Mach1™ M001196660Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729403654), received between Aug 1, 2019 and Apr 12, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Unsealed Device Packaging” (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.

• MalfunctionApr 12, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DEVICE STERILITY WAS COMPROMISED. THE TARGET LESION WAS LOCATED AT THE RENAL ARTERY. A MACH1 GUIDE CATHETER WAS SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT THE INNER PACKAGING OF THE DEVICE WAS DAMAGED, AND GAS WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT CATHETER SHOWED NO DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16724186 ↗
• MalfunctionAug 1, 2019Contamination; Unsealed Device Packaging; Contamination; Unsealed Device Packaging

  IT WAS REPORTED THAT THE DEVICE STERILITY WAS COMPROMISED. THE TARGET LESION WAS LOCATED IN THE RENAL ARTERY. A MODEL 6F PV MACH 1 WAS SELECTED FOR USE TO VIEW THE TARGET LESION. DURING UNPACKING, IT WAS NOTED THAT THERE WAS AIR LEAKAGE AND THE DEVICE WAS NOT STERILE. THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8851249 ↗