Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-60080Recalls & reported problems
Creagh Medical Limited · 018 Radial RX PTA, 5Fr, 6.0 mm x 80 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 05391525786414), received between Sep 18, 2024 and Sep 18, 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
- Material Separation1
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.
InjurySep 18, 2024Fracture; Material Separation; Fracture; Material Separation
THE BALLOON CATHETER WAS USED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. RADIAL ANGIOPLASTY WAS PERFORMED IN ORDER TO AVOID AN OPEN PROCEDURE. THE SITE REPORTED THE BALLOON BURST AFTER INFLATION TO APPROXIMATELY 10 ATMS. THE PHYSICIAN WAS USING THE "KISSING BALLOON TECHNIQUE" FOR BIFURCATIONS. DURING REMOVAL, THE BALLOON CATHETER SHAFT SEPARATED FROM THE MAIN BODY NEAR THE RAPID EXCHANGE PORT DURING REMOVAL FROM A 6FR SHEATH. THE THOUGHT WAS THAT THE SITE DID NOT ALLOW FULL DEFLATION OF THE BALLOONS PRIOR TO PULLING BACK INTO THE SHEATH. THE PHYSICIAN HAD TO PERFORM A VESSEL CUTDOWN TO RETRIEVE THE SEPARATED SEGMENTS AND FINISH WITH ENDARTERECTOMY. THE SITE INDICATED THE BALLOONS SEPARATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND PROXIMAL POPLITEAL ARTERY. MULTIPLE ATTEMPTS AT DEFLATION WERE MADE. THE WIRE WAS NOT REMOVED. THE BALLOON SEPARATED APPROXIMATELY 10-20 CM FROM THE BALLOON MARKERBAND. THE FURTHER INTERVENTION OF ENDARTERECTOMY WAS REQUIRED FOR THE CALCIFIED ILIAC ARTERY AND BALLOON SEGMENT REMOVAL. BOTH BALLOON SEGMENTS WERE INTACT UPON REMOVAL. THE ENTIRE PROCEDURE LASTED APPROXIMATELY SEVEN HOURS WITH A FOUR HOUR DELAY DUE TO THE BALLOON SEPA
Patient problems: Foreign Body In Patient
MAUDE report 20248145 ↗
Other Catheter, Angioplasty, Peripheral, Transluminal devices
- Coyote™ ES H74939135152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal879 reports
- Coyote™ ES H74939135204010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal585 reports
- Coyote™ ES H74939135202010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal437 reports
- Coyote™ ES H74939135304010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal384 reports
- Coyote™ ES H74939135404010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal293 reports
- Coyote™ ES H74939134152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal279 reports
- Coyote™ H74939185202210Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal200 reports
- Coyote™ ES H74939135254010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal127 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page