Mach1™ H749343566860Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729351986), received between Mar 28, 2019 and Dec 8, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025Nonstandard Device; Nonstandard Device

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 17NOV2025. IT WAS REPORTED THAT THE DEVICE WAS DEFECTIVE. A 6F MACH 1 WAS SELECTED FOR USE. DURING INSPECTION OF THE PULLED-OUT ITEMS, IT WAS NOTED THAT THE UNIT WAS MARKED AS DEFECTIVE. HOWEVER, THE DEVICE ANALYSIS REVEALED THAT THE SHAFT WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23743402 ↗
• MalfunctionJun 10, 2024Break; Positioning Problem; Break; Positioning Problem

  IT WAS REPORTED THAT THE DEVICE GOT SEPARATED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 6F MACH 1 CATHETER-GUIDE WAS SELECTED FOR USE. DURING THE PROCEDURE, A RESISTANCE WAS FELT, AND THE CATHETER COULD NOT BE ADVANCED TO THE DESIRED POSITION. EVENTUALLY THE CATHETER GOT SEPARATED IN THE OSTIUM OF DISTAL RCA. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19498189 ↗
• MalfunctionApr 30, 2021Contamination; Contamination

  IT WAS REPORTED THAT THE STERILITY OF THE DEVICE WAS COMPROMISED. A MACH1 CATHETER-GUIDE WAS DELIVERED AND UPON REMOVING FROM PACKAGING, THE STERILE PACKAGING OF THE PRODUCT WAS OPENED. NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11751016 ↗
• InjuryMar 28, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT VESSEL DISSECTION OCCURED. THE LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A ROTALINK ADVANCER, 1.25 MM ROTALINK BURR, 330 CM ROTAWIRE AND 6F MACH1 GUIDING CATHETER WERE SELECTED FOR USE. THE ROTAWIRE WAS GUIDED THROUGH A NON-BSC MICROCATHETER TO THE DISTAL END OF THE LESION IN THE PL BRANCH. IT WAS NOTED THAT IT WAS DIFFICULT TO GUIDE THE ROTAWIRE THROUGH THE LESION DUE TO THE OCCLUSION, SO THE WIRE WAS SPUN HEAVILY TO GET IT TO THE DISTAL POINT IN THE PL BRANCH. SUBSEQUENTLY, THE BURR WAS ADVANCED IN DYNAGLIDE MODE OVER THE ROTAWIRE WITHIN THE MACH1 GUIDE CATHETER BUT THERE WAS RESISTANCE APPROXIMATELY 20CM INTO THE GUIDING CATHETER. THE ROTAWIRE STARTED TO SPIN QUITE HEAVILY AND THE DISTAL TIP OF THE WIRE BROKE OFF WHILE THE BURR WAS STILL IN THE GUIDING AND RESULTED TO A LIMITED LOCAL DISSECTION. AS THE BURR WAS COMPLETELY STUCK WHILE BEING IN THE GUIDING CATHETER, THE BURR AND WIRE WERE RETIREVED BUT THE WIRE POSITION WAS LOST. AN ATTEMPT TO REWIRE THE LESION WAS DONE USING A NON-BSC WIRE WHICH WAS GUIDED THROUGH THE MICROCATHETER BUT THE WIRE BECAME STUCK IN THE DISSECTION. THE PROCEDURE WAS DISCONTINUED AND THE DISSECTION WAS GIVEN TIME TO HEAL; SAM

  Patient problems: Vascular Dissection

  MAUDE report 8460916 ↗