Ballast 088 Long Sheath BALLAST100Recalls & reported problems
Balt USA LLC · The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide catheter/long sheath that is designed for facilitating the introduction of appropriately sized interventional devices into target blood vessels in the peripheral, coronary, and neuro vasculature. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818053022906), received between Mar 11, 2022 and Mar 11, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Peeled/Delaminated” (1 report).
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
Device problems
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2022Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT: "BALLAST 100, SOFIA 5F, TREVO 4MM AND TREVO TRAK 21 MICRO CATHETER WERE USED FOR A THROMBECTOMY RADIAL ACCESS CASE IN THE MCA, RIGHT ICA. BALLAST WAS IN THE RIGHT ICA (ACCESS FROM RIGHT RADIAL, THROUGH RIGHT SUBCLAVIAN, UP CCA AND INTO ICA). AS THE STENT WAS REMOVED THROUGH THE BALLAST, THE INNER LUMEN BRAIDING OF THE BALLAST DELAMINATED AND TANGLED IN THE STENT AND THE CLOT. NEEDED TO PUNCTURE THE BALLAST TO REACCESS WITH .014 GUIDE WIRE. POSSIBLE REASONING BEHIND THE DELAMINATION OF THE BALLAST BRAIDING DURING THE STENT REMOVAL PROCESS COULD BE ATTRIBUTED TO THE CURVATURE OF THE SUBCLAVIAN ARTERY. NO KINK AT ANY STAGE WAS SEEN."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13733247 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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