Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-20080Recalls & reported problems
Creagh Medical Limited · 018 Radial RX PTA, 5Fr, 2.0 mm x 80 mm, 220 cm · 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 05391525785943), received between May 14, 2025 and May 14, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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
- Deformation Due to Compressive Stress1
- Difficult to Advance1
- Loss of or Failure to Bond1
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.
MalfunctionMay 14, 2025Loss of or Failure to Bond; Deformation Due to Compressive Stress; Difficult to Advance; Loss of or Failure to Bond; Deformation Due to Compressive Stress; Difficult to Advance
THE SITE REPORTED THE BALLOON CATHETER BROKE IN THE PATIENT'S BODY PRIOR TO INFLATION. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED. THE BALLOON CATHETER SHAFT BROKE PROXIMAL TO THE RAPID EXCHANGE (RX) PORT. THE ISSUE OCCURRED AFTER THE FIRST INFLATION. AFTER DEFLATION, THE CATHETER WAS ADVANCED FURTHER DISTALLY, THROUGH THE LESION AND CALCIFICATION. IT WAS NOTED RESISTANCE WAS FELT. IT WAS AT THIS TIME, THE SHAFT BROKE. THE COMPLETE BALLOON CATHETER WAS ABLE TO BE REMOVED. THE ISSUE HAPPENED AT THE CONCLUSION OF THE PROCEDURE. THE SUBLIME BALLOON WAS USED AFTER OTHER BALLOONS COULD NO CROSS THE LESION. THE PHYSICIAN WAS UNABLE TO RECROSS THE LESION WITH A GUIDEWIRE UPON BALLOON REMOVAL. THIS WAS WHERE THE PROCEDURE CONCLUDED. THERE WAS NO PATIENT HARM OR PROCEDURE DELAY DUE TO THE SHAFT BREAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22023505 ↗
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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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