SIROS Delivery Set SIR-10300Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00850014612023), received between Aug 22, 2025 and Aug 18, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Failure to Deliver

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50303640 ↗
• MalfunctionNov 4, 2025Complete Blockage; Failure to Deliver; Complete Blockage; Failure to Deliver

  THE IR EXPERIENCED UNUSUAL RESISTANCE WHEN ATTEMPTING TO DELIVERY THE FIRST ALIQUOT OF THE DOSE. THE DOSE STOPPED AT THE MIDDLE OF THE C-LINE AND WOULD NOT GO ANY FURTHER. AN ATTEMPT TO "UNCLOG" THE DELIVERY SET WAS ATTEMPTED BUT WAS UNSUCCESSFUL. THE DECISION WAS MADE TO ABORT AND RESCHEDULE AS A SECOND DOSE COULD NOT BE DRAWN. IT WAS STATED THAT THE PATIENT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23468698 ↗
• MalfunctionAug 22, 2025Air/Gas in Device; Air/Gas in Device

  THERE WAS A SIGNIFICANT COLUMN OF AIR THAT CAME OUT OF THE D VIAL DURING THE FIRST ALIQUOT OF THE ADMINISTRATION, SPECIFICALLY FROM THE C-LINE CONNECTIONS. THE LINES WERE FLUSHED WITH APPROX. 40 CCS OF D5W PRIOR TO ADMINISTRATION. PHYSICIAN WOULD LIKE TO KNOW WHERE THE AIR IS COMING FROM, INSIDE THE D-VIAL OR IS THERE AN ISSUE WITH THE DELIVERY SETS. IS IT POSSIBLE TO LOOK AT FLUSHING THE D-LINE AND C-LINE INDEPENDENTLY? I SUSPECT THAT THE AIR HAS SOMETHING TO DO WITH THE RED CONNECTOR PIECE, I HAVE NOTICED THAT IT IS LOOSE AND NOT SECURE DURING THE PRIMING PROCESS AND THE LINES BECOME DISCONNECTED.

  Patient problems: Insufficient Information

  MAUDE report 22878233 ↗
• MalfunctionAug 22, 2025Decoupling; Decoupling

  DOCTOR HAD ALREADY DELIVERED 20 ML OF D5W THROUGH THE D-LINE TO THE PATIENT. THE DOCTOR ATTACHED ANOTHER FULL 20 ML SYRINGE OF D5W TO THE D-LINE (TO FULLY DELIVER MICROSPHERES) AND WITH HIS FIRST ALIQUOT THE D-LINE SYRINGE CONNECTOR BROKE OFF (WITH THE SYRINGE STILL ATTACHED) FROM THE MAIN D-LINE. NUCLEAR MEDICINE WAS THEN BROUGHT INTO SURVEY POTENTIAL CONTAMINATION. IT WAS CONFIRMED WITH THERE BEING NO RADIOACTIVITY ON THE "CONTAMINATED" TOWELS (AND FURTHER CONFIRMED ON IMMEDIATE CLEANUP POST-DELIVERY SURVEYS AND POST MEASUREMENT READINGS). AFTER CONFIRMING SAFETY OF THE ENVIRONMENT, THE DOCTOR SIMPLY RE-ATTACHED THE D-LINE SYRINGE CONNECTOR (WITH SYRINGE STILL ATTACHED) TO THE D-LINE TUBING AND CAREFULLY DELIVERED ANOTHER 20 ML OF D5W WITH NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22873536 ↗
• MalfunctionAug 22, 2025Break; Break

  LUER-LOCK CONNECTION ON D LINE CRACKED AND BROKE OFF. AS THE DOCTOR WAS FINISHING ADMINISTRATION OF SIR-SPHERES, THE OUTER PORTION OF THE LUER-LOCK OF THE D LINE CONNECTION GOING INTO THE D-VIAL, CRACKED AND A PIECE FLEW ACROSS THE INSIDE OF THE SIROS BOX. AT THIS POINT, 30 ML OF D5 HAD ALREADY BEEN ADMINISTERED THROUGH THE D LINE, AND 30 ML OF 50/50 THROUGH THE B LINE. THE DOCTOR WAS STILL ABLE TO ADMINISTER AN ADDITIONAL 10-15 ML OF 50/50 THROUGH THE B LINE AND CONTRAST FLOWED THROUGH THE PROGREAT MICROCATHETER WITHOUT A PROBLEM. VISUAL INSPECTION OF D/C LINE WAS DONE AND NO CLUMPING OF PARTICLES WERE SEEN. THE DOCTOR DID NOT FEEL IT WAS SAFE TO CONTINUE ADMINISTRATION THROUGH THE D LINE WITH FEAR OF BUILDING UP ADDITIONAL PRESSURE WITHIN THE SYSTEM. THE CASE WAS COMPLETED AT THIS TIME. PRELIMINARY SURVEY SHOWED LESS THAN 5% RESIDUAL LEFT OF THE DOSE AND NO DETECTION OF RADIATION LEAKAGE WITHIN THE SIROS DOME. THOUGHTS ARE EITHER A DEFECTIVE/THIN PLASTIC ON THE LUER-LOCK AREA OR WHEN THE D LINE CONNECTIONS WERE ATTACHED, THAT THIS WAS POSSIBLY DONE TOO TIGHT. SYSTEM WAS LABELED TO SAVE FOR RETURN TO SIRTEX IF THEY WOULD LIKE TO ASSESS THE SYSTEM.

