE HOSPITAL. THE HOSPITAL USED A SYRINGE TO REMOVE THE AIR BUBBLE AND BECAME RADIOACTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25279018 ↗
• MalfunctionApr 23, 2026Air/Gas in Device

  A COMPLAINT WAS RECEIVED STATING MULTIPLE OCCASIONS OF AIR BEING INTRODUCED TO THE DELIVERY SET VIA THE PREPARED DOSE FROM THE D-VIAL. THE DOSE IS PREPARED BY A THIRD PARTY PHARMACY WHICH IS THEN PROVIDED TO THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24967087 ↗
• MalfunctionJan 9, 2026Emergency Power Failure

  DURING THE DOSE DELIVERY, A LEAK WAS OBSERVED FROM THE D-VIAL. THREE ALIQUOTS OF THE DOSE WERE ATTEMPTED AND THE PATIENT RECEIVED ~65% OF THE DOSE. THE LEAK WAS CONTAINED WITHIN THE D-VIAL HOLDER AND NO CONTAMINATION OCCURRED. THE PHARMACY WAS CALLED AND PROVIDED A SECOND DOSE AND THE SECOND DELIVERY WAS ACHIEVED WITH NO FURTHER INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24022841 ↗
• MalfunctionOct 24, 2025Air/Gas in Device; Air/Gas in Device

  A THIRD-PARTY PHARMACY WAS USED TO PREPARE THE DOSE FOR THE HOSPITAL. THE HOSPITAL HAS STATED THEY EXPERIENCED TWO INCIDENCES OF AIR COMING OUT OF THE C LINE OFF THE D-VIAL DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23380761 ↗
• MalfunctionAug 22, 2025Complete Blockage; Complete Blockage

  THE HOSPITAL HAD A Y90 PROCEDURE FOR A REPEAT PATIENT. THE DOSE WAS DRAWN AND DELIVERED BY JUBILANT RADIO PHARMA. WHEN THE TIME CAME FOR THE ADMINISTRATION, THE SIROS DELIVERY SYSTEM WAS SET UP AND THE DELIVERY SET WAS FLUSHED WITH D5W. ONCE THE LINES WERE FLUSHED, WE CONNECTED THE A LINE TO THE MICRO CATHER WITH A WET-TO-WET CONNECTION AND THEN PROCEEDED TO CHECK ON THE MICROCATHETER POSITION UNDER FLUOROSCOPY. AT THAT TIME, THE DOCTOR ASKED TO HAVE THE D-VIAL PLACED INTO THE SIROS DELIVERY SYSTEM AND THE D LINE WAS DISCONNECTED FROM THE RED CONNECTOR AND MARRIED TO THE D PIGTAIL FROM THE VIAL AND THEN THE C LINE PIGTAIL WAS CONNECTED TO THE C PIGTAIL ON THE D-VIAL COMPLETING THE SYSTEM. ONCE THE SYSTEM WAS COMPLETED, WE RECHECKED THE CATHETER POSITIONING AND THEN PROCEEDED TO ADMINISTRATION. USING A 20CC SYRINGE - THE DOCTOR BEGAN ADMINISTRATION AND AT FIRST THE DOSE STARTED TO AGITATE IN THE VIAL AND AS WE WATCHED WE DID NOT SEE MICROSPHERES LEAVING THE VIAL THROUGH THE C LINE. THE DOCTOR COMMENTED THAT HE WAS HAVING TROUBLE PUSHING THE SYRINGE AND WAS GETTING PRESSURE. THE DOCTOR TRIED TO PUSH A FEW MORE TIMES AND THERE WAS NO VISIBLE DOSE MOVING INTO THE C LINE FROM THE DOSE V

  Patient problems: Insufficient Information

  MAUDE report 22873962 ↗
• MalfunctionAug 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THE VALVE WHICH CONNECTS TO THE C-LINE FROM THE D-VIAL DISCONNECTED DURING THE FIRST ALIQUOT OF SIR-SPHERES ADMINISTRATION. THE TUBING DID NOT RUPTURE, IT SIMPLY DISCONNECTED FROM THE VALVE ON THE C-LINE COMING OFF THE D-VIAL. THE C TO C CONNECTION REMAINED IN TACT. THIS RESULTED IN A SPILL WITHIN THE SIROS DELIVERY DOME. THE SPILL WAS CONTAINED BUT THIS WAS A FAILURE OF THE C LINE VALVE AND C LINE TUBING OF THE D-VIAL PREP SET. THE DOSE WAS UNABLE TO BE ADMINISTERED. DURING THE SCHEDULED OPERATION, NUCLEAR MEDICINE PREPARED ANOTHER DOSE, PATIENT RECEIVED APPROPRIATE PRESCRIBED DOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22873685 ↗
• MalfunctionAug 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THE VALVE ON THE D-VIAL D-LINE WAS NOT CORRECTLY GLUED INTO PLACE AND DISCONNECTED FROM THE D-VIAL D-LINE TUBE. THE DISCONNECTION OCCURRED AFTER 30 ML HAD BEEN INFUSED TO THE PATIENT. PATIENT ENDED UP RECEIVING 96% OF THE DRAWN DOSE, HOWEVER THE DELIVERY DOME WAS CONTAMINATED AND HAD TO BE PLACED IN DECAYED STORAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22873609 ↗
• MalfunctionAug 22, 2025Leak/Splash; Leak/Splash

