OccluderRecalls & reported problems across all models

We found 4 models of Occluder by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 35 adverse event reports in the FDA's MAUDE database, received between Jun 5, 2017 and Aug 29, 2025 — classified as 3 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (19 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. 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

Most reported Occluder problems

Occluder models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Occluder M0062201090

  CATHETER, URETERAL, GASTRO-UROLOGY
  23 reports
• Occluder M0062201070

  CATHETER, URETERAL, GASTRO-UROLOGY
  6 reports
• Occluder M0062201100

  CATHETER, URETERAL, GASTRO-UROLOGY
  5 reports
• Occluder M0062201080

  CATHETER, URETERAL, GASTRO-UROLOGY
  1 report

Recent Occluder adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2025Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT AN OCCLUDER BALLOON CATHETER WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE. DURING THE PROCEDURE, THE BALLOON WAS INFLATED, AND THEY NOTICED IMMEDIATELY THAT THERE WAS A LEAKAGE FROM THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED THAT THE BALLOON WAS WITH A SMALL HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22925742 ↗
• MalfunctionJul 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN OCCLUDER BALLOON CATHETER DEVICES WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON; HOWEVER, THE CONTRAST WAS VISIBLY LEAKING OUT ON FLUOROSCOPY. REPORTEDLY, THE OCCLUSION BALLOON DID HAVE A SLIT IN IT WHICH CAUSED CONTRAST TO LEAK OUT AND THE BALLOON COULD NOT INFLATE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. THIS REPORT PERTAINS TO THE FIRST OF TWO OCCLUDER BALLOON CATHETER DEVICES USED IN THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22401506 ↗
• MalfunctionJul 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN OCCLUDER BALLOON CATHETER DEVICES WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON; HOWEVER, THE CONTRAST WAS VISIBLY LEAKING OUT ON FLUOROSCOPY. REPORTEDLY, THE OCCLUSION BALLOON DID HAVE A SLIT IN IT WHICH CAUSED CONTRAST TO LEAK OUT AND THE BALLOON COULD NOT INFLATE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. THIS REPORT PERTAINS TO THE SECOND OF TWO OCCLUDER BALLOON CATHETER DEVICES USED IN THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22401503 ↗
• MalfunctionNov 2, 2023Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER BALLOON CATHETER WAS USED IN THE URETER DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE OCCLUDER BALLOON WAS INSERTED IN THE KIDNEY; HOWEVER, WHEN THEY WENT TO INFLATE THE BALLOON, THERE WAS NO EFFECT. THEY TRIED TO INFLATE AGAIN BUT STILL THE BALLOON DID NOT INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUDER BALLOON CATHETER. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF BALLOON WAS RUPTURED. PLEASE SEE DEVICE ANALYSIS RESULTS FOR FULL INVESTIGATION DETAILS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18060565 ↗
• MalfunctionOct 18, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A OCCLUDER BALLOON CATHETER WAS USED DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS NOTICED THAT THE INFLATED BALLOON WAS NOT VISIBLE UNDER A FLUOROSCOPY AND SUSPECTED TO HAVE BEEN BURST. HOWEVER, ONCE THEY PROCEED WITH THE PROCEDURE, THEY CHECK THE BALLOON'S CONDITION, AND IT TURNED OUT TO HAVE A HOLE ON IT CAUSING IT TO LEAK HENCE IT GOT DEFLATED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 24, 2023: IT WAS REPORTED THAT A OCCLUDER BALLOON CATHETER WAS USED IN THE KIDNEY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17957024 ↗
• MalfunctionOct 3, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUSION BALLOON CA DEVICE WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THEY PLACED A GUIDEWIRE THROUGH A CYSTOSCOPE AND PLACE THE CATHETER OVER THE WIRE INTO KIDNEY. AFTER PLACEMENT THE Y REMOVED THE GUIDEWIRE AND CUFFED THE BALLOON; HOWEVER, THE BALLOON BURST WITHOUT ANY INTERFERENCE OF THE OTHER ITEMS. IT WAS REPORTED THAT THEY REMOVED THE CATHETER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUSION BALLOON CA DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17865358 ↗
