Uniblate 700-103597Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H7877001035971), received between Apr 10, 2018 and Jan 29, 2019 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 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.

• MalfunctionJan 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ANGIODYNAMICS' DISTRIBUTOR REPORTED THAT A UNIBLATE RFA PROBE WAS UNABLE TO BE USED BY THEIR CUSTOMER, AS THE TIP WAS BROKEN. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. IT WAS REPORTED THAT THE DEVICE INVOLVED IN THE INCIDENT IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8286927 ↗
• MalfunctionJan 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ANGIODYNAMICS' DISTRIBUTOR REPORTED THAT A UNIBLATE RFA PROBE WAS UNABLE TO BE USED BY THEIR CUSTOMER, AS THE TIP WAS BROKEN. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. IT WAS REPORTED THAT THE DEVICE INVOLVED IN THE INCIDENT IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8286923 ↗
• InjuryApr 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MEDWATCH IS NOT TO REPORT A DEVICE MALFUNCTION, BUT TO REPORT AN ADVERSE PATIENT EFFECT. THERE WAS NO REPORT OF A DEVICE MALFUNCTION DURING THE PROCEDURE. AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2018: PATIENT RECEIVED A SKIN BURN DURING UNIBLATE CASE AT PROBE/INTRODUCER ENTRY SIGHT. PATIENT WAS TAKEN TO (B)(6) AND A WOUND CARE NURSE WAS CALLED TO ASSESS THE BURN. PER THE TREATING PHYSICIAN, HE FELT IT THE BURN) WOULD HEAL, BUT THAT THE TISSUE WAS NECROSED AROUND THE ENTRY SIGHT. THE LOCATION OF THE BURN WAS THE SKIN ABOVE THE PATIENT'S LEFT TIBIA, APPROXIMATELY THE SIZE OF QUARTER. A TOPICAL ANTIBIOTIC AND DRESSING WAS PLACED OVER THE AREA, AND A WOUND CARE NURSE WAS CALLED TO MEET THE PATIENT IN PACU FOR FURTHER EVALUATION. THE REPORTED DEFECTIVE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Burn, Thermal

  MAUDE report 7413659 ↗
• InjuryApr 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MEDWATCH IS NOT TO REPORT A DEVICE MALFUNCTION, BUT TO REPORT AN ADVERSE PATIENT EFFECT. THERE WAS NO REPORT OF A DEVICE MALFUNCTION DURING THE PROCEDURE. AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2018: PATIENT RECEIVED A SKIN BURN DURING UNIBLATE CASE AT PROBE/INTRODUCER ENTRY SIGHT. PATIENT WAS TAKEN TO PACU AND A WOUND CARE NURSE WAS CALLED TO ASSESS THE BURN. PER THE TREATING PHYSICIAN, HE FELT IT (THE BURN) WOULD HEAL, BUT THAT THE TISSUE WAS NECROSED AROUND THE ENTRY SIGHT. THE LOCATION OF THE BURN WAS THE SKIN ABOVE THE PATIENT'S LEFT TIBIA, APPROXIMATELY THE SIZE OF QUARTER. A TOPICAL ANTIBIOTIC AND DRESSING WAS PLACED OVER THE AREA, AND A WOUND CARE NURSE WAS CALLED TO MEET THE PATIENT IN PACU FOR FURTHER EVALUATION. THE REPORTED DEFECTIVE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Burn, Thermal

  MAUDE report 7411777 ↗