Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-40220Recalls & reported problems
Creagh Medical Limited · 018 Radial RX PTA, 5Fr, 4.0 mm x 220 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05391525786308), received between Sep 13, 2023 and Sep 13, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
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.
InjurySep 13, 2023Fracture; Fracture
THE DEVICE WAS USED FOR BALLOON ANGIOPLASTY OF THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE APPROXIMATE VESSEL DIAMETER WAS 4MM WITH A LESION LENGTH OF APPROXIMATELY 150MM. THE ESTIMATED LESION CALCIFICATION WAS APPROXIMATELY 80%. THE PHYSICIAN EXPERIENCED DIFFICULTY REMOVING THE DEVICE. REMOVAL WAS PERFORMED AFTER THE INITIAL PASS BY HOLDING NEGATIVE PRESSURE ON AN INFLATION DEVICE FOR APPROXIMATELY 5-10 SECONDS. DEFLATION WAS NOT CONFIRMED UNDER FLUOROSCOPY ONCE RESISTANCE WAS MET. THE PHYSICIAN "TUGGED PRETTY HARD" WHEN IT WAS NOTICED THE BALLOON WAS NOT MOVING UNDER FLUOROSCOPY DURING WITHDRAWAL. DURING THE REMOVAL PROCESS, THE SHAFT SEPARATED AT THE RAPID EXCHANGE (RX) PORT. THE INTRODUCER SHEATH NEEDED TO BE REMOVED WHEN THE BALLOON SEGMENT WAS SNARED BECAUSE THE BALLOON DID NOT DEFLATE ENOUGH TO PASS THROUGH THE SHEATH. ALL BALLOON SEGMENTS WERE RETRIEVED. AFTER REMOVAL, THE PHYSICIAN STILL NEEDED A 6MM BALLOON FOR THE PROXIMAL SFA SEGMENT. DUE TO REMOVING THE SHEATH, THE PHYSICIAN DECIDED TO GAIN FEMORAL ACCESS TO TREAT THE PROXIMAL SFA WITH A DRUG COATED BALLOON (DCB). THERE WAS NO FURTHER IMPACT TO PATIENT OUTCOME. THE REPORTED ISSUE RESULTED IN A PROCEDURE DELAY OF A
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17738534 ↗
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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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