Amplatzer™ 9-SB-024Recalls & reported problems
St. Jude Medical, Inc. · Sizing Balloon II · Class 2
All models of Amplatzer (37)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00811806011523), received between Mar 19, 2024 and Sep 6, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Insert” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Insert2
- Material Deformation2
- Difficult to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 6, 2024Difficult to Insert; Difficult to Advance; Material Deformation; Difficult to Insert; Difficult to Advance; Material Deformation
IT WAS REPORTED THAT A 24MM AMPLATZER SIZING BALLOON II WAS SELECTED FOR A PROCEDURE ON (B)(6) 2024 TO MEASURE THE VESSEL. DURING THE PROCEDURE AFTER REMOVING THE SHEATH THE SIZING BALLOON WAS CAUGHT UNDER THE PATIENT'S SKIN AND COULD NOT BE INSERTED INTO THE BLOOD VESSEL. THE TIP OF DEVICE APPEARED TO BE FLARED. THE DEVICE WAS REPLACED WITH A NEW 34MM AMPLATZER SIZING BALLOON II. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20161908 ↗MalfunctionMar 19, 2024Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation
IT WAS REPORTED THAT ON (B)(6) 2024, A 24MM AMPLATZER SIZING BALLOON II WAS CHOSEN TO SIZE THE SEPTAL DEFECT PRIOR TO A PATENT FORAMEN OVALE (PFO) CLOSURE. THE PHYSICIAN NOTED THAT PART OF THE BALLOON WAS "FOLDED" INSTEAD OF BEING IN A FLAT STATE, WHICH WAS MAKING THE INSERTION MORE DIFFICULT IN THE PATIENT. INFLATING AND DEFLATING WAS NOT CHANGING OR UNFOLDING THE BALLOON. THE SIZING BALLOON WAS ABLE TO BE USED AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18937382 ↗
Other Catheter, intravascular occluding, temporary devices
- Pruitt F3 Carotid Shunt 2012-10Lemaitre Vascular, Inc. · Catheter, Intravascular Occluding, Temporary1 death158 reports
- GORE Molding Occlusion Balloon Catheter MOB37W. L. Gore & Associates, Inc. · Catheter, Intravascular Occluding, Temporary6 deaths152 reports
- Bridge Occlusion Balloon 590-001Spectranetics Corporation · Catheter, Intravascular Occluding, Temporary4 deaths57 reports
- Pruitt F3 Carotid Shunt e2012-10Lemaitre Vascular, Inc. · Catheter, Intravascular Occluding, Temporary53 reports
- Pruitt F3 Carotid Shunt 2013-10Lemaitre Vascular, Inc. · Catheter, Intravascular Occluding, Temporary46 reports
- Equalizer™ M001171100Boston Scientific Corporation · Catheter, intravascular occluding, temporary18 reports
- Pruitt F3 Carotid Shunt e2013-10Lemaitre Vascular, Inc. · Catheter, Intravascular Occluding, Temporary17 reports
- TRANSFORM M003SSC07070Stryker Corporation · Catheter, intravascular occluding, temporary17 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page