AngioDynamics 700-101731MRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H787700101731M0), received between Aug 10, 2020 and Nov 1, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2022Output Problem; Output Problem

  DEVICE 1 OF 2 ASSOCIATED WITH THIS EVENT: AN END USER REPORTED AN ISSUE WITH A 1500X(M) RF GENERATOR. AN END USER REPORTED AN ISSUE WITH A STARBURST XL 10CM LONG PROBE. PER THE TREATING PHYSICIAN'S ACCOUNT OF THE EVENT: USING CT IMAGE GUIDANCE, A JAMSHIDI WAS ADVANCED THROUGH THE OVERLYING SKIN AND CORTEX AND USED TO BIOPSY THE OSTEOID OSTEOMA. A RITA STARBURST XL DEVICE ADVANCED THROUGH THE TRACT INTO THE PATIENT'S OSTEOID OSTEOMA AND ITS ARRAYS WERE DEPLOYED IN THE LESION. THE STARBURST NEEDLE WAS CONNECTED TO THE RITA 1500X ELECTROSURGICAL RADIOFREQUENCY GENERATOR AND THE FOLLOWING SETTINGS WERE ENTERED: TARGET TEMPERATURE: 90'C POWER: 50WTIME: 6 MINUTES THE DEVICE WORKED FOR A MOMENT UNTIL POWER REACHED 6W, AT WHICH TIME THE FOLLOWING ERROR MESSAGE APPEARED ON THE GENERATOR: SYSTEM FAILURE 3 TURN POWER OFF THE GENERATOR WAS REBOOTED, AND THE SAME ERROR MESSAGE OCCURRED AFTER POWER REACHED 6W. THE NEEDLE WAS CONNECTED TO A SECOND GENERATOR, AT WHICH TIME THE FOLLOWING ERROR MESSAGE APPEARED ON THE GENERATOR: UNRECOGNIZED DEVICE THE NEEDLE WAS CONNECTED TO THE FIRST GENERATOR AND MULTIPLE ADDITIONAL TROUBLESHOOTING STEPS WERE PERFORMED, INCLUDING REPOSITIONING THE GROUNDING PADS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15707764 ↗
• MalfunctionMay 10, 2021Communication or Transmission Problem; Activation, Positioning or Separation Problem; Communication or Transmission Problem; Activation, Positioning or Separation Problem

  AN ANGIODYNAMICS EMPLOYEE REPORTED AN ISSUE WITH THIS 1500X RFA GENERATOR. THE FOLLOWING WAS REPORTED: AFTER PLACING THE NEEDLE INTO THE KIDNEY AND PRESSING ON THE GENERATOR, THE GENERATOR DISPLAYED A MESSAGE STATING THAT THE THERMOPAD WAS NOT CONNECTED. AFTER DOUBLE CHECKING THE CONNECTIONS AND TAKING OUT AND THEN RECONNECTING, THE MACHINE ASKED FOR ANOTHER PURGE; HOWEVER, IN ORDER TO DO SO, THE NEEDLE HAS TO BE OUTSIDE OF THE BODY. THE RADIOLOGIST WAS NOT PREPARED TO TAKE THE NEEDLE OUT AS HE BELIEVED THERE WOULD BE A LARGE BLEED, SO THE NEEDLE WAS DISCONNECTED BUT LEFT IN-SITU AND ANOTHER NEEDLE WAS OPENED. AFTER PURGING THE NEW NEEDLE, AND PLACING ALONGSIDE THE ORIGINAL NEEDLE, A SIMILAR ISSUE WITH CONNECTIONS OCCURRED WITH A NEW THERMOPAD. THE GENERATOR DID NOT DISPLAY THE SAME "NO CONNECTION" MESSAGE, BUT SAID IT WAS POOR AND ONLY ONE TEMPERATURE READING CAME UP ON THE GENERATOR. ULTIMATELY, THE PROCEDURE WAS ABORTED DUE TO THIS EVENT. IT WAS INDICATED THE REPORTED RFA GENERATOR IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION. THIS EVENT MEETS THE CRITERIA A REPORTABLE ADVERSE EVENT; PATIENT SAFETY RISK AS TREATMENT WAS NOT PROVIDED, BUT PATIENT HAD BEEN S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797481 ↗
• MalfunctionAug 10, 2020Temperature Problem; Temperature Problem

  AN ANGIODYNAMICS DISTRIBUTOR REPORTED THAT A CUSTOMER HAD EXPERIENCED AN ISSUE USING AN RFA GENERATOR. THE PROVIDER REPORTED AN RFA GENERATOR TEMPERATURE ISSUE WHEN ATTEMPTING TO TREAT A CHILD'S OSTEOID OSTEOMA OF THE LOWER TIBIA. A UNIBLATE PROBE WAS BEING USED FOR THIS PROCEDURE. IT WAS REPORTED THAT THE RFA GENERATOR WOULD NOT HEAT PAST 30 DEGREES, GOALMOUTH THE TARGET TEMPERATURE WAS SET AT 90 DEGREES. THE CONNECTIONS WERE VERIFIED TO BE CORRECT, THE UNIT WAS DETECTING THE PROBE, AND THE DISPLAY SHOWED THE RF WAS ABLE TO BE STARTED, PATIENT WAS SEDATED AND PROBE WAS PLACED. WHEN ATTEMPTING TO ABLATE AFTER THE NEEDLE WAS PLACED, THE UNIT WAS SHOWN NOT TO BE HEATING, AND THE MESSAGE " INFUSING POWER IN 10 SEC " AND LOOP WAS DISPLAYED. THE PROCEDURE WAS ABORTED DUE TO THIS EVENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. AS THE PATIENT HAD BEEN SEDATED AND TREATMENT WAS NOT PROVIDED, THIS EVENT MEETS THE CRITERIA OF A REPORTABLE EVENT. IT WAS INDICATED THAT THE REPORTED RFA GENERATOR IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10387137 ↗

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.