Ivenix, Inc. SET-0014-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 00811505030030), received between Sep 27, 2024 and Sep 22, 2026 — classified as 1 injury, 92 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (26 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Jun 24, 2025Class IIOpen, Classified

   Potential for external cassette leaks

   Z-2233-2025 · Root cause: Process design · Recall details · FDA record ↗

2. May 12, 2025Class IOpen, Classified

   Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.

   Z-1869-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 93 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break; No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856433 ↗
• MalfunctionSep 14, 2026Break

  Blood bag tubing broke when getting spiked to be used by nursing staff. Our health system has had 10 of the events reported across multiple sites. Per our lab manager, this is contributing to wasted blood amidst a blood shortage.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754386 ↗
• MalfunctionSep 10, 2026No Apparent Adverse Event; Priming Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722063 ↗
• MalfunctionSep 9, 2026No Apparent Adverse Event; Incomplete or Inadequate Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695354 ↗
• MalfunctionSep 9, 2026No Apparent Adverse Event; Incomplete or Inadequate Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695351 ↗
• MalfunctionSep 9, 2026No Apparent Adverse Event; Incomplete or Inadequate Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695344 ↗
• MalfunctionAug 13, 2026Leak/Splash; No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50236503 ↗
• MalfunctionAug 11, 2026Break; No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50201421 ↗
• InjuryJul 27, 2026No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available

