RapidCross™ A14BX040150170 (UDI 00763000757168)Recalls & reported problems
Medtronic, Inc. · PTA A14BX040150170 RAPIDCROSS V05 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000757168), received between Aug 4, 2026 and Aug 4, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Deflation Problem” (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.
Reports received per month
Most reported problems
Device problems
- Deflation Problem1
- Difficult to Remove1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 4, 2026Deflation Problem; Difficult to Remove
Physician was attempting to use Rapidcross along a wire (ASAHI cruise) and 6FR sheath (Terumo Destination 45cm) for patient treatment. Saline and contrast medium, half-and-half was used for inflation fluid. It was reported that deflation difficulties were discovered during the initial inflation phase and it was difficult to remove the device. As balloon deflation could not be performed, it was pulled into the sheath as is and removed together with the sheath while the balloon was contained within the sheath. The procedure was continued. No patient injury reported. Intervention performed: balloon was pulled into the sheath and explanted with the sheath.
Patient problems: Insufficient Information
MAUDE report 50132157 ↗
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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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