  Patient problems: Insufficient Information

  MAUDE report 22873518 ↗
• InjuryAug 22, 2025Improper Flow or Infusion; Improper Flow or Infusion

  3 DOSE SPLIT - 3 GBQ (10.8MCI-.4 GBQ, 13.5 MCI-.5 GBQ AND 24.3MCI-.9 GBQ) DRAW WAS DONE BY JUBILANT RADIOPHARMACY ON (B)(6) 2024. FIRST DOSE ADMINISTERED BY THE PHYSICIANS (ACTUALLY PUSHED ON THE D LINE) GOT ABOUT 1ML IN AND THEN MOVED TO B LINE TO FOLLOW WITH STRAIGHT CONTRAST RUN (SHE KNOWS WE RECOMMEND 50/50, WE DISCUSSED). PHYSICIAN WENT BACK TO THE D LINE AND TRIED TO PUSH FELT RESISTANCE AND SIR-SPHERES STARTED TO COME OUT OF THE D-VIAL. WE STOPPED IMMEDIATELY AND ASSESSED THE SITUATION. WE MADE SURE ALL LINES WERE TIGHT/HOOKED UP PROPERLY (AS THEY WERE WENT STEP BY STEP IN THE BEGINNING), DISCUSSED A POSSIBLE KINKED CATHETER OR SHEATH THAT COULD KINK CATHETER, BUT PHYSICIAN DID NOT FEEL THAT WAS THE CASE. WE WERE IN DISTAL VESSELS AND AT THE TIME WE WERE TREATING SEGMENT 5 WITH THIS 10.8MCI DOSE. PHYSICIAN THEN BAGGED UP EVERYTHING (SIROS, DELIVERY TUBING, D-VIAL AND CATHETER) AND SENT TO NUCLEAR MEDICINE TO MEASURE. READING WAS HIGH, BUT WAS NOT A DIRECT COMPARISON IN THE BEGINNING NO NALGENE BOTTLE/ACRYLIC BOTTLES USED JUST THE DOSE SITTING SEATED IN SIROS UNIT AND TUBING WRAPPED UP. PHYSICIAN WANTED TO PULL ANOTHER DOSE, BASED ON WHAT WAS DELIVERED, BUT WAS UNABLE TO GET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22873375 ↗
• MalfunctionAug 22, 2025Leak/Splash; Leak/Splash

  THE DELIVERY SET WAS FLUSHED ACCORDING TO IFU PRIOR TO STARTING THE ADMINISTRATION. AFTER THE 2ND ALIQUOT, THE DELIVERY SET STARTED LEAKING WHERE THE A LINE COMES OUT OF THE "Y" INTERSECTION. A POOLING OF LIQUID THE SIZE OF A QUARTER WAS OBSERVED. WE STOPPED THE ADMINISTRATION AND HAD TO RE-DRAW THE DOSE.

  Patient problems: Insufficient Information

  MAUDE report 22873226 ↗
• MalfunctionAug 22, 2025Leak/Splash; Leak/Splash

  A SMALL POOL OF ACTIVITY WAS IDENTIFIED ON "THE" BASE OF THE DELIVERY DOME (UNDER THE LID ON THE CLEAR ACRYLIC) AT THE END OF TREATMENT. THE POOL OF LIQUID WAS LOCATED UNDER THE C LINE CONNECTION. NO DRIPS COMING FROM THE CONNECTION WERE OBSERVED DURING DELIVERY. IR DID NOT HAVE ANY ISSUES WITH CONNECTION. C LINE WAS NOT DISCONNECTED AFTER TREATMENT. GLOVES WERE NOT HOT. THE SPILL WAS CLEANED AND CONTAINED. THE SIROS DOME WAS SENT TO DECAY. D VIAL AND DELIVERY SET WERE MARKED TO BE INSPECTED AFTER DECAY. 96% OF DOSE DELIVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22873186 ↗
• MalfunctionAug 22, 2025Leak/Splash; Leak/Splash

  FOLLOWING THE COMPLETION OF THE ADMINISTRATION, A SMALL PUDDLE OF LIQUID UNDERNEATH THE "Y" CONNECTION ON THE DELIVERY SET WAS IDENTIFIED. ONCE THE MICROCATHETER, D-VIAL, AND DELIVERY SET WERE REMOVED, THE LID TO THE SIROS DOME WAS PLACED ON TOP OF THE BASE. THE SIROS DELIVERY DOME WAS THEN SURVEYED AND RESULTS CAME BACK HOT. THE SIROS DELIVERY DOME WAS THEN PLACED INTO AN APPROPRIATE DECAY LOCATION.

  Patient problems: Insufficient Information

  MAUDE report 22873071 ↗