Amplatzer™ 9-ASD-038Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05415067019370), received between Feb 17, 2019 and Aug 12, 2022 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (2 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 38MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED TO BE IMPLANTED USING A 14FR NON-ABBOTT DELIVERY SHEATH. IT WAS NOTED THAT DURING PROCEDURE THE AMPLATZER SEPTAL OCCLUDER EXHIBITED A DEFORMATION UPON DEPLOYMENT. THE DECISION WAS MADE TO ABORT THE IMPLANT PROCEDURE. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15218317 ↗
• InjuryAug 1, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A 38MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR AN IMPLANT ON (B)(6) 2022. THE DEVICE WAS SIZED USING A 34MM SIZING BALLOON AND AN ASSESSMENT VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). DURING THE PROCEDURE THE PHYSICIAN HELD THE DEVICE FOR 5 MINS PRIOR TO RELEASING IT. ONCE RELEASED, IT WAS NOTED DURING AN ANGIOGRAM THAT THE DEVICE HAD EMBOLIZED. THE PATIENT WAS SENT FOR SURGERY TO EXPLANT THE DEVICE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE SURGICAL INTERVENTION WAS CONSIDERED AN EMERGENCY PROCEDURE TO PREVENT PERMANENT IMPAIRMENT. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15141423 ↗
• MalfunctionJun 14, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 38MM AMPLATZER SEPTAL OCCLUDER SELECTED FOR AN IMPLANT ON (B)(6)2022. DURING DEPLOYMENT , THE PHYSICIAN NOTICED THAT THE DEVICE WAS NOT TAKING PROPER SHAPE. DEVICE WAS REMOVED FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. A NEW 36MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED AND IMPLANTED. PATIENT STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14689676 ↗
• MalfunctionJul 14, 2020Migration; Migration

  A 38MM ASO EMBOLIZED A FEW HOURS AFTER SUCCESSFUL DEPLOYMENT. THE PATIENT WENT TO SURGERY WHERE THEY RETRIEVED THE DEVICE SUCCESSFULLY AND SURGICALLY REPAIRED THE ASD. THE PATIENT IS DOING WELL.

  Patient problems: Embolism

  MAUDE report 10270222 ↗
• InjuryFeb 17, 2019Unintended Movement; Unintended Movement

  ON (B)(6) 2018, A 38MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED. ON (B)(6) 2019, ABBOTT WAS MADE AWARE FROM PATIENT DEVICE TRACKING THAT THE DEVICE WAS REMOVED ON AN UNKNOWN DATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8346495 ↗