  The following has been reported:Customer reported: patient that needed blood products, went through 5 blood tubing lines, 6 different pumps because the pumps kept staying the line was not able to be read in the pump. A preliminary review identified the following issue: Set Not Recognized.An active infusion was not stopped. Reporting as a conservative measure. No adverse effects were reported.Additional information is needed to complete the investigation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50013374 ↗
• MalfunctionJun 17, 2026Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: BLOOD TUBING LEAKED AT RIGHT ABOVE THE CASSETTE. DISCARDED NO PATIENT HARM A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET LEAK (EXTERNAL PART) AN ACTIVE INFUSION WAS STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25534500 ↗
• MalfunctionJun 15, 2026Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: 3 DIFFERENT ITEMS OF THE SAME LOT # (FA25C03165) LEAKING BLOOD PRODUCT INTO THE PUMP. AS A RESULT, WE WASTED BLOOD PRODUCT. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET LEAK (EXTERNAL PART). UNKNOWN IF AN ACTIVE INFUSION WAS STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25503712 ↗
• MalfunctionJun 15, 2026Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: 3 DIFFERENT ITEMS OF THE SAME LOT # (FA25C03165) LEAKING BLOOD PRODUCT INTO THE PUMP. AS A RESULT, WE WASTED BLOOD PRODUCT. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET LEAK (EXTERNAL PART). UNKNOWN IF AN ACTIVE INFUSION WAS STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25503709 ↗
• MalfunctionMay 27, 2026Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: ISSUE WITH A BLOOD CASSETTE, IT COMPLETELY STARTED LEAKING THROUGH. NO SAMPLE OR LOT # AVAILABLE. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET LEAK (EXTERNAL PART) UNKNOWN IF AN ACTIVE INFUSION WAS STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25306806 ↗
• MalfunctionMay 20, 2026Obstruction of Flow; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: "RN CALLED CIS TO BEDSIDE FOR ISSUE WITH INFUSING BLOOD. BLOOD SET DESCRIBED TO HAVE BEEN PRIMED APPROPRIATELY VIA BACKPRIME ON THE PUMP. WITNESSED CONTINUOUS UPSTREAM OCCLUSION ALARM. RN ATTEMPTED TO TROUBLESHOOT VIA BACKPRIME WHICH ALSO MAINTAINED CONTINUOUS OCCLUSION. ATTEMPTED TO PRIME BLOOD PRODUCT MANUALLY USING FLOW DIAL (DISCONNECTED FROM PATIENT) AND PRBCS VERY SLOW TO ADVANCE. ATTEMPTED TO INFUSE ON A DIFFERENT PUMP WITH SAME ALARM. CHANGED TO A NEW BLOOD SET AND SUCCESSFULLY PRIMED/INFUSED BLOOD. CONTINUOUS OCCLUSION ALARM. RESOLVED BY CHANGING TO NEW ADMIN SET. DRUG USED: PRBC. PATIENT HARM: NO". AS IT WAS FULL OF A BLOOD PRODUCT IT HAD TO BE DISCARDED. A PRELIMINARY REVIEW OF THE LOGS IDENTIFIED THE FOLLOWING ISSUE: TUBING SET ERROR (CLOGGED ADMIN SET). AN ACTIVE INFUSION WAS NOT STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233827 ↗
• MalfunctionMay 20, 2026Break; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: "RN ATTEMPTED TO SPIKE BLOOD WHEN THE SPIKE OF THE BLOOD TUBING BROKE OFF AT THE BASE OF THE SPIKE. RN STATED THEY DID NOT USE EXCESSIVE FORCE WHEN IT BROKE OFF. NEW TUBING WAS OBTAINED AND USED AS THE SPIKE HAD NOT PIERCED THE BLOOD BAG WHEN IT BROKE. NO INJURY/HARM TO PATIENT OR RN. REPLACED THE TUBING. IT WAS NOT NOTED IF THE BLOOD TUBING WAS SAVED FOR THIS INCIDENT. PATIENT HARM: NO. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET BREAKS (ANY PART) AN ACTIVE INFUSION WAS NOT STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233814 ↗
• MalfunctionMay 18, 2026Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: "PATIENT PUMP WAS ALARMING FOR DOWNSTREAM OCCLUSION WHEN RN WENT TO CLEAR THE PUMP, NOTICED THAT THERE WAS BLOOD LEAKING FROM THE CASSETTE DOWN THE PUMP AND ONTO THE FLOOR. THERE WAS A BLOOD TUBING PRODUCT ISSUE REPORTED AT THE (B)(6) LOCATION. PATIENT HARM: NO". A PRELIMINARY REVIEW OF THE LOGS IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET LEAK (EXTERNAL PART). AN ACTIVE INFUSION WAS STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25204843 ↗
• MalfunctionMay 18, 2026Break; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: "BLOOD TUBING LEAKED WHEN PRIMING AN RBC UNIT. THE TOP OF THE CASSETTE WAS CRACKED AND BLOOD LEAKED OUT. PATIENT HARM: NO. A PRELIMINARY REVIEW OF THE LOGS IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET BREAKS (ANY PART). UNKNOWN IF ISSUE STOPPED AN ACTIVE INFUSION. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25204825 ↗
• MalfunctionMay 15, 2026Failure to Prime; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: "BLOOD WOULD NOT FLOW THROUGH THE CASSETTE, AND THE CASSETTE WOULD NOT BE ACCEPTED BY THE PUMP. NO SAMPLE AVAILABLE. PATIENT HARM: NO. 04/29/2026- CUSTOMER REPORTED: CUSTOMER DOES NOT HAVE ANY OTHER INFORMATION RELATED TO THIS REPORT. THEY HAVE NOT HEARD OF ANY OTHER REPORTS RECENTLY OF MISSING GOLD FOIL, SO WOULD ASSUME THE GOLD FOIL WAS INTACT. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: UNABLE TO PRIME. AN ACTIVE INFUSION WAS STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25189337 ↗
• MalfunctionMay 7, 2026Break; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: CUSTOMER REPORTED: 'JUST HEARD FROM AN ICU NURSE THIS MORNING, THEY HAD AN ICU PATIENT THAT HAD HEPARIN GOING AND THE NURSES WERE IN THE ROOM WHEN AN IV SET "EXPLODED" THEY SAID THE PATIENT HAD AN ANTECUBITAL IV AND HE WAS BENDING HIS ARM AND IT WAS TRYING TO RESTART AND ALL OF A SUDDEN, THE TUBING "EXPLODED", BLOOD BACKED UP THE LINE. THEY DID NOT SAVE THE SET OR THE PACKAGING DUE TO BLOOD IN IT. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET BREAKS (ANY PART). AN ACTIVE INFUSION WAS STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112700 ↗
• MalfunctionMay 4, 2026Obstruction of Flow; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: "PUMP ALARM STATING "OCCLUSION" WHEN TRYING TO BACK PRIME. ONCE NEW TUBING SET WAS OBTAINED AND USED ON THE SAME PUMP THERE WERE NO ISSUES. WHAT DRUG WAS USED FOR THE INFUSION? NORMAL SALINE PRIMING. REMOVED ALL TUBING AND STARTED OVER AGAIN. PATIENT HARM: NO. 04/15/2026: NURSE REPORTED: THE NURSES MADE A FEW ATTEMPTS TO RESOLVE BUT NO MATTER WHAT HAPPENED IT SAID "OCCLUSION" AND THEN DID NOT ALLOW THEM TO BACK PRIME SO THAT WE COULD SPIKE THE BLOOD, THEY THEN SEARCHED FOR ANOTHER KIT. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: TUBING SET ERROR (CLOGGED ADMIN SET). AN ACTIVE INFUSION WAS NOT STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072931 ↗
• MalfunctionMay 1, 2026Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: "PER NURSING REPORT, UPON PRIMING THE TUBING WITH SALINE- IT WAS NOTED THAT SALINE WAS LEAKING FROM THE SECONDARY PORT CONNECTION ON THE CASSETTE. THE TUBING DID NOT CONTAIN BLOOD PRODUCTS, BUT THE DRIP CHAMBER HAS SOME MINIMAL BLOOD NOTED SO WAS PLACED INTO A BIOHAZARD BAG. NEW TUBING WAS OBTAINED FOR THE BLOOD TRANSFUSION. PATIENT HARM: NO. A PRELIMINARY REVIEW OF THE LOGS IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET LEAK (EXTERNAL PART). AN ACTIVE INFUSION WAS NOT STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25057787 ↗
• MalfunctionApr 29, 2026Manufacturing, Packaging or Shipping Problem; No Apparent Adverse Event

