Balloon Catheter BC0420C-ID-700Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00842429103401), received between Aug 5, 2020 and Apr 25, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT A SCEPTER C BALLOON 4 X 20 COULD NOT BE DEFLATED DURING A BALLOON ASSISTED COILING OF RUPTURED LARGE (L) SUPERIOR HYPOPHYSIAL ARTERY ANEURYSM PROCEDURE. DIFFICULT ACCESS. HAD TO LOOP THE CATHETER IN THE ANEURYSM TO GET THE OUTFLOW. INFLATED THE BALLOON IN MCA TO GET RID OF THE LOOP. BALLOON STAYED INFLATED DESPITE USING 60 CC SYRINGE. COULD HAVE KINKED THE CATHETER WITH THAT MANEUVER. PERHAPS THE GUIDEWIRE SHOULD HAVE BEEN LEFT IT IN THE CATHETER. BALLOON WAS PREP THE USUAL WAY AND DEFLATED NORMALLY PRIOR TO INSERTION. ADDITIONALLY REPORTED: LOOPED BALLOON INSIDE ANEURYSM TO FIND OUTFLOW AND INFLATED IN MCA AND STRAIGHTENED OUT LOOP. BALLOON INFLATED BUT WOULD NOT DEFLATE. BALLOON INFLATED AND DEFLATED WELL ON TESTING IN PETROUS ICA. BUT AFTER GETTING DISTAL TO ANEURYSM (TORTUOUS ANATOMY) BALLOON INFLATED BUT WOULD NOT DEFLATE. THE CASE WAS COMPLETED WITH COILS. THE PATIENT WAS REPORTED TO BE DOING GOOD. NO HARM DONE ON PATIENT. THE PATIENT IS CLINICALLY WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21914621 ↗
• MalfunctionAug 23, 2024Material Rupture; Material Rupture

  AS REPORTED: THE BALLOON WAS DEFLATED WITH SALINE AND RUPTURED WHEN THE PHYSICIAN INFLATED IT WITH CONTRAST-MIXED SALINE. ACCORDING TO THE PHYSICIAN, WHEN THE BALLOON RUPTURED, THERE WAS A SUDDEN LOSS OF PRESSURE. THE PHYSICIAN TEMPORARILY STOPPED THE PROCEDURE AND REMOVED THE DEVICE TO ENSURE THE SAFETY OF THE PATIENT. THE PATIENT IS UNDER OBSERVATION, WITH NO FURTHER CLINICAL CHANGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20045631 ↗
• MalfunctionJul 21, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING THE PROCEDURE, A SCEPTER C BALLOON RUPTURED DURING INFLATION. THERE WAS NO REPORTED INTERVENTION OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15080736 ↗
• MalfunctionOct 19, 2021Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT DURING A PROCEDURE, IT WAS NOT POSSIBLE TO DEFLATE A SCEPTER C BALLOON CATHETER. AFTER MULTIPLE ATTEMPTS, THE BALLOON DEFLATED. THE PATIENT IS REPORTED TO BE "DOING WELL." THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12661588 ↗
• MalfunctionOct 9, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED DURING THE PROCEDURE. THE DEVICE WAS REMOVED IN ITS ENTIRETY. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10659645 ↗
• MalfunctionAug 21, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON-ASSISTED COIL EMBOLIZATION WAS PERFORMED FOR AN INTERNAL CAROTID ARTERY ANEURYSM. DURING THE BALLOON INFLATION, THE BALLOON RUPTURED. THE BALLOON WAS REMOVED FROM THE PATIENT AND REPLACED WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION. THE PATIENT'S CURRENT CONDITION IS REPORTED TO BE "GOOD."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10439806 ↗
• MalfunctionAug 5, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING TREATMENT OF A RUPTURED ANEURYSM, THE BALLOON WAS INFLATED, WHICH IMMEDIATELY CONTROLLED BLEEDING. THE BALLOON CATHETER WAS LEFT IN PLACE FOR A "CERTAIN AMOUNT OF TIME." WHEN THE BALLOON WAS THEN CHECKED UNDER FLUOROSCOPY, THE BALLOON WAS NO LONGER INFLATED, APPEARING TO HAVE LOST ITS VOLUME DURING A TIME PERIOD WHEN FLUOROSCOPY WAS NOT ACTIVATED. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THE BALLOON DEFLATION. THE PATIENT IS REPORTED TO BE "OK."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10370661 ↗