CrossBoss™ H749M2000A0Recalls & reported problems
Boston Scientific Corporation · Catheter · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729837510), received between Nov 7, 2019 and Aug 6, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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
- Device Contamination with Chemical or Other Material1
- Unsealed Device Packaging1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2020Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT THE STERILE PACKAGING WAS PARTLY OPENED. A CROSSBOSS RE-ENTRY DEVICE WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE STERILE PACKAGING WAS PARTLY OPENED AT THE TOP CORNER. THE DEVICE WAS NOT USED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10373931 ↗MalfunctionNov 7, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A FOREIGN MATERIAL WAS PRESENT IN THE DEVICE. THE TARGET LESION WAS LOCATED IN THE TOTALLY OCCLUDED RIGHT CORONARY ARTERY. A CROSSBOSS RE-ENTRY DEVICE WAS SELECTED FOR USE. DURING THE PROCEDURE INSIDE THE PATIENT, SEVERAL WIRES WERE TRIED TO ADVANCED THROUGH THE CROSSBOSS BUT WAS UNABLE TO ADVANCE TO THE CROSSBOSS. THE CROSSBOSS WAS THEN TAKEN OUT AND WHEN FLUSHING WAS PERFORMED, A BLUE MATERIAL THAT WAS PARTICLE OF A BLUE STERILE TOWEL FLUSHED OUT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9289884 ↗
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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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