Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-50060Recalls & reported problems
Creagh Medical Limited · 018 Radial RX PTA, 5Fr, 5.0 mm x 60 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 05391525786339), received between Sep 25, 2023 and Sep 25, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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
- Material Separation1
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.
MalfunctionSep 25, 2023Material Separation; Material Separation
THE BALLOON WAS USED DURING AN ANGIOPLASTY PROCEDURE. THE GUIDE SHEATH WAS INSERTED INTO THE SUPERFICIAL FEMORAL ARTERY (SFA) WITHOUT ISSUE. DURING BALLOON REMOVAL, THE BALLOON GOT STUCK INSIDE THE GUIDE SHEATH AND WOULD NOT PULL THROUGH. THE PHYSICIAN TRIED TO PULL, BUT THE SHEATH WAS REMOVING AT THE SAME TIME AS THE BALLOON. THE PHYSICIAN THOUGHT THE BALLOON WAS UNSTUCK, BUT ONCE REMOVED, THE BALLOON SEGMENT WAS NOT ATTACHED TO THE HUB SEGMENT. THE BALLOON SEGMENT (WHICH CONTAINED THE RAPID EXCHANGE (RX) JUNCTION) WAS STUCK IN THE GUIDE SHEATH. THE SEPARATED SEGMENT WAS RETRIEVED WITH REMOVAL OF THE GUIDE SHEATH. IT WAS NOTED THE PHYSICIAN CONFIRMED BALLOON DEFLATION UNDER FLUOROSCOPY. THERE WAS NO IMPACT TO PATIENT OUTCOME OR PATIENT HARM. THE REPORTED ISSUE RESULTED IN A PROCEDURE DELAY OF APPROXIMATELY 20 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17813957 ↗
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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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