Amplatzer™ 9-ASD-016Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05415067019240), received between Mar 8, 2022 and Mar 31, 2023 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (13 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 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16653313 ↗
• MalfunctionMar 24, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 16MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT WITH A 8F NON-ABBOTT DELIVERY SHEATH. DURING DEPLOYMENT, THE DEVICE HAD A COBRA DEFORMATION. A DECISION WAS MADE TO RECAPTURE THE DEVICE AND ABORT THE PROCEDURE WITH NO REPLACEMENT DEVICE. THE DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO REPORT OF ANY INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK NOTICED IN THE DELIVERY CABLE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO REPORT OF ANY ADVERSE PATIENT CONSEQUENCES AND THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16613050 ↗
• InjuryMar 23, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2022 A 16MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2023, AT 6 MONTHS FOLLOW-UP, IT WAS NOTED THAT THE DEVICE HAD EMBOLIZED IN THE PULMONARY ARTIES. THE IMPLANTER BELIEVE THE CAUSE OF EMBOLIZATION WAS FLOPPY SEPTUM. RETRIEVAL WAS NOT POSSIBLE, THE PHYSICIANS DECIDED TO LEAVE THE DEVICE IN PLACED. PATIENT STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16598681 ↗
• MalfunctionNov 28, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A 16MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED. THE DEVICE WAS SIZED BASED ON LABEL SIZING INSTRUCTIONS. THE DEVICE WAS PLACED WITH GOOD RESULT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER 24 HOURS OF MONITORING. WHEN REVIEWING TRANSTHORACIC ECHOCARDIOGRAM IMAGES TAKEN 24 HOURS POST PROCEDURE, THE PHYSICIAN NOTED DEVICE HAD EMBOLIZED TO THE PATIENT'S ABDOMINAL AORTA. THE PATIENT WAS CALLED AT HOME TO RETURN FOR A NON-EMERGENT DEVICE REMOVAL PROCEDURE. THE PATIENT WAS EXPERIENCING NO SYMPTOMS OR COMPLICATIONS OF EMBOLIZED DEVICE. ON (B)(6) 2022, THE DEVICE WAS RETRIEVED AND REMOVED VIA TRANSCATHETER SNARE IN A CATHETERIZATION LAB PROCEDURE. A REPLACEMENT 37MM NON-ABBOTT DEVICE WAS IMPLANTED WITH GOOD RESULT. THERE WERE NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15873739 ↗
• MalfunctionNov 10, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 16MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANTATION USING A 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING THE PROCEDURE, DURING DEPLOYMENT, THE DEVICE DEFORMED AND TWISTED. THE DEVICE WAS NOT RELEASED INSIDE PATIENT ANATOMY, THERE WAS NO ANGULATION OR KINK NOTED IN THE DELIVERY SYSTEM, AND THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THE DEVICE WAS REMOVED AND REPLACED WITH AN 18MM AMPLATZER SEPTAL OCCLUDER TO RESOLVE THE EVENT. THE PATIENT IS REPORTED TO BE DISCHARGED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15774131 ↗
• MalfunctionOct 18, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 16MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 7F AMPLATZER TORQVUE DELIVERY SYSTEM. THERE WAS NO ANGULATION OR KINKS NOTED IN THE DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE RELEASING THE DEVICE FROM THE DELIVERY SYSTEM, IT WAS NOTED THAT THE DEVICE DEPLOYED IN A COBRA DEFORMATION. THE DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. A REPLACEMENT 16MM AMPLATZER SEPTAL OCCLUDER (8197889) WAS IMPLANTED WITHOUT COMPLICATIONS. THE PATIENT REMAINED HEMODYNAMICALLY STABLE DURING THE PROCEDURE. THE PATIENT WAS REPORTED AS STABLE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY AND NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15621022 ↗
• MalfunctionSep 28, 2022Difficult to Fold, Unfold or Collapse; Patient-Device Incompatibility; Difficult to Fold, Unfold or Collapse; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, A 16MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE WAS NOT ABLE TO DEPLOY WELL AND WAS NOT FULLY RELEASED FROM THE DELIVERY SYSTEM. IT WAS DECIDED THAT THE PRODUCT WOULD BE REPLACED USING A 18MM NON-ABBOTT OCCLUDER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15497261 ↗
• MalfunctionSep 22, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 16MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS SELECTED FOR IMPLANT USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING THE PROCEDURE, THE ASO WAS OPENED IN THE LEFT ATRIUM BUT DID NOT TAKE THE APPROPRIATE SHAPE. THE DEVICE WAS RECAPTURED INSIDE THE DELIVERY SYSTEM AND REDEPLOYED, BUT THE SAME RESULT WAS OBSERVED. THE DEVICE WAS REMOVED FROM THE PATIENT AND EXCHANGED FOR A NEW 16MM ASO, WHICH WAS SUCCESSFULLY IMPLANTED. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THE PATIENT STATUS WAS REPORTED AS STABLE. NO PATIENT CONSEQUENCES WERE REPORTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15465425 ↗
