Amplatzer™ 9-SB-034Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00811806011530), received between Dec 4, 2019 and Nov 21, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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. 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.

• MalfunctionNov 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2025, A 34MM AMPLATZER SIZING BALLOON II WAS CHOSEN FOR AN ATRIAL SEPTAL DEFECT (ASD) CLOSURE PROCEDURE. DURING PROCEDURE, THE SIZING BALLOON WAS EXPLODED. A NEW 34MM AMPLATZER SIZING BALLOON II WAS CHOSEN AND COMPLETED THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617823 ↗
• MalfunctionAug 21, 2024Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024, A 34MM AMPLATZER SIZING BALLOON WAS CHOSEN TO MEASURE AN ATRIAL SEPTAL DEFECT (ASD). THE BALLOON COULD NOT BE INSERTED INTO THE VESSEL AS IT WOULD CATCH ON SKIN AT THE ACCESS SITE. ACCESS SITE WAS EXPANDED USING FORCEPS, AND IT STILL DID NOT INSERT. THE TIP OF THE SIZING BALLOON WAS OBSERVED TO BE FLARED AND BENT UP. A REPLACEMENT 34MM AMPLATZER SIZING BALLOON (LOT: 9156076) WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO REPORTED PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20015387 ↗
• InjuryDec 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, A 34 MM AMPLATZER SIZING BALLOON II WAS SELECTED FOR USE. DURING THE PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED. AT THE END OF THE PROCEDURE, A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS TRANSFERRED TO SURGERY WHERE NO LEAK WAS FOUND. THE PATIENT WAS STABLE BEFORE, DURING, AND AFTER THE ISSUE. THE CAUSE OF THE PERICARDIAL EFFUSION IS NOT CLEAR. THE PATIENT IS STABLE POST-OPERATIVELY.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 9410256 ↗