RapidCross™ A14BX030210170 (UDI 00821684067642)Recalls & reported problems
Covidien LP · PTA A14BX030210170 RAPIDCROSS V03 · Class 2
All models of RapidCross (26)
Data updated Oct 18, 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 00821684067642), received between Sep 6, 2018 and Sep 6, 2018 — 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 18, 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.
MalfunctionSep 6, 2018Burst Container or Vessel; Burst Container or Vessel
PHYSICIAN USED A RAPIDCROSS FOR TREATMENT OF THE PATIENTS MID ANTERIOR TIBIAL ARTERY (ATA). IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT IS REPORTED A BALLOON LEAK/BURST OCCURRED AT AN INFLATION PRESSURE OF 8ATM, ON THE FIRST INFLATION WITH A NON-MDT INFLATION DEVICE. THE TECHNICIAN OBSERVED BLOOD INSIDE THE BALLOON. IT COULD NOT BE DETERMINED IF THIS WAS DUE TO A MICRO TEAR ON THE BALLOON OR IF BLOOD ENTERED THE BALLOON AFTER PULLING NEGATIVE PRESSURE AFTER THE FIRST INFLATION. NO DAMAGE WAS NOTED TO THE BALLOON UPON REMOVAL. A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7849896 ↗
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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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