• MalfunctionSep 14, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, AN 18MM AMPLATZER SEPTAL OCCLUDE WAS CHOSEN FOR AN IMPLANT USING A 12F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING THE PROCEDURE THE LEFT DISC DEFORMED INTO A COBRA SHAPE. ATTEMPTS WERE MADE TO CORRECT THE ISSUE BUT WAS UNSUCCESSFUL. 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 THE DEVICE WAS EXCHANGED FOR A NEW 16MM AMPLATZER SEPTAL OCCLUDER THAT WAS IMPLANTED SUCCESSFULLY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15420531 ↗
• MalfunctionSep 14, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6)2022 ] A 16MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT. DURING IMPLANTATION, THE DEVICE WAS DEPLOYED AND WAS TAKING A COBRA FORMATION. THE DEVICE WAS THEN RECAPTURED AND REMOVED FROM THE PATIENT. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15420253 ↗
• MalfunctionJul 19, 2022Difficult to Fold, Unfold or Collapse; Improper or Incorrect Procedure or Method; Difficult to Fold, Unfold or Collapse; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A AMPLATZER SEPTAL OCCLUDER 16MM WAS SELECTED FOR AN IMPLANT ON (B)(6) 2022. DURING THE PROCEDURE THE DEVICE DEFORMED IN COBRA AT 2-3 ATTEMPTS AND WAS REMOVED FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE. THERE WAS NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM AND NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. DEVICE WAS EXCHANGE TO A NEW AMPLATZER SEPTAL OCCLUDER 16MM AND WAS IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15059597 ↗
• MalfunctionJul 19, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 16MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANTATION USING AN ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, THE LEFT ATRIAL DISK COULD NOT BE DEPLOYED INTO THE CORRECT SHAPE. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT, AND THERE WAS NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THE DEVICE WAS REMOVED AND REPLACED. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15055762 ↗
• MalfunctionJun 22, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2022, A 16MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT. DURING THE PROCEDURE THE DEVICE PRESENTED WITH A COBRA SHAPE DEFORMATION WHILE TRYING TO DEPLOY IN THE PATIENTS LEFT ATRIUM. THERE WAS NO KINKS OR ANGULATION NOTICED WITH THE DELIVERY SYSTEM. THERE WAS NO DIFFICULTIES POSITIONING THE DEVICE FOR PLACEMENT AND NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THE DEVICE WAS REMOVED BY THE DELIVERY CABLE AND REPLACED WITH A 20MM AMPLATZER SEPTAL OCCLUDER. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14766100 ↗
• InjuryMay 13, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED ON (B)(6) 2022 THE PATIENT UNDERWENT IMPLANT OF A 16MM AMPLATZER SEPTAL OCCLUDER (ASO). THE PATIENT'S DEFECT HAD BEEN MEASURED USING A SIZING BALLOON AND INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE DEFECT MEASURED FOR A 14MM HOWEVER A 16MM ASO WAS CHOSEN. POST OP IMAGING CONFIRMED THE DEVICE WAS STABLE. THE FOLLOWING DAY, PRIOR TO DISCHARGE A ROUTINE ECHOCARDIOGRAM WAS PERFORMED AND THE DEVICE HAD BEEN REPORTED TO HAVE EMBOLIZED INTO THE AORTA. THAT SAME DAY, THE PATIENT WAS BROUGHT TO THE CATH LAB FOR DEVICE RETRIEVAL. THE DEVICE WAS REMOVED USING A 12F CATHETER AND SNARE. A 24MM ASO WAS CHOSEN FOR THE REPLACEMENT DEVICE HOWEVER, THE DEVICE WAS TOO SMALL. STILL CONNECTED TO THE CABLE, THE DEVICE WAS REMOVED FROM THE PATIENT AND EXCHANGED WITH A NEW 24MM ASO DEVICE, WHICH WAS SUCCESSFULLY IMPLANTED. THE PATIENT DID NO EXPERIENCE ANY SYMPTOMS. THE PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14392715 ↗
• MalfunctionMar 22, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 16MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR PROCEDURE ON (B)(6) 2022. DURING PROCEDURE, THE DEVICE WAS ADVANCED THROUGH THE SHEATH. THE DEVICE WAS RE-SHEATHED TWICE IN ATTEMPT TO ACHIEVE AN OPTIMAL POSITION. AFTER THE SECOND ATTEMPT, THE DEVICE EMERGED PRESENTING IN A COBRA SHAPE DEFORMATION. THE DEVICE WAS NOT RELEASED FROM THE DELIVERY CABLE. THE DEVICE WAS REMOVED AND EXCHANGED WITH A 17MM AMPLATZER SEPTAL OCCLUDER. THE DEVICE WAS PLACED SUCCESSFULLY AND IS WORKING AS INTENDED, CONFIRMED BY IMAGING. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13853959 ↗
• MalfunctionMar 8, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2022, A 16MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT FOR AN ATRIAL SEPTAL DEFECT (ASD) CLOSURE. UPON DEPLOYMENT A COBRA HEAD DEFORMATION WAS REPORTED ON THE LEFT ATRIAL DISC. THE PHYSICIAN RE-SHEATHED AND RETRIEVED THE DEVICE. THE CAUSE OF THE DEFORMATION IS UNKNOWN. A NEW 16MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED. THERE WAS NO IMPACT ON THE PATIENT OR CLINICALLY SIGNIFICANT DELAY REPORTED AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13696515 ↗