RITA 700102649Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H7877001026490), received between Jul 11, 2016 and Apr 1, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Issue” (1 report).

1 other recall cover devices cleared under the same FDA submission (K031926); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN END USER REPORTED A PATIENT ISSUE WITH A THERMO PAD BLUE WHEN USED WITH A 25CM STARBURST XLIE W TUBE SET. DUE TO THE PATIENT HAVING METAL ROD IN THIGH BONE, ONLY ONE BLUE PACK RFA PAD WAS USED ON OPPOSITE LEG, WHILE THE SECOND PAD WAS ATTACHED TO DEVICE IN ORDER TO MAKE THE MACHINE WORK CORRECTLY. A BAG OF ICE WAS PLACED OVER THE PAD ON THE PATIENT'S LEG BEFORE PATIENT WAS DRAPED BY CIRCULATING NURSE. AN ABLATION OF 6-7CM LESION WAS COMPLETED WITH ELECTRODE AFTER PERFORMING ONE 6CM ABLATION AND TWO 4CM ABLATIONS ON THE LESION. IT WAS NOTED THAT THE GENERATOR DID LOSE POWER DUE TO A LOOSE POWER CORD, WHICH OCCURRED DURING HEATING TO TARGET TEMPERATURE. ULTIMATELY, POWER WAS RESTORED AND THE ABLATION WAS RESTARTED FROM STEP 1. NO ADVERSE REACTIONS WERE OBSERVED DURING OR AFTER POWER LOSS. AN ANGIODYNAMICS REP WAS PRESENT IN THE ROOM AND MONITORED THE PAD TEMP; ENSURING IT NEVER INCREASED HIGHER THAN 35 DEGREES CELSIUS. THE THERMOPADS WERE NOT REPLACED OR MOVED AFTER THE GENERATOR SHUTDOWN. THE ABLATION WAS SUCCESSFUL AND THE PATIENT WENT TO THE FLOOR. SHORTLY AFTER, THE END USER, IN THE OPERATING ROOM, REPORTED THAT THE PATIENT HAD A NICKEL SIZE BURN ON THEIR RIGHT THIGH ABOVE THE

  Patient problems: Burn(s)

  MAUDE report 13977653 ↗
• InjuryJan 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO ANGIODYNAMICS ON JANUARY 03, 2018: THIS MEDWATCH IS NOT TO REPORT A DEVICE MALFUNCTION, BUT TO REPORT AN ADVERSE PATIENT EFFECT. DURING AN RFA PROCEDURE, IT WAS NOTED THE PATIENT EXPERIENCED THERMO PAD BURNS AT THE SITE OF THE PAD PLACEMENT. THE PATIENT'S SKIN APPEARED BURNT AND BLISTERED. THE BURNS WERE TREATED WITH ICE PACKS. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Burn, Thermal

  MAUDE report 7205174 ↗
• InjurySep 7, 2016Thermal Decomposition of Device; Thermal Decomposition of Device

  AS REPORTED ON (B)(6) 2016 BY ANGIODYNAMICS TERRITORY MANAGER OS, " SKIN BURN IN THE AREA WHERE ONE OF THE RFA PADS WAS PLACED. BURN IS ON THE INNER THIGH (ANTERIOR) 5" LONG TOWARDS THE PATIENT'S KNEE AND 2" WIDE LATERAL TO MEDIAL."

  Patient problems: Burn(s); Burn, Thermal

  MAUDE report 5933334 ↗
• InjuryJul 11, 2016Device Issue; Device Issue

  AS REPORTED ON (B)(6) 2016 BY INTERNATIONAL TERRITORY MANAGER, PATIENT RECEIVED SKIN BURNS POST-PROCEDURE. NO FURTHER INFORMATION RECEIVED SO ASSUMING PATIENT WAS OKAY AND CUSTOMER CONTINUED TO US THE RFA EQUIPMENT(DIFFERENT LOT NUMBER OF THERMOPADS).

  Patient problems: Burn, Thermal; Skin Irritation

  MAUDE report 5781726 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031926. One submission often covers many models, so check the product and lot details in each record.

• Z-0087-04 · Oct 6, 2003 · Terminated
  RITA brand ThermoPad, Electrosurgical RF Generator and accessories Part Number: 700-102649