Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-50040Recalls & reported problems
Creagh Medical Limited · 018 Radial RX PTA, 5Fr, 5.0 mm x 40 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 05391525786322), received between Aug 12, 2025 and Aug 12, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (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
- 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.
MalfunctionAug 12, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
THE SUBLIME BALLOON CATHETER WAS USED IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. THE SITE REPORTED PART OF THE BALLOON BROKE OFF AND BECAME STUCK IN THE SHEATH DURING REMOVAL. THE ENTIRE BALLOON WAS REMOVED WITHOUT ISSUE. THE PROVIDED IMAGE INDICATED THE BALLOON BROKE NEAR THE APPROXIMATE REGION OF THE RAPID EXCHANGE (RX) PORT. THE PATIENT ANATOMY WAS REPORTED TO BE VERY STENOTIC AND TORTUOUS. THE PHYSICIAN DID NOT CONFIRM BALLOON DEFLATION PRIOR TO REMOVAL AND THOUGHT THIS MAY HAVE CAUSED THE REPORTED ISSUE. THE BALLOON WAS CONFIRMED TO NOT BE FULLY DEFLATED. THE REPORTED ISSUE RESULTED IN A PROCEDURE DELAY OF APPROXIMATELY TEN MINUTES. THE INCIDENT OCCURRED DURING THE END OF THE PROCEDURE. THE CASE WAS COMPLETED WITHOUT INCIDENT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22786638 ↗
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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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