Ballast 088 Long Sheath BALLAST80Recalls & 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 00818053022883), received between Mar 30, 2026 and Mar 30, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Damaged by Another Device” (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.
Reports received per month
Most reported problems
Device problems
- Device Damaged by Another Device1
- Retraction Problem1
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 30, 2026Retraction Problem; Device Damaged by Another Device
IT WAS REPORTED THAT: "LVO PROCEDURE. BALLAST 80CM, RED 68, PHENOM 21,TREVO 4MMX41MM. PHYSICIAN TOOK BALLAST INTO PETROUS SEGMENT OF ICA, RED 68 AND PHENOM 21 INTO M1. THE TREVO WAS THEN ADVANCED INTO DISTAL M1 AND THE PHENOM 21 WAS THEN STRIPPED AWAY. THE RED 68 WAS ADVANCED TO PROXIMAL PORTION OF TREVO. THE TREVO AND RED 68 WERE THEN PULLED BACK IN TANDEM INTO THE BALLAST. THE TREVO WAS EXPOSED OUTSIDE OF THE RED 68. UPON THE RED 68 AND TREVO BEING PULLED INTO THE BALLAST THE MD FELT RESISTANCE. HE THEN HAD TO PULL THE ENTIRE SYSTEM INCLUDING THE BALLAST FROM THE BODY. UPON REMOVAL THERE WAS WIRE COMING OUT OF THE HUB OF THE BALLAST. HE WAS ABLE TO REMOVE THE RED 68 AND TREVO AND INSPECT THEM. THERE WAS NO NOTICEABLE DAMAGE TO EITHER. HE THEN PULLED A NEW BALLAST AND USED THE SAME RED 68 AND TREVO TO COMPLETE A 2ND PASS WITH NO ISSUE. " INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24716569 ↗
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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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