AmplatzerRecalls & reported problems across all models
St. Jude Medical, Inc. · 37 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Amplatzer model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1,028
- Deaths reported
- 14
- Injuries reported
- 398
- Recalls
- 1
We found 37 models of Amplatzer by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 1,028 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2018 and Sep 29, 2026 — classified as 14 deaths, 398 injuries, 616 malfunctions.
The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (405 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Amplatzer recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 12, 2023Open, Classified
There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used.
Z-2110-2023 · Root cause: Device Design · Recall details · FDA record ↗
Most reported Amplatzer problems
Device problems
- Difficult to Fold, Unfold or Collapse405
- Material Deformation256
- Migration or Expulsion of Device109
- Adverse Event Without Identified Device or Use Problem92
- Off-Label Use61
- Patient Device Interaction Problem34
- Improper or Incorrect Procedure or Method29
- Air/Gas in Device23
Patient problems
- No Clinical Signs, Symptoms or Conditions602
- No Known Impact Or Consequence To Patient123
- No Consequences Or Impact To Patient88
- Pericardial Effusion26
- Atrial Fibrillation17
- Non specific EKG/ECG Changes16
- Air Embolism15
- Arrhythmia15
Amplatzer models
37 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Amplatzer™ 9-ASD-MF-025Transcatheter septal occluder1 death183 reports
- Amplatzer™ PFO OccluderTranscatheter septal occluder1 death153 reports
- Amplatzer™ 9-ASD-MF-030Transcatheter septal occluder149 reports
- Amplatzer™ ASDS-14F-075Catheter, percutaneous1 recall1 death35 reports
- Amplatzer™ 9-PDA-005OCCLUDER, PATENT DUCTUS, ARTERIOSUS79 reports
- Amplatzer™ PFO OccluderTranscatheter septal occluder1 death62 reports
- Amplatzer™ 9-PDA-004OCCLUDER, PATENT DUCTUS, ARTERIOSUS45 reports
- Amplatzer™ 9-ASD-MF-035Transcatheter septal occluder1 death31 reports
- Amplatzer™ 9-PDA-006OCCLUDER, PATENT DUCTUS, ARTERIOSUS26 reports
- Amplatzer™ 9-PDA-003OCCLUDER, PATENT DUCTUS, ARTERIOSUS1 death24 reports
- Amplatzer™ 9-PDA2-06-06OCCLUDER, PATENT DUCTUS, ARTERIOSUS18 reports
- Amplatzer™ PFO OccluderTranscatheter septal occluder18 reports
- Amplatzer™ 9-PDA-007OCCLUDER, PATENT DUCTUS, ARTERIOSUS15 reports
- Amplatzer™ 9-GW-002WIRE, GUIDE, CATHETER2 deaths14 reports
- Amplatzer™ 9-VSD-MUSC-016Transcatheter septal occluder2 deaths14 reports
- Amplatzer™ 9-PDA2-06-04OCCLUDER, PATENT DUCTUS, ARTERIOSUS13 reports
- Amplatzer™ 9-PDA2-04-06OCCLUDER, PATENT DUCTUS, ARTERIOSUS12 reports
- Amplatzer™ 9-PDA2-05-06OCCLUDER, PATENT DUCTUS, ARTERIOSUS12 reports
- Amplatzer™ 9-AVP2-022Device, Vascular, for Promoting Embolization1 death11 reports
- Amplatzer™ 9-VSD-MUSC-012Transcatheter septal occluder11 reports
- Amplatzer™ 9-VSD-MUSC-008Transcatheter septal occluder1 death10 reports
- Amplatzer™ 9-VSD-MUSC-010Transcatheter septal occluder10 reports
- Amplatzer™ 9-VSD-MUSC-014Transcatheter septal occluder1 death10 reports
- Amplatzer™ 9-VSD-MUSC-018Transcatheter septal occluder10 reports
- Amplatzer™ 9-AVP2-018Device, Vascular, for Promoting Embolization8 reports
- Amplatzer™ 9-PDA2-03-06OCCLUDER, PATENT DUCTUS, ARTERIOSUS7 reports
- Amplatzer™ 9-PDA2-05-04OCCLUDER, PATENT DUCTUS, ARTERIOSUS7 reports
- Amplatzer™ 9-VSD-MUSC-006Transcatheter septal occluder1 death7 reports
- Amplatzer™ 9-ASD-MF-018Transcatheter septal occluder6 reports
- Amplatzer™ 9-PDA2-03-04OCCLUDER, PATENT DUCTUS, ARTERIOSUS5 reports
- Amplatzer™ 9-PDA2-04-04OCCLUDER, PATENT DUCTUS, ARTERIOSUS5 reports
- Amplatzer™ 9-SB-018Catheter, intravascular occluding, temporary5 reports
- Amplatzer™ 9-AVP2-003Device, Vascular, for Promoting Embolization3 reports
- Amplatzer™ 9-AVP2-020Device, Vascular, for Promoting Embolization3 reports
- Amplatzer™ 9-SB-034Catheter, intravascular occluding, temporary3 reports
- Amplatzer™ 9-SB-024Catheter, intravascular occluding, temporary2 reports
- Amplatzer™ 9-VSD-MUSC-004Transcatheter septal occluder2 reports
Recent Amplatzer adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Difficult to Fold, Unfold or Collapse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941143 ↗MalfunctionSep 29, 2026Difficult to Fold, Unfold or Collapse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941058 ↗MalfunctionSep 28, 2026Difficult to Fold, Unfold or Collapse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926391 ↗MalfunctionSep 25, 2026Difficult to Fold, Unfold or Collapse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903203 ↗MalfunctionSep 25, 2026Difficult to Fold, Unfold or Collapse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50901470 ↗MalfunctionSep 23, 2026Difficult to Fold, Unfold or Collapse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862998 ↗MalfunctionSep 17, 2026Difficult to Fold, Unfold or Collapse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809479 ↗InjuryAug 28, 2026Insufficient Device Problem Information
It was reported that on an unknown date, a 30mm Amplatzer Cribriform Occluder was chosen for implant. Subsequently, the patient reported experiencing low blood oxygen levels, bubbles in the bloodstream, blood in the urine, blue urine, and loss of consciousness.