  DURING THE EXECUTION OF LEAK PREVENTION TEST ON (B)(6) 2025, DURING A FRESENIUS KABI V&V PLAN, A SAMPLE FROM ONE OF THE CONDITIONING GROUP SET-0014 EXPERIENCED A LEAK ON THE PRIMARY PORT DUE TO TUBING BOND SEPARATION. MICROSCOPIC EVIDENCE INDICATES INSUFFICIENT SOLVENT APPLICATION AND/OR INCOMPLETE TUBE INSERTION DURING ASSEMBLY RESULTING IN A LEAK. THE DEFECT WAS DETERMINED TO BE MOST LIKELY CAUSED DUE TO THE MANUFACTURING PROCESS AND NOT RELATED TO THE DESIGN CHANGE UNDER TEST. THIS WAS IDENTIFIED ON (B)(6) 2026. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25037641 ↗
• MalfunctionApr 15, 2026No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available

  THE FOLLOWING HAS BEEN REPORTED: BIOMED REPORTED: 'BLOOD TUBING SET THAT THE PUMP WOULD NOT RECOGNIZE THE CASSETTE. BIOMED TRIED TWO DIFFERENT PUMPS, AND STILL WOULD NOT RECOGNIZE. SPIKED A NEW SET AND IT WORKED. A PRELIMINARY REVIEW OF THE LOGS IDENTIFIED THE FOLLOWING ISSUE: SET NOT RECOGNIZED. AN ACTIVE INFUSION WAS NOT STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24886244 ↗
• MalfunctionApr 14, 2026Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: CUSTOMER REPORTED: "IT STATES THAT THE BLOOD TUBING IS LEAKING FROM THE SECONDARY SITE. LOT NUMBER FA25A21013. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET LEAK (EXTERNAL PART) UNKNOWN IF AN ACTIVE INFUSION WAS STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873162 ↗
• MalfunctionApr 10, 2026Obstruction of Flow; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: CUSTOMER REPORTED: "NURSE KEPT RECEIVING UPSTREAM OCCLUSION ALARM WHEN BACKPRIMING, DESPITE CLAMP BEING OPEN, RED CAP REMOVED. NO BLOOD BAG HOOKED UP INITIALLY - JUST TRYING TO BACKPRIME LINE. THEY FUMBLED WITH IT' FOR ~20 MIN INCLUDING ATTACHING THE BLOOD BAG TO ALSO TRY TO BACKPRIME WITH NO SUCCESS. ONCE THEY TRIED A NEW BLOOD ADMIN SET, IT WORKED FINE. TUBING NOT SAVED DUE TO BLOOD BEING IN THE LINE. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: UNRESOLVED OCCLUSION ALARMS AN ACTIVE INFUSION WAS NOT STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845136 ↗