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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00616258021447), received between Nov 16, 2023 and Apr 16, 2024 — classified as 1 death, 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathApr 16, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON APRIL 10, 2024, BAYER MEDICAL CARE INC. WAS NOTIFIED OF A PATIENT DEATH THAT OCCURRED IN (B)(6) OF 2024 WHILE THE PATIENT WAS CONNECTED TO A MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM (SN (B)(6)) DURING A RIGHT-HEART CATHETERIZATION TO DETERMINE SUITABILITY FOR A TRICUSPID VALVE REPLACEMENT. AT AN UNSPECIFIED POINT DURING THE STUDY, THE PATIENT SUDDENLY BECAME UNSTABLE DUE TO UNKNOWN CLINICAL FACTORS. THE DETAILS OF ANY MEDICAL INTERVENTION UNDERTAKEN LEADING UP TO THE PATIENT'S DEATH ARE UNKNOWN, DESPITE MULTIPLE ATTEMPTS TO GAIN THIS INFORMATION. BAYER MEDICAL CARE INC. HAS NOT RECEIVED AN AUTOPSY REPORT AND/OR CAUSE OF DEATH STATEMENT. ALTHOUGH UNRELATED TO THE PATIENT EVENT ABOVE, THE HOSPITAL STAFF FURTHER COMMUNICATED THAT DURING THE PROCEDURE, THE HEMODYNAMIC WAVEFORM, AS MEASURED BY A THIRD PARTY'S PRESSURE TRANSDUCER CONNECTED TO THE MEDRAD® SINGLE PATIENT DISPOSABLE SET (SPAT) HAD DAMPENED.

  Patient problems: Hemodynamic instability; Insufficient Information

  MAUDE report 19118267 ↗
• InjuryFeb 7, 2024Adverse 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 NOTIFIED OF AN ALLEGED AIR INJECTION THAT OCCURRED WHILE A PATIENT WAS CONNECTED TO A MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM (SERIAL NUMBER (B)(6) ). IT WAS REPORTED THAT, DURING THE FIRST INJECTION OF CONTRAST INTO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY, A DROP IN BLOOD PRESSURE OCCURRED. AFTER ADMINISTRATION OF ATROPINE AND APPROXIMATELY FIVE MINUTES OF BASIC LIFE SUPPORT (BLS), THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS REPORTED TO HAVE RECOVERED AND IS DOING WELL.

  Patient problems: Insufficient Information; Low Blood Pressure/ Hypotension

  MAUDE report 18657731 ↗
• InjuryNov 16, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON NOVEMBER 9, 2023 BAYER SERVICE RECEIVED INFORMATION THAT A PATIENT SUFFERED AN INTRAPROCEDURAL INFARCTION DUE TO AN ALLEGED AIR EMBOLISM WHILE CONNECTED TO A MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM, SERIAL NUMBER (B)(6). THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information; Non specific EKG/ECG Changes

  MAUDE report 18148625 ↗

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-0083-06 · Sep 20, 2005 · Terminated
  Medrad Avanta Multi-patient Disposable Sets. Catalog number AVA 500 MPAT
• Z-0082-06 · Sep 20, 2005 · Terminated
  Medrad Avanta Single Patient Disposable Sets. Catalog number AVA 500 SPAT