Sniper SBC0629-STR-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00853359008032), received between May 19, 2020 and Nov 1, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 1, 2023

  PATIENT UNDERGOING YTTRIUM-90 RADIOEMBOLIZATION OF LIVER METASTASIS FROM RECTAL CANCER. BALLOON OCCLUSION CATHETER DEPLOYED IN RIGHT HEPATIC ARTERY OSTENSIBLY TO DIRECT RADIOACTIVE SPHERES TO THE TARGET AREA WHILE PREVENTING NONTARGET EMBOLIZATION TO BOWEL AND THE REMAINDER OF THE LIVER NOT CONTAINING TUMOR. TWO CONSECUTIVE SNIPER BALLOON MICROCATHETERS FAILED, THE FIRST BEFORE ANY RADIOACTIVE BEADS HAD BEEN ADMINISTERED THROUGH IT AND THE SECOND DURING ADMINISTRATION OF AN ALIQUOT OF RADIOACTIVE BEADS. REMOVING THE SECOND MICROCATHETER EXPOSED THE PATIENT TO THE POSSIBILITY OF REFLUX OF THE PARTICLES INTO THE GASTRODUODENAL ARTERY AND NONTARGET EMBOLIZATION TO THE BOWEL AND REMAINDER OF THE LIVER. ULTIMATELY, A THIRD BALLOON OCCLUSION MICROCATHETER BY DIFFERENT MANUFACTURER WAS ABLE TO BE SUCCESSFULLY USED TO ACHIEVE TREATMENT WITHOUT A MISADMINISTRATION (DEFINED AS DELIVERING LESS THAN 75% OF THE DOSE IN THE WRITTEN DIRECTIVE) AND WITHOUT NONTARGET EMBOLIZATION OF THE RADIOEMBOLIZATION TO BOWEL. THE NATURE OF THE FAILURE HAS BEEN SEEN PREVIOUSLY WITH THE CATHETER - SPECIFICALLY, THE BALLOON INFLATION LUMEN COMMUNICATES WITH THE TRUE CATHETER LUMEN AND THE BALLOON DECOMPRESSES SPO

  Patient problems: Unintended Radiation Exposure

  MAUDE report 18055595 ↗
• InjuryNov 1, 2023

  PATIENT UNDERGOING YTTRIUM-90 RADIOEMBOLIZATION OF LIVER METASTASIS FROM RECTAL CANCER. BALLOON OCCLUSION CATHETER DEPLOYED IN RIGHT HEPATIC ARTERY OSTENSIBLY TO DIRECT RADIOACTIVE SPHERES TO THE TARGET AREA WHILE PREVENTING NONTARGET EMBOLIZATION TO BOWEL AND THE REMAINDER OF THE LIVER NOT CONTAINING TUMOR. TWO CONSECUTIVE SNIPER BALLOON MICROCATHETERS FAILED, THE FIRST BEFORE ANY RADIOACTIVE BEADS HAD BEEN ADMINISTERED THROUGH IT AND THE SECOND DURING ADMINISTRATION OF AN ALIQUOT OF RADIOACTIVE BEADS. REMOVING THE SECOND MICROCATHETER EXPOSED THE PATIENT TO THE POSSIBILITY OF REFLUX OF THE PARTICLES INTO THE GASTRODUODENAL ARTERY AND NONTARGET EMBOLIZATION TO THE BOWEL AND REMAINDER OF THE LIVER. ULTIMATELY, A THIRD BALLOON OCCLUSION MICROCATHETER BY DIFFERENT MANUFACTURER WAS ABLE TO BE SUCCESSFULLY USED TO ACHIEVE TREATMENT WITHOUT A MISADMINISTRATION (DEFINED AS DELIVERING LESS THAN 75% OF THE DOSE IN THE WRITTEN DIRECTIVE) AND WITHOUT NONTARGET EMBOLIZATION OF THE RADIOEMBOLIZATION TO BOWEL. THE NATURE OF THE FAILURE HAS BEEN SEEN PREVIOUSLY WITH THE CATHETER - SPECIFICALLY, THE BALLOON INFLATION LUMEN COMMUNICATES WITH THE TRUE CATHETER LUMEN AND THE BALLOON DECOMPRESSES SPO

  Patient problems: Unintended Radiation Exposure

  MAUDE report 18055574 ↗
• MalfunctionApr 16, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED PER HOSPITAL MEDWATCH REPORT #13450705 THAT THE HYDROPHILIC COATING ON THE CATHETER FAILED. THE CATHETER WAS REMOVED AND REPLACED WITH ANOTHER OF THE SAME WITH NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14131795 ↗
• MalfunctionApr 16, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED PER HOSPITAL MEDWATCH REPORT # (B)(4): DEFECTIVE COATING ON THE CATHETER CAUSED A KINK IN THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14131789 ↗
• MalfunctionMay 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING PROSTATE ARTERY EMBOLIZATION PROCEDURE, THE DEVICE BALLOON WAS INFLATED IN 2MM VESSEL, THEN EMBOLIZED WITH 40-80 EMBOZINE TO STASIS. THE BALLOON WOULD NOT DEFLATE AFTER SEVERAL ATTEMPTS. THE DR. DECIDED TO OVER INFLATE TO BURST. THE DR. THEN PULLED BACK THE DEVICE AND THERE WAS INTIMA DAMAGE TO WALL OF VESSEL. THE DR. THEN EMBOLIZED PROXIMAL TO INJURY WITH COILS TO STOP FLOW INTO INTIMA OF VESSEL WALL.

  Patient problems: Intimal Dissection

  MAUDE report 10070011 ↗