RapidCross™ A14BX030080170Recalls & reported problems
Covidien LP · PTA A14BX030080170 RAPIDCROSS V03 · Class 2
All models of RapidCross (26)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684067567), received between Jan 10, 2019 and Jan 10, 2019 — classified as 1 malfunction.
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
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 10, 2019Burst Container or Vessel; Burst Container or Vessel
PHYSICIAN ATTEMPTED TO USE A RAPIDCROSS PTA BALLOON WITH A NON-MEDTRONIC 7FR X45CM SHEATH TO TREAT A FIBROUS LESION WITH 50% STENOSIS IN THE MODERATELY TORTUOUS MID TIBIAL/POPLITEAL TRUNK. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. NEGATIVE PREP WAS PERFORMED. NO RESISTANCE WAS EXPERIENCED WHEN ADVANCING WITH THE DEVICE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT A PINHOLE BALLOON BURST OCCURRED DURING THE INFLATION OF THE DEVICE WITH A NON-MDT DEVICE AND ISOVUE CONTRAST AND HEPARINISED SALINE TO 2ATM. THE PROCEDURE WAS COMPETED USING ANOTHER 3X80 NANOCROSS BALLOON. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8235218 ↗
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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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