Transpac™ 460990471Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840619069087), received between Sep 8, 2023 and Aug 27, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K052828); 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2025Crack; Crack

  EVENT OCCURRED REGARDING A MONITORING KIT W/ SAFESET¿ II, 03 ML FLUSH DEVICE & MARVELOUS VALVE WHERE IT WAS STATED IN THE REPORT "THAT A-LINE TUBING BROKE OFF IN TUBING.". THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22903740 ↗
• MalfunctionAug 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A MEDWATCH WAS RECEIVED REGARDING A MONITORING KIT W/SAFESET¿ II, 03 ML FLUSH DEVICE & MARVELOUS VALVE THAT EXPERIENCED LEAKAGE DURING USE. IT WAS REPORTED THAT "PATIENT HAD R [RIGHT] ULNAR A-LINE [ARTERIAL LINE]. TUBING NOT DUE UNTIL TOMORROW NIGHT. GRABBING BLOOD TO SEND DOWN A LACTIC ACID. BLOOD DRAWN. AS PUSHING THROUGH "WASTED" BLOOD THROUGH SAFESET, BALLOON IN SYRINGE POPS. BLOOD LEAKS QUICKLY OUT OF SYRINGE FROM A-LINE. LINE CLAMPED. TUBING CHANGED." ADDITIONAL EVENT INFORMATION OBTAINED FROM UFMW: THIS IS NOT A LABORATORY DEVICE OR LABORATORY TEST. THE LOCATION WHERE EVENT OCCURRED WAS IN HOSPITAL¿S CRITICAL CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22812661 ↗
• MalfunctionNov 27, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  THE COMPLAINT/EVENT INVOLVED A MONITORING KIT W/SAFESET¿ II, 03 ML FLUSH DEVICE AND MARVELOUS VALVE. THE REPORT STATES THAT THE ARTERIAL LINE SYRINGE DID NOT CLIP INTO PLACE. IT APPEARED THAT THE WHITE DISC ABOVE THE SYRINGE IS LOOSE PREVENTING THE CLIPS TO SECURE INTO REST OF DEVICE. THERE WAS NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20800700 ↗
• MalfunctionNov 23, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED WITH REGARDS TO MONITORING KIT W/SAFESET II¿, 03 ML FLUSH DEVICE & MARVELOUS VALVE THAT EXPERIENCED LEAKAGE. THE REPORTER STATED THAT " A-LINE TUBING FAULTY, BLOOD SPEWING FROM SMALL HOLE ON SIDE PORT OF STOP-COCK. A-LINE REMOVED FROM PATIENT AND SEQUESTERED. THE EVENT DATE WAS ON 22-OCT-2024. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT. THE AMOUNT OF BLOOD LOSS WAS UNKNOWN. THEN THE CUSTOMER WAS ASKED ABOUT THE STATUS OF THE PRODUCT AT THE TIME OF EVENT SHE ANSWERED "WHEN CONNECTED TO TUBING, WITH BLOOD COMING OUT".

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20767006 ↗
• MalfunctionOct 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION REGARDING THIS COMPLAINT WAS RECEIVED AS FOLLOWS: A MEDSUN MEDWATCH UF/IMPORTER REPORT # (B)(4) WAS RECEIVED ON 27-NOV-2024 THAT STATED "ICU MEDICAL DEVICE A-LINE PRESSURE TUBING SET LEAKED WHEN RN PUT CONNECTED THE SET TO IVF IN A PRESSURE BAG. RN SET UP PRESSURE TUBING AND CONNECTED TO PATIENT AND NOTED THAT BLOOD WAS BACKFLOWING INTO THE SET. SHE THEN REALIZED THERE WAS A LEAK IN THE SYSTEM. SHE DISCONNECTED THE SET AND REPLACED IT WITH ANOTHER PRESSURE TUBING SET WHICH WORKED WITHOUT ISSUE. THE LEAK OCCURRED AT THE FLUSH CHAMBER JUST ABOVE WHERE FLUID WOULD ENTER THE CHAMBER." THIS ISSUE WAS ORIGINALLY REPORTED BY (B)(6), A NURSE OF (B)(6) HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20359675 ↗
• MalfunctionSep 8, 2023Reflux within Device; Separation Failure; Reflux within Device; Separation Failure

  A MEDSUN MANDATORY MEDWATCH REPORT (UF/IMPORTER REPORT# (B)(4) ) WAS RECEIVED ON 13-OCT-2023 WHICH STATED: RN NOTED THAT A-LINE PRESSURE TUBING HAD BECOME DISCONNECTED AT A SITE NOT INTENDED TO BE ABLE TO COME APART. AT 3-WAY SITE CLOSEST TO TRANSDUCER, PORT DIRECTED TOWARD A-LINE INSERTION SITE, THE PRESSURE TUBING HAD BECOME DISCONNECTED. THIS DISCONNECTION OCCURRED BELOW THE LUER LOCK, AT A PART THAT IS NOT INTENDED TO COME APART (NO WAY TO REATTACH/TIGHTEN CONNECTION POINT). NEW A-LINE TUBING EXCHANGED TO PATIENT AND FAULTY TUBING SEQUESTERED FOR PICK UP BY SUPPLY CHAIN. ADDITIONAL EVENT INFORMATION OBTAINED FROM UFMW: THE REPORT WAS COMPLETED BY ANNA CERILLI OF YALE-NEW HAVEN HOSPITAL. THE SUSPECTED MEDICAL DEVICE WAS A MONITORING KIT W/SAFESET¿ II, 03 ML FLUSH DEVICE & MARVELOUS VALVE WITH LIST NUMBER 460990471, LOT NUMBER 13618618, AND WITH COMMON DEVICE NAME TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR. THE DEVICE IS AVAILABLE FOR EVALUATION. MOREOVER, THE CONTACT PERSON FOR THIS FACILITY IS ANNA CERILLI. THE LOCATION WHERE EVENT OCCURRED WAS AT CRITICAL CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17715295 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052828. One submission often covers many models, so check the product and lot details in each record.

• Z-1071-2019 · Nov 27, 2018 · Terminated
  ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Squeeze Flush, Macrodrip (Pole Mount), REF: 42640-06