Patient problems: Air Embolism; Hypoxia; Syncope/Fainting
MAUDE report 50505828 ↗InjuryAug 14, 2026Migration or Expulsion of Device
It was reported that on (b)(6) 2026, a 25mm Amplatzer Cribriform Occluder was chosen for implant. The defect characteristics were reported as a tunnel measuring 12 mm, an aortic rim >5 mm, and aneurysm excursion of approximately 1 mm. Device sizing was determined using transesophageal echocardiography (TEE), and TEE was also used as the imaging modality during the procedure. During post-procedure follow-up on (b)(6) 2026, the implanted device was found to be malpositioned. The migration/malposition was identified at follow-up by transthoracic echocardiogram. No clinical signs or symptoms were reported during or after the event. As a result, percutaneous withdrawal of the device was performed successfully. The patient remained hemodynamically stable throughout the procedure. There was no clinically significant delay in procedure and no adverse patient effects reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50261321 ↗MalfunctionAug 13, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50240553 ↗MalfunctionAug 11, 2026Difficult to Fold, Unfold or Collapse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50209066 ↗MalfunctionJul 17, 2026Difficult to Fold, Unfold or Collapse
IT WAS REPORTED THAT ON (b)(6) 2026, A 16MM AMPLATZER MUSCULAR VSD OCCLUDER WAS CHOSEN FOR IMPLANT USING A NON-ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE DEVICE DID NOT TAKE DESIRED SHAPE RESULTING IN COBRA SHAPE AND IT WAS RETRIEVED BACK. THE PROCEDURE WAS ABORTED. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO ANGULATION OR KINK NOTED IN THE DELIVERY SYSTEM. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25861064 ↗InjuryJul 14, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT (B)(6) 2026, AN UNKNOWN SIZE AMPLATZER MUSCULAR VSD OCCLUDER WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2026, THE OCCLUDER WAS SUCCESSFULLY EXPLANTED.
Patient problems: Hemolysis; Insufficient Information
MAUDE report 25817813 ↗MalfunctionJul 13, 2026Difficult to Fold, Unfold or Collapse
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25808027 ↗MalfunctionJul 1, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2026, A 25MM AMPLATZER CRIBRIFORM WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM. DURING THE PROCEDURE, THE DEVICE WAS INTRODUCED AND ADVANCED FOR PLACEMENT, AND AFTER DEPLOYMENT, AN INCREASE IN THE PATIENT¿S LEFT ATRIAL (LA) PRESSURE WAS OBSERVED, WHICH WAS SUSTAINED. THE PATIENT DID NOT DEVELOP ANY CLINICAL SYMPTOMS, AND NO CLINICAL DIAGNOSIS WAS MADE IN RELATION TO THE PRESSURE INCREASE. THE DEVICE WAS NOT COMPLETELY RELEASED AND WAS REMOVED PRIOR TO RELEASE FROM THE DELIVERY CABLE. THEREFORE, THE PHYSICIAN CHOSE TO STOP THE PROCEDURE FOR SAFETY REASONS, AND NO OTHER DEVICE WAS ATTEMPTED. NO INTERVENTION OR TREATMENT WAS REQUIRED. THE INCREASE IN LA PRESSURE WAS DESCRIBED AS A CLINICALLY RECOGNIZED PHENOMENON THAT MAY OCCUR AFTER DEVICE PLACEMENT DUE TO OCCLUSION OF THE SHUNT, WHICH CAN INCREASE LOAD ON THE LEFT ATRIUM AND RIGHT HEART, AND CANNOT BE DETERMINED IN ADVANCE. NO ALLEGATIONS WERE MADE AGAINST ANY ABBOTT DEVICE, AND THE EVENT WAS NOT ATTRIBUTED TO DEVICE PERFORMANCE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; High Blood Pressure/ Hypertension
MAUDE report 25679611 ↗
Other St. Jude Medical, Inc. products
- Tendril15 models · 49,498 reports
- Octrode10 models · 36,740 reports
- Proclaim12 models · 35,038 reports · 17 recalls
- Durata28 models · 19,805 reports
- Assurity MRI2 models · 17,838 reports · 1 recall
- Gallant8 models · 12,885 reports · 5 recalls
- Quartet10 models · 11,001 reports
- MitraClip19 models · 9,056 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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