AVANTI 504615ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705032010276), received between Jun 15, 2023 and Mar 9, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 16, 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.

• MalfunctionMar 9, 2026Device Contamination with Chemical or Other Material

  AS REPORTED, A FOREIGN OBJECT WAS FOUND INSIDE A 5F 11CM AVANTI+ SHEATH INTRODUCER .021" TRANSRADIAL KIT PRIOR TO SURGERY. A NEW CATHETER SHEATH WAS USED. THERE WAS NO REPORTABLE PATIENT INJURY. THE FOREIGN OBJECT INVOLVED WAS FREELY MOVEABLE. THE PACKAGING WAS NOTED TO CONTAIN FOREIGN MATERIAL INSIDE. THE PRODUCT WAS STORED IN THE LABORATORY AS REQUIRED, AND THE ACTUAL PRODUCT ITSELF WAS NOT DAMAGED. THE HOSPITAL REPORTED THIS CASE AS AN ADVERSE EVENT TO THE CHINA NMPA. THE DEVICE WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24547682 ↗
• MalfunctionMay 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 5F 11CM AVANTI PLUS TRANS-RADIAL CATHETER SHEATH INTRODUCER (CSI) COULD NOT PASS DURING USE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: THE DEVICE WAS RETURNED WITH THE VESSEL DILATOR SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043525 ↗
• InjuryDec 26, 2023Fracture; Fracture

  MULTIPLE ATTEMPTS TO OBTAIN SUPPLEMENTAL INFORMATION WERE MADE INCLUDING THE RETURN OF THE DEVICE; HOWEVER, ADDITIONAL EVENT DETAILS AND PRODUCT RETURN INFORMATION WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18393641 ↗
• InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, IT WAS DIFFICULT TO INTRODUCE A 5F 11CM AVANTI PLUS CATHETER SHEATH INTRODUCER (CSI) INTO THE ARTERY DUE TO THE CSI HAVING A ¿FRAGILE TIP AND A ROUGH BODY¿. THERE WERE REPORTS OF VASOSPASM, RADIAL ARTERY DISSECTION, AND LOSS OF RADIAL PULSE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: Obstruction/Occlusion; Vascular Dissection

  MAUDE report 17292236 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, IT WAS DIFFICULT TO INTRODUCE A 5F 11CM AVANTI PLUS CATHETER SHEATH INTRODUCER (CSI) INTO THE ARTERY DUE TO THE CSI HAVING A ¿FRAGILE TIP AND A ROUGH BODY¿. THERE WERE REPORTS OF VASOSPASM, RADIAL ARTERY DISSECTION, AND LOSS OF RADIAL PULSE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: Obstruction/Occlusion; Vascular Dissection

  MAUDE report 17134358 ↗