VIPER 286710500Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034213897), received between Oct 25, 2019 and Oct 19, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 19, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE FRONT PART OF THE CANNULATED TAP BROKE OFF DUE TO HEAVILY SCLEROTISED PEDICLE. ALL FRAGMENTS WERE REMOVED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF ONE HOUR. PATIENT STATUS WAS GOOD. THIS REPORT IS FOR A 5MM SELF DRILLING DUAL LEAD CA. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12660045 ↗
• MalfunctionOct 25, 2019Break; Break

  LIBERTAS: IT WAS REPORTED THAT ON (B)(6) 2019, THE 6MM DUAL-LEAD TAP WAS FOUND TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9240715 ↗