RapidCross™ A14BX040210170Recalls & reported problems
Covidien LP · PTA A14BX040210170 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 00821684067963), received between Mar 20, 2018 and Mar 20, 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
- Detachment of Device or Device Component1
- Difficult to Remove1
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.
MalfunctionMar 20, 2018Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component
THE PHYSICIAN WAS ATTEMPTING TO USE A RAPID CROSS BALLOON TO TREAT A SEVERELY CALCIFIED CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE DISTAL LEFT TIBIAL/POPLITEAL TRUNK AND PERITONEAL ARTERY. THE ARTERY DIAMETER WAS 3 MM WITH A SEVERE DEGREE OF TORTUOSITY. THE PATIENT¿S ANATOMY WAS DESCRIBED AS VERY STEEP WITH A HIGHLY TORTUOUS ILIAC AND ILIAC HORN. THE DEVICE WAS REMOVED FROM ITS PACKAGING AND INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED AS PER THE IFU. A 7 FRENCH NON-MEDTRONIC SHEATH WAS USED IN THE PROCEDURE AND A NON-MEDTRONIC GUIDEWIRE. NO EMBOLIC PROTECTION WAS USED. THE PHYSICIAN WAS MET WITH SEVERE RESISTANCE DURING ADVANCEMENT AND THE BALLOON COULD NOT CROSS THE LESION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT AND NO EXCESSIVE FORCE WAS USED. THE DEVICE WAS INFLATED USING A MEDTRONIC INFLATION DEVICE. THE BALLOON WAS REPORTED TO HAVE BURST. UPON REMOVAL THROUGH THE SHEATH, THE BALLOON GOT STUCK AND WOULD NOT PASS THROUGH THE SEVERELY TORTUOUSLY BENT SHEATH. THE PHYSICIAN PULLED AND THE SHAFT OF THE BALLOON BECAME DETACHED AND TRAPPED IN THE DISTAL PART OF THE SHEATH. THE SHEATH HAD TO BE REMOVED ALONG WITH BALLOON LODGED INSIDE IT. ALL COMPONENTS
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7354008 ↗
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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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