Sublime™ 014 Rx PTA Balloon Dilatation Catheter SRA-DC14-20100Recalls & reported problems
Creagh Medical Limited · 014 Radial Catheter 2mm x 100mm x 250cm · 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 05391525783666), received between May 9, 2024 and May 9, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 9, 2024Fracture; Fracture
THE BALLOON CATHETER WAS USED IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE WITH LEFT COMMON FEMORAL ARTERY (CFA) ACCESS. THE TARGET VESSEL WAS THE POSTERIOR TIBIAL ARTERY. THE BALLOON CATHETER WAS USED TO FINISH THE PROCEDURE. IT WAS NOTED THE TARGET VESSEL WAS HIGHLY CALCIFIED. THERE WAS NO REPORT OF RESISTANCE BEING ENCOUNTERED DURING ADVANCEMENT/REMOVAL. THE PHYSICIAN WAS A HIGH VOLUME PROVIDER AND CONFIRMED DEFLATION PRIOR TO REMOVAL. DURING REMOVAL, THE CATHETER SHAFT SEPARATED IN THE MID TO DISTAL PORTION OF THE SHAFT. THE DISTAL SEGMENT COULD NOT BE RETRIEVED FOLLOWING SEVERAL HOURS OF EFFORT. DUE TO THE LENGTH OF THE CATHETER OUTSIDE OF THE PATIENT, THE REMAINING CATHETER WAS KEPT STRAIGHT OR IN LARGE LOOPS. THE PHYSICIAN STATED THE MIDSHAFT JOINT WAS RETAINED IN THE PATIENT POPLITEAL ARTERY DURING THE PROCEDURE. THE PATIENT WAS TRANSFERRED TO A HOSPITAL AND PLACED ON HEPARIN OVERNIGHT. THE NEXT MORNING, AN ADDITIONAL OPEN AND CUT-DOWN PROCEDURE WAS PERFORMED TO SURGICALLY REMOVE THE DISTAL SEGMENT. THE BALLOON PORTION OF THE CATHETER WAS STILL CONNECTED TO THE SHAFT. NO FURTHER CATHETER SEGMENTS REMAINED. THERE WAS NO FURTHER PATIENT HARM.
Patient problems: Foreign Body In Patient
MAUDE report 19280215 ↗
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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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