Sublime™ 014 Rx PTA Balloon Dilatation Catheter SRA-DC14-35150Recalls & reported problems
Creagh Medical Limited · 014 Radial Catheter 3.5mm x 150mm 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 05391525783888), received between Mar 18, 2024 and Mar 18, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Failure to Deflate” (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
- Failure to Deflate1
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.
InjuryMar 18, 2024Failure to Deflate; Failure to Deflate
THE BALLOON WAS USED DURING AN ATHERECTOMY PROCEDURE THROUGH THE LEFT RADIAL ARTERY. THE PHYSICIAN PERFORMED AND ANGIOGRAM WITH DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) ATHERECTOMY USING A COMPETITOR'S LASER CATHETER TECHNOLOGY. UPON CONCLUSION OF THAT THERAPY, THE BALLOON WAS USED. THE BALLOON WAS DELIVERED TO THE TARGET LESION AND INFLATED WITHOUT ISSUE. DURING REMOVAL, THE BALLOON COULD NOT BE DEFLATED. SEVERAL TECHNIQUES WERE ATTEMPTED WITHOUT RESOLUTION. THE PHYSICIAN DECIDED TO USE A 21G NEEDLE TO POP THE BALLOON AND REMOVE. THE ISSUE OCCURRED AFTER THE INITIAL INFLATION THAT INTENDED TO BE INFLATED FOR APPROXIMATELY 30 SECONDS. THE BALLOON WAS INFLATED TO 6ATM. THE TORTUOSITY WAS REPORTED AS NORMAL. TROUBLESHOOTING INCLUDE MULTIPLE DEFLATION ATTEMPTS WITH THE INFLATOR, MANUAL PULL BACK WITH A SYRINGE ON SIDE, AND MANUAL PULL BACK DIRECT FROM THE BALLOON. THE PHYSICIAN ALSO INSERTED A GUIDEWIRE THROUGH THE BALLOON AND APPLYING MANUAL PRESSURE TO THE OUTSIDE OF THE PATIENT'S LEG TO POP. THE REPORTED ISSUE RESULTED IN A PROCEDURE DELAY OF APPROXIMATELY 25 MINUTES. THERE WAS NO FURTHER PATIENT HARM. THERE WAS NO FURTHER PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18927266 ↗
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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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