Mach1™ H74934356520Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729350781), received between Aug 7, 2019 and Aug 7, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT MAIN ARTERY. A MACH1 GUIDING CATHETER WAS SELECTED FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE. A STENT WAS PLACED FOLLOWED BY BALLOONING. THE BALLOON EXPANDED AFTER SLIGHTLY ENTERING INTO THE GUIDING CATHETER. IT WAS NOTED THAT THE TIP OF THE GUIDING CATHETER GOT SEPARATED, AND IT FLOWED INTO THE DIRECTION OF THE LEFT CIRCUMFLEX ARTERY. FLUOROSCOPY WAS PERFORMED AND IT WAS CONFIRMED THAT THE TIP DETACHED. THE PHYSICIAN TRIED TO RETRIEVE THE TIP WITH A BALLOON CATHETER, BUT IT COULD NOT BE RETRIEVED. IT WAS SUCCESSFULLY REMOVED WITH GOOSE NECK SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE BALLOON CATHETER USED IN THE PROCEDURE WAS A NON-BSC BALLOON CATHETER AND THE PATIENT'S CURRENT CONDITION IS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8869893 ↗