RapidCross™ A14BX025080170Recalls & reported problems
Covidien LP · PTA A14BX025080170 RAPIDCROSS V04 · Class 2
All models of RapidCross (26)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000110796), received between May 11, 2020 and Nov 24, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (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 16, 2026.
Most reported problems
Device problems
- Burst Container or Vessel1
- Difficult to Open or Remove Packaging Material1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 24, 2022Burst Container or Vessel; Burst Container or Vessel
A PHYSICIAN WAS USING A RAPIDCROSS PTA BALLOON FOR THE TREATMENT OF AN UNKNOWN LESION IN THE DISTAL REGION OF THE POSTERIOR TIBIAL ARTERY. THE DEVICE WAS INFLATED USING THE EVEREST INFLATION DEVICE. IT WAS REPORTED THE BALLOON BURST/LEAKED AT 4 ATM. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15860008 ↗MalfunctionMay 11, 2020Difficult to Open or Remove Packaging Material; Material Twisted/Bent; Difficult to Open or Remove Packaging Material; Material Twisted/Bent
PHYSICIAN WAS USING RAPIDCROSS PTA BALLOON ALONG WITH NON MEDTRONIC 6FR SHEATH AND .014 GUIDE WIRE DURING PROCEDURE TO TREAT A LITTLE CALCIFIED LESION IN THE RIGHT MID POSTERIOR TIBIAL ARTERY WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL DIAMETER AND LESION LENGTH WERE 2.5MM AND 60MM RESPECTIVELY. A NON MEDTRONIC INFLATION DEVICE WAS USED TO INFLATE THE BALLOON. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUED IDENTIFIED. IT WAS REPORTED THAT DURING REMOVAL OF THE DEVICE FROM THE PROTECTIVE PACKAGING, THE CATHETER WAS TWISTED AT THE SHAFT. ANOTHER PTA BALLOON WAS USED TO COMPLETE THE PROCEDURE. WHEN THE DEVICE WAS RECEIVED FOR EVALUATION IT WAS NOTED THE DEVICE WAS USED IN THE PATIENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10042161 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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