• MalfunctionSep 18, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER BALLOON CATHETER WAS USED DURING A TRANSJUGULAR LIVER BIOPSY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS NOTICED THAT THE OCCLUDER BALLOON HAD A FLY INSIDE THE PACKAGING. IT WAS REPORTED THAT THE BOX AND THE STERILE PACKAGING WERE BOTH SEALED WITH NO SIGN OF DAMAGE OR TAMPERING. IT WAS DEEMED CONTAMINATED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUDER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17765868 ↗
• MalfunctionAug 7, 2023Material Puncture/Hole; Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO OCCLUDER BALLOON CATHETERS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO OCCLUDER BALLOON CATHETERS WERE TO BE USED IN THE URETER AND KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, BOTH BALLOONS WERE LEAKING AND THERE WAS A POSSIBLE TEAR OR HOLE IN THE BALLOON WHEN TESTED PRIOR TO INSERTION. THE PROCEDURE WAS COMPLETED WITHOUT USING AN OCCLUSION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17469381 ↗
• MalfunctionAug 7, 2023Material Puncture/Hole; Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO OCCLUDER BALLOON CATHETERS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO OCCLUDER BALLOON CATHETERS WERE TO BE USED IN THE URETER AND KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, BOTH BALLOONS WERE LEAKING AND THERE WAS A POSSIBLE TEAR OR HOLE IN THE BALLOON WHEN TESTED PRIOR TO INSERTION. THE PROCEDURE WAS COMPLETED WITHOUT USING AN OCCLUSION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17469169 ↗
• MalfunctionOct 21, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER BALLOON CATHETER WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE DEVICE WAS INSERTED IN THE URETER AND THE PHYSICIAN FILLED IN THE BALLOON; HOWEVER, THE BALLOON BURST WHEN INFLATED TO 11 ATM. IT WAS REPORTED THAT THE DEVICE WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITHOUT USING AN OCCLUDER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT OUTCOME OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15649519 ↗
• MalfunctionOct 20, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER BALLOON CATHETER WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE BALLOON WAS ABLE TO BE INFLATED WHEN IT WAS PLACED IN THE PELVIC URETERIC JUNCTION; HOWEVER, THE BALLOON LOOKED DEFLATED AFTER A WHILE, AND DOES NOT LOOK INFLATED UNDER THE X-RAY VIEW. THE DEVICE WAS THEN REMOVED FROM THE PATIENT, AND IT WAS CONFIRMED THAT THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUDER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15638088 ↗
• MalfunctionJan 20, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER BALLOON CATHETER DEVICE WAS USED BELOW THE PELVIC URETERIC JUNCTION (PUJ) DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE POSITION OF THE PATIENT WAS CHANGED FROM SUPINE TO PRONE, THE BALLOON WAS CONFIRMED TO BE INFLATED UNDER X-RAY; HOWEVER, IT WAS NOTICED THAT THE CONTRAST WAS LEAKING FROM THE BALLOON A MOMENT AFTER. THE DEVICE WAS THEN REMOVED FROM THE PATIENT AND IT WAS FOUND THAT THE BALLOON BURST. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13306565 ↗
• MalfunctionOct 21, 2021Burst Container or Vessel; Deflation Problem; Inflation Problem; Burst Container or Vessel; Deflation Problem; Inflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER BALLOON CATHETER WAS USED DURING A KIDNEY STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON HAVE DEFLATION PROBLEMS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUDER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12672029 ↗
• MalfunctionOct 21, 2021Burst Container or Vessel; Deflation Problem; Inflation Problem; Burst Container or Vessel; Deflation Problem; Inflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER BALLOON CATHETER WAS USED DURING A KIDNEY STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON HAVE DEFLATION PROBLEMS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUDER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12672007 ↗
• MalfunctionSep 13, 2021Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUSION BALLOON CATHETER WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON WAS INFLATED SUCCESSFULLY; HOWEVER, AFTER REACHING THE REQUIRED POSITION, IT WAS NOTICED THAT THE BALLOON WAS DAMAGED. A PHOTO SENT BY THE CUSTOMER CANNOT CONFIRM ON WHAT THE DAMAGE WAS NOTED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUSION BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12459175 ↗

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