Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-30220Recalls & reported problems
Creagh Medical Limited · 018 Radial RX PTA, 5Fr, 3.0 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05391525786148), received between Oct 30, 2025 and Oct 30, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
- 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.
MalfunctionOct 30, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation
THE SUBLIME BALLOON CATHETER WAS USED DURING A LOWER EXTREMITY INTERVENTION VIA RIGHT RADIAL ACCESS TO TREAT AN OCCLUDED ANTERIOR TIBIAL ARTERY. THE PHYSICIAN REPORTED THAT MULTIPLE MANIPULATIONS OF THE DEVICE WERE REQUIRED TO ATTEMPT TO CROSS THE LESION. THE GUIDEWIRE WAS BELIEVED TO HAVE KINKED PROXIMAL TO THE LESION, WITHIN THE SUPERFICIAL FEMORAL ARTERY (SFA). UPON WITHDRAWAL OF THE BALLOON CATHETER, RESISTANCE WAS ENCOUNTERED AT THE LOCATION OF THE WIRE KINK. THE PHYSICIAN APPLIED GENTLE TRACTION, AT WHICH POINT THE BALLOON COMPONENT SEPARATED FROM THE CATHETER SHAFT AND REMAINED INSIDE THE VASCULATURE WHILE STILL ATTACHED TO THE GUIDEWIRE. A SECONDARY BALLOON CATHETER (JADE BALLOON) WAS SUBSEQUENTLY ADVANCED AND USED TO TRAP AND RETRIEVE THE SEPARATED BALLOON SEGMENT, ENABLING SUCCESSFUL REMOVAL OF THE DEVICE FROM THE PATIENT. THE PROCEDURE WAS PROLONGED DUE TO THE RETRIEVAL PROCESS (OVER AN HOUR), AND PEDAL ACCESS WAS REQUIRED TO COMPLETE TREATMENT OF THE TARGET VESSEL. THERE WAS NO REPORTED PATIENT HARM OR ADVERSE CLINICAL OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23430555 ↗
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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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