MEDRAD® Avanta Fluid Management Injection System (REF AVA 500 TABL, AVA 500 PEDL)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00616258008578), received between Oct 9, 2018 and Nov 18, 2025 — classified as 1 death, 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

6 other recalls cover devices cleared under the same FDA submission (K050456); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• DeathNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO BAYER. A PATIENT WAS UNDERGOING A CORONARY ANGIOGRAM WHILE CONNECTED TO A MEDRAD® AVANTA FLUID MANAGEMENT SYSTEM (SERIAL NUMBER (B)(6). DURING THE FIRST INJECTION OF CONTRAST, AIR WAS VISUALIZED ON THE DISPLAYED IMAGES AFTER WHICH NON-SPECIFIED EMERGENCY TREATMENT WAS IMMEDIATELY INITIATED, AND CARDIOPULMONARY RESUSCITATION (CPR) / ADVANCED CARDIOVASCULAR LIFE SUPPORT (ACLS) WAS PERFORMED BY THE MEDICAL TEAM. DESPITE THESE EFFORTS, THE PATIENT COULD NOT BE RESUSCITATED AND CEASED TO BREATHE.

  Patient problems: Air Embolism

  MAUDE report 23582317 ↗
• InjuryJan 23, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  BAYER MEDICAL CARE INC. WAS INFORMED THAT A 60-YEAR-OLD MALE EXPERIENCED AN ALLEGED AIR INJECTION DURING A HEART CATHETERIZATION PROCEDURE WHILE CONNECTED TO A MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM (SN (B)(6)). THE CUSTOMER REPORTED THAT AN UNDISCLOSED AMOUNT OF AIR WAS VISUALIZED AFTER A CONTRAST INJECTION IN THE LEFT CORONARY SYSTEM. FOLLOWING THE EVENT, THE PATIENT WENT INTO CARDIAC ARREST, WAS IMMEDIATELY RESUSCITATED AND WAS SUCCESSFULLY STABILIZED. THE PATIENT IS REPORTED AS DOING WELL.

  Patient problems: Air Embolism; Cardiac Arrest

  MAUDE report 21218217 ↗
• InjuryFeb 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TO A BAYER REPRESENTATIVE THAT AN ALLEGED AIR INJECTION OCCURRED ON A (B)(6) MALE PATIENT WHILE UTILIZING THE AVANTA FLUID MANAGEMENT SYSTEM ((B)(4)) TO PERFORM A CORONARY ANGIOGRAPHY PROCEDURE. DURING THE FIRST INJECTION, WITH THE CATHETER LOCATED IN THE LEFT CORONARY ARTERY, 5 ML OF AIR WAS OBSERVED ON THE FLUOROSCOPIC IMAGES. THE PATIENT SUFFERED A TRANSIENT CARDIAC ARREST BUT WAS REPORTED TO LATER RECOVER.

  Patient problems: Air Embolism

  MAUDE report 13536776 ↗
• InjurySep 11, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON (B)(6) 2019, THE CUSTOMER REPORTED THAT A PATIENT SUFFERED A CARDIAC ARREST AFTER AN UNDISCLOSED AMOUNT OF AIR WAS ALLEGEDLY INJECTED WHILE CONNECTED TO AN AVANTA FLUID MANAGEMENT SYSTEM. POST RESUSCITATION, A BALLOON PUMP WAS INSERTED AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) IN STABLE CONDITION FOR FURTHER EVALUATION AND CARE.

  Patient problems: Air Embolism; Cardiac Arrest

  MAUDE report 8989333 ↗
• InjuryOct 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BAYER REPRESENTATIVE REPORTED THE FOLLOWING: A (B)(6), MALE PATIENT WITH AN ADMITTING DIAGNOSIS OF CORONARY ARTERY DISEASE WAS CONNECTED TO THE AVANTA FLUID MANAGEMENT SYSTEM WHILE UNDERGOING A CARDIAC CATHETERIZATION PROCEDURE WITH PCI (PERCUTANEOUS CORONARY INTERVENTION). AN ALLEGED AIR INJECTION OCCURRED DURING THE FINAL IMAGE POST PCI WITHIN THE RIGHT CORONARY ARTERY (RCA) FOLLOWED BY A DISSECTION AT THE BIFURCATION OF THE RCA AND ANOMALOUS CIRCUMFLEX. A BAYER CLINICAL SUPPORT SPECIALIST WAS PRESENT FOR THE CASE AND PROVIDED THAT THE OPINION OF THE PHYSICIAN PERFORMING THE CASE WAS THE AIR WAS INTRODUCED VIA A SIDE ARM ADAPTOR THAT WAS ATTACHED BETWEEN THE SPAT AND THE PATIENT CATHETER. ADDITIONALLY, THE PHYSICIAN PROVIDED THAT THE MOST PROBABLE CAUSE OF THE DISSECTION WAS MOST LIKELY THE PATIENT CATHETER AND NOT THE INJECTOR; HE SURMISED AN AIR BUBBLE MAY CONTRIBUTE TO THE SIZE OF THE DISSECTION, BUT IS UNLIKELY THE CAUSE. THE PATIENT EXPERIENCED CHEST PAIN AND REQUIRED MEDICAL MANAGEMENT ALONG WITH ADMISSION TO THE STEP DOWN CARDIAC CARE UNIT. THE PATIENT WAS REPORTED TO RECOVER AND HAS BEEN DISCHARGED FROM THE HOSPITAL AT THIS TIME.

  Patient problems: Air Embolism

  MAUDE report 7947729 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050456. One submission often covers many models, so check the product and lot details in each record.

• Z-2296-2026 · Apr 24, 2026 · Open, Classified
  Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad Avanta Injection System; Catalog number: AVA 500 MPAT (Part 2 of 2); Affected materi
• Z-0870-2013 · Nov 5, 2012 · Terminated
  MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiogr
• Z-2866-2011 · Jun 2, 2011 · Terminated
  MEDRAD Avanta Fluid Management Injection System, Catalog numbers: AVA 500 TABL, AVA 500 PEDL Product Usage: Administration of intravascular radio-opaque contrast media and commo
• Z-1199-2010 · Jan 6, 2010 · Terminated
  Avanta Fluid Management Injection System, Avanta Multi-Patient Disposable Set (MPAT) High Pressure Check Valve, Catalog number AVA 500 MPAT, Material number 3018231.
• Z-0082-06 · Sep 20, 2005 · Terminated
  Medrad Avanta Single Patient Disposable Sets. Catalog number AVA 500 SPAT
• Z-0083-06 · Sep 20, 2005 · Terminated
  Medrad Avanta Multi-patient Disposable Sets. Catalog number AVA 500 MPAT