AVANTI 504616ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10705032010283), received between Aug 13, 2019 and May 4, 2026 — classified as 1 injury, 40 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (29 reports).

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 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Packaging Problem

  AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25075818 ↗
• MalfunctionMay 4, 2026Packaging Problem

  AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25075814 ↗
• MalfunctionMay 4, 2026Packaging Problem

  AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25075762 ↗
• MalfunctionMay 4, 2026Packaging Problem

  AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25075747 ↗
• MalfunctionMay 4, 2026Packaging Problem

  AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25075739 ↗
• MalfunctionMay 4, 2026Packaging Problem

  AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25075719 ↗
• MalfunctionMay 4, 2026Packaging Problem

  AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25075713 ↗
• MalfunctionMay 4, 2026Packaging Problem

  AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25075707 ↗
• MalfunctionMay 4, 2026Packaging Problem

  AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25075702 ↗
• MalfunctionMay 4, 2026Packaging Problem

  AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25075695 ↗
• MalfunctionMay 4, 2026Packaging Problem

  AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25075689 ↗
• MalfunctionMay 4, 2026Packaging Problem

  AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25074351 ↗
• MalfunctionMay 4, 2026Packaging Problem

  AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25074147 ↗
• MalfunctionMay 4, 2026Packaging Problem

  AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25074130 ↗
• MalfunctionMay 4, 2026Packaging Problem

  AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25074120 ↗
• MalfunctionMay 4, 2026Packaging Problem

  AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25074041 ↗
• MalfunctionMay 4, 2026Packaging Problem

  AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073963 ↗
• MalfunctionMay 4, 2026Packaging Problem

  AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073906 ↗
• MalfunctionMay 4, 2026Packaging Problem

  AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073810 ↗
• MalfunctionMay 4, 2026Packaging Problem

  AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073768 ↗
• MalfunctionMay 4, 2026Packaging Problem

  AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073750 ↗
• MalfunctionMay 4, 2026Packaging Problem

  AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073743 ↗
• MalfunctionMay 4, 2026Packaging Problem

  AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073730 ↗
• MalfunctionMay 4, 2026Packaging Problem

  AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073720 ↗
• MalfunctionMay 4, 2026Packaging Problem

  AS REPORTED, THE PUNCTURE NEEDLE OF A 5F AVANTI PLUS INTRODUCER SHEATH WAS FOUND LOOSE AND DETACHED INSIDE THE PACKAGE. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL. THE DEVICE AND 134 STERILE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073712 ↗