MEDRAD® Avanta Single Patient Disposable Set – Transducer Compatible AVA 500 SPAT LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00616258021485), received between Jun 30, 2022 and Jun 30, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Air/Gas in Device” (1 report).

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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2022Air/Gas in Device

  AIR BUBBLES SEEN IN TUBING DURING CARDIAC CATH PROCEDURE. PATIENT BECAME SYMPTOMATIC, DIAPHORETIC, HYPOTENSIVE, ST ELEVATION NOTED WITHOUT PULSES PEA (PULSELESS ELECTRICAL ACTIVITY). CPR INITIATED, CODE BLUE ACTIVATED. ROSC (RETURN OF SPONTANEOUS CIRCULATION) ACHIEVED AFTER 2 ROUNDS OF CPR. PATIENT TO ICU AWAKE, ALERT, AND STABLE CONDITION. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Air Embolism; Diaphoresis; Diminished Pulse Pressure; Low Blood Pressure/ Hypotension

  MAUDE report 14885374 ↗

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