Ballast 088 Long Sheath BALLAST90Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00818053022890), received between May 22, 2019 and Oct 26, 2021 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 18, 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.

• InjuryOct 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT: "(B)(6) FEMALE, THROMBECTOMY PATIENT. WENT RADIAL (INFUSE COCKTAIL THROUGH 6F SHEATH, THEN EXCHANGE TO BALLAST) AND STARTED EXPERIENCING VASOSPASM. THEN WENT FEMORAL AND GAVE COCKTAIL; NITRO, VERAPAMIL & CARDIAC LIDO (WAITED AN HOUR) TRIED SEVERAL OTHERS. TRIED SEVERAL TECHNIQUES AND FINALLY HAD VASCULAR REMOVED." FOLLOW UP 29SEP2021: "I ASKED IF THERE WAS ANY MAJOR INJURY FROM THIS AND THEY SAID THE ARM WAS SAVED BUT THERE WAS AN ARM BYPASS DONE TO REMOVE THE SHEATH." "NO, NO REPORTED MALFUNCTION. THEY THINK THE PATIENT JUST HAD SEVERE VASOSPASM, WHICH CAUSED IT." "THE PATIENT DID HAVE TO GO TO SURGERY TO HAVE AN ARM BYPASS DONE TO REMOVE THE SHEATH."

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 12701423 ↗
• MalfunctionSep 27, 2021Fracture; Fracture

  NOTICE OF COMPLAINT RECEIVED VIA LETTER FROM FDA ON 31AUG2021. UF/IMPORTER REPORT # (B)(4): IT WAS REPORTED THAT: "WHEN THE PROCEDURE WAS OVER, THE BALLAST 088 LONG SHEATH (BALLAST90) WAS BEING REMOVED FROM THE RADIAL ARTERY OF THE PATIENT WHEN THE ARTERY DEVELOPED SPASM. WHILE BEING REMOVED, THE CATHETER BROKE AND A FRAGMENT OF THE CATHETER WAS LEFT INTRAVASCULARLY INSIDE THE RADIAL ARTERY OF THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 12537675 ↗
• MalfunctionApr 23, 2021Break; Break

  IT WAS REPORTED THAT: "TRIED GAINING ACCESS WITH BALLAST VIA RADIAL ACCESS AND DILATOR TIP WAS NOT SMOOTH. VESSEL WAS BIG ENOUGH FOR BALLAST BUT DUE TO NON SMOOTH TIP, DILATOR CAUGHT ON RADIAL ARTERY. AS HE WITHDREW THE SHEATH (NEEDED TO IMPART FORCE TO REMOVE), THE TIP SHEARED OFF. NO ADVERSE PATIENT IMPACT." FOLLOW UP RECIEVED BY SALE REPRESENTATIVE ON 23-APR-2021 CONFIRMED THAT DEVICE BROKE INSIDE VESSEL AND WAS SAFETLY RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11720737 ↗
• MalfunctionSep 20, 2019Fracture; Fracture

  IT WAS REPORTED THAT: "DR. (B)(6) WAS PERFORMING A BASILAR ARTERIAL THROMBECTOMY IN AN ACUTE STROKE CASE. HE USED THE BALLAST 90 THROUGH THE RADIAL ARTERY TO ACCESS THE VERTEBRAL ARTERY. WHEN REMOVING THE BALLAST POST THROMBECTOMY THE EXPERIENCE A LARGE AMOUNT OF FRICTION. THIS FRICTION RESULTED IN THE BALLAST TIP FRACTURING OFF AND REMAINING IN THE RADIAL ARTERY. THE PATIENT REQUIRED VASCULAR RESECTION FOR REMOVAL AND REPAIR OF THE RADIAL ARTERY. THE PHYSICIAN NOTICE A LARGE AMOUNT OF UNKNOWN CALCIFICATION IN THE RADIAL ARTERY DURING THE RESECTION. HE BELIEVES THE LARGE AMOUNT OF FRICTION ON REMOVAL OF THE BALLAST WAS CREATED BY THIS CALCIFICATION."

  Patient problems: Thrombosis

  MAUDE report 9098723 ↗
• InjuryMay 22, 2019Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT: "FIRST TIME USE OF BALLAST 90 IN AN AVM PATIENT. DR. (B)(6) ACCESSED THE RIGHT INTERNAL CAROTID BUT COULDN'T GET THE BALLAST TO MOVE INTO THE HORIZONTAL PETROUS SEGMENT OVER A .035 EXCHANGE WIRE. HE THEN ACCESSED THE LEFT INTERNAL CAROTID WITH A .038 GLIDE WIRE AND AGAIN THE BALLAST WOULD NOT TRACK INTO THE HORIZONTAL PETROUS SECTION. HE ALSO TRIED TO ADVANCE OF THE SCEPTER BALLOON 4X11 AND IT STILL WOULDN'T MOVE INTO THE HORIZONTAL PETROUS SECTION. THAT EVENING THE PATIENT EXPERIENCED DIFFUSE SHOWERING OF EMBOLI IN BOTH HEMISPHERES. "

  Patient problems: Embolus

  MAUDE report 8634466 ↗