Occluder M0062201070Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729191988), received between Jan 8, 2019 and Aug 29, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, 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 ↗
• 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 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 ↗
• MalfunctionAug 22, 2019Burst Container or Vessel; Burst Container or Vessel

  BOSTON SCIENTIFIC CORPORATION RECEIVED AN UNAUTHORIZED RETURN OF AN OCCLUDER BALLOON CATHETER THAT WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PNL) PROCEDURE PERFORMED ON (B)(6) 2019. IT WAS FOUND THAT THE BALLOON RUPTURED DURING THE PROCEDURE. REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUDER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8920199 ↗
• InjuryJan 8, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER BALLOON CATHETER WAS USED DURING A URETEROSCOPIC STONE RETRIEVAL PROCEDURE PERFORMED ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT UNDERWENT A URETEROSCOPIC STONE RETRIEVAL PROCEDURE AND THE OCCLUDER TUBE WAS LEFT INSIDE THE PATIENT WHEN SHE WAS DISCHARGED ON (B)(6) 2018 DUE TO URETERIC OBSTRUCTION. WHILST RECOVERING AT HOME, IT WAS NOTICED THAT THE TUBE WAS DRAINING LESS. BY (B)(6) 2016 THE DEVICE HAD COMPLETELY STOPPED DRAINING. THE PATIENT ATTENDED A&E ON (B)(6) 2016 WITH PAIN AND A FEVER. THE PATIENT WAS THEN ADMITTED TO THE HOSPITAL AND A NEPHROSTOGRAM WAS PERFORMED ON (B)(6) 2016. THIS SHOWED THAT THE DEVICE HAD FRACTURED. THE TUBE REMAINED IN THE KIDNEY BUT WAS NOT CONNECTED TO THE DRAINAGE BAG. THE TUBE WAS REMOVED VIA LAPAROSCOPY THE SAME DAY. IT WAS REPLACED WITH A NEW TUBE THAT DRAINED WELL. THE PATIENT WAS DISCHARGED HOME AND A GOOD RECOVERY WAS MADE, WITH THE TUBE BEING REMOVED ON (B)(6) 2016. THE PATIENT CURRENT CONDITION AND PROGNOSIS IS UNDER INVESTIGATION. THE PATIENT CONTINUES TO SUFFER WITH BACK PAIN AND HAS SIGNIFICANT SCARRING FROM THE NEED FOR A FURTHER OPERATION.

  Patient problems: Fever; Pain

  MAUDE report 8226072 ↗
• MalfunctionJan 8, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER BALLOON CATHETER WAS USED ALONG WITH A GEMINI RETRIEVAL BASKET IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUDER BALLOON CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8225993 ↗