AngioDynamics 700-102648Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H7877001026480), received between Mar 6, 2017 and Mar 6, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K040989); they may or may not involve this specific model.

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 6, 2017Thermal Decomposition of Device; Thermal Decomposition of Device

  AS REPORTED ON TO ANGIODYNAMICS ON (B)(6) 2017: THE USER REPORTED TO ANGIODYNAMICS' SALES REP. THAT THEY HAD A PATIENT EXPERIENCE PAD BURNS ON THEIR THIGHS DURING AN RFA PROCEDURE. IT WAS REPORTED THAT THE DISPOSABLE DEVICE WAS DISCARDED BY THE USER AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Burn(s); Burn, Thermal

  MAUDE report 6382815 ↗
• InjuryMar 6, 2017Thermal Decomposition of Device; Thermal Decomposition of Device

  AS REPORTED ON TO ANGIODYNAMICS ON (B)(6) 2017: THE USER REPORTED TO ANGIODYNAMICS' SALES REP. THAT THEY HAD A PATIENT EXPERIENCE PAD BURNS ON THEIR THIGHS DURING AN RFA PROCEDURE. IT WAS REPORTED THAT THE DISPOSABLE DEVICE WAS DISCARDED BY THE USER AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Burn(s); Burn, Thermal

  MAUDE report 6381249 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040989. One submission often covers many models, so check the product and lot details in each record.

• Z-1675-2013 · Jun 11, 2013 · Terminated
  AngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF 700-101892. RITA Main Cables are indicated for use with the RITA RF Generators and RITA electrosurgical devices.