Mach1™ H749343566620Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729351863), received between Mar 5, 2021 and Mar 5, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DISSECTIONS OCCURRED AND ADDITIONAL INTERVENTION WAS REQUIRED. TWO 6F MACH1 GUIDE CATHETERS WERE SELECTED FOR USE IN PROCEDURES. THE DEVICES DID NOT SUFFICIENTLY SUPPORT BALLOON OR STENT ADVANCEMENT IN SMALL, TOUGH LESIONS AND TORTUOUS VEINS. THE DEVICES LOST THEIR HARDNESS OVER TIME. IN SOME CASES, THE GUIDE CATHETER STUCK TO THE INSERTION SITE SHEATH AND WOULD MOVE THE SHEATH DURING CATHETER MOVEMENTS. IT WAS OBSERVED TO LACK INNER DIAMETER SUITABILITY TO PRACTICALLY SUPPORT EASY DOUBLE BALLOON OR JOINT STENT-BALLOON ADVANCEMENT. ADDITIONAL STEPS, SUCH AS EMBEDDING THE CATHETER FURTHER INTO THE CORONARY ARTERY, WERE REQUIRED AS SUFFICIENT SUPPORT WAS NOT PROVIDED FOR SUCH CATHETER ISSUES. ADDITIONALLY, THE DEVICES HAVE RESULTED IN DISSECTIONS, PROLONGATION OF PROCEDURES, USE OF ADDITIONAL BALLOONS OR STENTS, OPERATION FAILURES, AND VITAL COMPLICATIONS BECAUSE THE BALLOON OR STENT COULD NOT BE ADVANCED. IT WAS FURTHER REPORTED THAT THE DISSECTION OCCURRED DURING THE STENT PASSING STAGE. THE DISSECTED AREA WAS COVERED. THE PROCEDURE WAS COMPLETED WITH ANOTHER GUIDE CATHETER. THE PATIENT'S STATUS WAS STABLE.

  Patient problems: Vascular Dissection

  MAUDE report 11419266 ↗
• InjuryMar 5, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DISSECTIONS OCCURRED AND ADDITIONAL INTERVENTION WAS REQUIRED. TWO 6F MACH1 GUIDE CATHETERS WERE SELECTED FOR USE IN PROCEDURES. THE DEVICES DID NOT SUFFICIENTLY SUPPORT BALLOON OR STENT ADVANCEMENT IN SMALL, TOUGH LESIONS AND TORTUOUS VEINS. THE DEVICES LOST THEIR HARDNESS OVER TIME. IN SOME CASES, THE GUIDE CATHETER STUCK TO THE INSERTION SITE SHEATH AND WOULD MOVE THE SHEATH DURING CATHETER MOVEMENTS. IT WAS OBSERVED TO LACK INNER DIAMETER SUITABILITY TO PRACTICALLY SUPPORT EASY DOUBLE BALLOON OR JOINT STENT-BALLOON ADVANCEMENT. ADDITIONAL STEPS, SUCH AS EMBEDDING THE CATHETER FURTHER INTO THE CORONARY ARTERY, WERE REQUIRED AS SUFFICIENT SUPPORT WAS NOT PROVIDED FOR SUCH CATHETER ISSUES. ADDITIONALLY, THE DEVICES HAVE RESULTED IN DISSECTIONS, PROLONGATION OF PROCEDURES, USE OF ADDITIONAL BALLOONS OR STENTS, OPERATION FAILURES, AND VITAL COMPLICATIONS BECAUSE THE BALLOON OR STENT COULD NOT BE ADVANCED. IT WAS FURTHER REPORTED THAT THE DISSECTION OCCURRED DURING THE STENT PASSING STAGE. THE DISSECTED AREA WAS COVERED. THE PROCEDURE WAS COMPLETED WITH ANOTHER GUIDE CATHETER. THE PATIENT'S STATUS WAS STABLE.

  Patient problems: Vascular Dissection

  MAUDE report 11419234 ↗