RapidCross™ A14BX040120170Recalls & reported problems
Covidien LP · PTA A14BX040120170 RAPIDCROSS V04 · 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 00763000111311), received between Nov 28, 2022 and Nov 28, 2022 — 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
- Leak/Splash1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 28, 2022Burst Container or Vessel; Leak/Splash; Material Deformation; Burst Container or Vessel; Leak/Splash; Material Deformation
A PHYSICIAN WAS USING A RAPIDCROSS PTA BALLOON DURING A CROSS-OVER ANGIOPLASTY OF THE RIGHT FEMORAL-POPLITEAL ARTERY. USE OF GUIDES AND PROBES OF SIZE 0.014" AS WELL AS DILATION BALLOONS DUE TO THE PATIENT'S CALCIFIED ARTERY. THE RAPIDCROSS WAS USED TO PERFORM DILATION DURING THE RECANALIZATION. MANEUVER PERFORMED UNDER RADIOLOGICAL CONTROL, AS A RESULT OF USING AN IODINE CONTRAST PRODUCT THE SURGEON NOTICED THAT THE BALLOON WAS PIERCED AND THAT THERE WAS A CRACK. THE DECISION WAS MADE TO REPLACE THIS BALLOON WITH A ANOTHER FROM THE SAME LABORATORY WHICH WAS SUCCESSFULLY USED. NO PATIENT INJURY REPORTED FOR THE PATIENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15868510 ↗
Other Catheter, angioplasty, peripheral, transluminal devices
- Coyote™ ES H74939135152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal879 reports
- Coyote™ ES H74939135204010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal585 reports
- Coyote™ ES H74939135202010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal437 reports
- Coyote™ ES H74939135304010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal384 reports
- Coyote™ ES H74939135404010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal293 reports
- Coyote™ ES H74939134152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal279 reports
- Coyote™ H74939185202210Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal200 reports
- Coyote™ ES H74939135254010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal127 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page