Sublime™ 014 Rx PTA Balloon Dilatation Catheter SRA-DC14-20150Recalls & reported problems
Creagh Medical Limited · 014 Radial Catheter 2mm 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 05391525783673), received between Dec 3, 2024 and Dec 3, 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
- Loss of or Failure to Bond1
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.
InjuryDec 3, 2024Loss of or Failure to Bond; Fracture; Loss of or Failure to Bond; Fracture
THE BALLOON CATHETER USED DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE OF A CALCIFIED TIBIAL ARTERY. THE BALLOON WAS INFLATED THREE TIMES. ON THE THIRD INFLATION, THE BALLOON RUPTURED. THE BALLOON WAS INFLATED TO 8ATM, 4ATM, AND 6ATM RESPECTIVELY. THE PHYSICIAN ATTEMPTED TO REMOVE THE BALLOON. IN DOING SO, THE DISTAL PORTION OF THE BALLOON SEPARATED AND WAS LEFT IN THE PATIENT'S ARTERY. SEVERAL ATTEMPTS WERE MADE TO RETRIEVE THE BALLOON SEGMENT, ALL OF WHICH WERE UNSUCCESSFUL. THE PHYSICIAN WAS ABLE TO STENT THE ARTERY, ENSURING THE BALLOON SEGMENT WOULD NOT MIGRATE. THERE WAS NO FURTHER PATIENT HARM. THE PROCEDURE WAS DELAYED DUE TO THE UNSUCCESSFUL RETRIEVAL ATTEMPTS.
Patient problems: Foreign Body In Patient
MAUDE report 20839680 ↗
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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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