  PHYSICIAN WAS USING A TRINAV MICROCATHETER (.021 ID). AFTER INFUSING ABOUT 20CC OF D5W ON THE D LINE AND INFUSING CONTRAST INTERMITTENTLY IN THE B LINE, HE NOTICED FLUID WAS LEAKING FROM THE DVIAL INTO THE DVIAL HOLDER. HE DECIDED TO FINISH THE ADMINISTRATION SINCE IT WAS ALMOST FINISHED AND NOT LEAKING OUTSIDE THE DVIAL HOLDER. AFTER THE PROCEDURE THEY DETECTED NO RADIATION ANYWHERE UNINTENDED AND DISPOSED OF THE RELEVANT MATERIALS INTO A MAYO JAR. INITIAL CALCULATED ADMINISTERED ACTIVITY WAS 72%. THE RSO CAME TO THE HOSPITAL BUT DETERMINED THE ACTUAL PERCENTAGE WAS APPROXIMATELY 82%. HE SAID HE WILL NOT BE FILING A MEDICAL EVENT BUT WAS GOING TO DECIDE WHETHER HE NEEDED TO REPORT THE EVENT TO DHEC. THE MAYO JAR WAS OUT INTO STORAGE SO IT CAN BE DECAYED.

  Patient problems: Insufficient Information

  MAUDE report 22873585 ↗
• MalfunctionAug 22, 2025Decoupling; Decoupling

  THERE WAS SOME ACCUMULATION OF SPHERES IN THE HUB OF THE C-LINE ON THE D-VIAL DURING ADMINISTRATION. THE PHYSICIAN WAS PULSING ON THE D-LINE TO BREAK UP THE LINE OF SPHERES AND THE TUBING OF THE C-LINE ON THE D-VIAL CAME OFF THE HUB. SPHERES WERE SPRAYED ON THE INSIDE OF THE DELIVERY DOME; NO CONTAMINATION WAS DETECTED OUTSIDE OF THE DOME. THE DELIVERY SET AND D-VIAL WERE PREPPED ACCORDING TO THE IFU AND THE ADMINISTRATION WAS PERFORMED ACCORDING TO THE IFU. THERE WAS NO MISADMINISTRATION/UNDER DOSE. TWO DIFFERENT LOT/BATCH NUMBERS WERE PROVIDED AS THIS WAS A SPLIT DOSE.

  Patient problems: Insufficient Information

  MAUDE report 22873550 ↗
• MalfunctionAug 22, 2025Contamination; Contamination

  WHEN INJECTING DF5 BACK INTO THE D-VIAL, A BLACK PARTICULATE FLOATED UP.

  Patient problems: Restless Legs Syndrome

  MAUDE report 22873510 ↗
• MalfunctionAug 22, 2025Contamination; Contamination

  DURING A SIROS DELIVERY THE PHYSICIAN NOTICED A PIECE OF SOMETHING IN THE D VIAL. THE PIECE APPEARED TO BE A GREEN COLOR. THE DELIVERY WAS STOPPED, THE SYSTEM DISCONNECTED AND PUT IN A MAYO JAR. THE PROCEDURE WAS SUCCESSFUL (PATIENT UNAFFECTED) AND WAS STOPPED WITH 85% OF THE PRODUCT DELIVERED. PICTURES WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22873373 ↗
• MalfunctionAug 22, 2025Leak/Splash; Leak/Splash

  AT THE VERY END OF THE PROCEDURE, WHILE FLUSHING THROUGH THE D-LINE A FEW DROPLETS OF D5W WERE NOTICED ESCAPING THROUGH THE SEPTUM OF THE D-VIAL AND ROLLING OVER THE EDGE. NOTHING ESCAPED THE SIROS SYSTEM AND AFTER SURVEYING AND CONDUCTING THE POST PROCEDURE MEASUREMENTS THERE WAS ALMOST NO RESIDUAL AND OVER 100% OF THE WRITTEN DIRECTIVE WAS DELIVERED. WHATEVER MALFUNCTION OCCURRED IT DIDN'T HAPPEN UNTIL WE WERE DONE DELIVERING THE Y90 SPHERES BUT HAD THIS HAPPENED EARLIER IN THE PROCEDURE IT MAY HAVE BEEN A DIFFERENT STORY. I TOOK A SHORT VIDEO OF THE INCIDENT TO BETTER EXPLAIN WHAT HAPPENED AND CAN PROVIDE IT IF NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22873293 ↗