Mach1™ H74934358480Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729382775), received between Sep 3, 2018 and Sep 3, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Material Integrity 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.

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.

• InjurySep 3, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DECREASE IN BLOOD PRESSURE AND BRADYCARDIA OCCURRED. THE 99% STENOSED, 15MM IN LENGTH, 3.5MM IN DIAMETER TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY. A MACH 1 GUIDE CATHETER WAS SELECTED FOR USE. DURING PERCUTANEOUS CORONARY INTERVENTION (PCI), ABLATION WAS PERFORMED USING 1.75MM ROTALINK PLUS BURR OVER A ROTAWIRE. ABLATION WAS PERFORMED THREE TIMES AT 205,000 RPM FOR A DURATION OF 10 SECONDS WITHOUT STAYING IN ONE PLACE. HOWEVER, WHEN THE 1.75MM BURR WAS REMOVED INTO THE GUIDE CATHETER THE BLOOD PRESSURE DECREASED AND BRADYCARDIA OCCURRED. THE SYMPTOMS WERE IMPROVED BY DRUG ADMINISTRATION. ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE BLOOD PRESSURE DECREASE AND BRADYCARDIA MIGHT BE THE ABLATED DEBRIS THAT FLOWED TO THE PERIPHERY. THERE WAS SOME DAMAGE OBSERVED WITHIN THE INNER LUMEN OF THE GUIDE CATHETER, BUT THE PHYSICIAN DID NOT THINK THIS CONTRIBUTED TO THE PATIENT COMPLICATIONS. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THE PATIENT'S CURRENT CONDITION IS GOOD.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension

  MAUDE report 7840514 ↗