Valleylab E7506Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884524000985), received between Aug 15, 2017 and Mar 9, 2021 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Flare or Flash” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PAD CAUSED BURN TO THE PATIENT.

  Patient problems: Burn(s)

  MAUDE report 11444514 ↗
• MalfunctionFeb 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE ABLATION OF PERMANENT ATRIAL FIBRILLATION PROCEDURE, WHILE USING A RETURN ELECTRODE WITH A NON MEDTRONIC GENERATOR, THERE WAS A SECOND-DEGREE BURN AT THE BOTTOM OF THE PATIENT'S BACK- AT THE LUMBAR LEVEL (REDNESS AND PIERCED PHLYCTENA), ABOUT 10 CM HIGH AND 5 CM LARGE. A BIAFINE BANDAGE WAS APPLIED TO THE BURN AND ON THE SECOND DAY THE DEPITHELIZATION PLATE WAS STABLE, THE BANDAGE TULLE GRAS ("OILY TULLE") WAS APPLIED ON THE BURN.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 11271560 ↗
• MalfunctionMay 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT'S OUTPUT WAS TOO HIGH. THE VETERINARIAN WAS BURNT. THE PHOTO SHOWED THAT THE BURN WAS FROM THE PAD AND IN THE ANIMAL NOT IN THE VETERINARIAN.

  Patient problems: Burn(s)

  MAUDE report 10060186 ↗
• InjuryDec 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PATIENT HAD A BURN FROM THE DEVICE. THE EVENT LEAD TO PATIENT'S EXTENDED HOSPITALIZATION FOR 1 DAY.

  Patient problems: Burn(s); No Code Available

  MAUDE report 9412987 ↗
• MalfunctionMar 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, A PATIENT SUSTAINED A WOUND BENEATH THE PATCH IDENTIFIED CONGRUENT WITH A THERMAL INJURY. THE PATIENT IS HEALING FINE AT THIS TIME WITHOUT ADDITIONAL INTERVENTION.

  Patient problems: Burn, Thermal

  MAUDE report 8411889 ↗
• InjuryOct 30, 2018Adverse Event Without Identified Device or Use Problem; Premature Separation; Adverse Event Without Identified Device or Use Problem; Premature Separation

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE WAS NOT ADHERING ENOUGH. THE PATIENT HAD A BURN AND EXTEND THE HOSPITALIZATION FOR 48 HOURS. THEY APPLIED A FLAMAZINE DRESSING TO THE PATIENT.

  Patient problems: Burn(s); No Code Available

  MAUDE report 8019416 ↗
• MalfunctionAug 13, 2018Flare or Flash; Flare or Flash

  ACCORDING TO THE REPORTER, POST PROCEDURE OF ATRIAL FIBRILLATION ABLATION WITHIN THE LAST THREE MONTHS, THERE WERE TWO PATIENTS THAT EXPERIENCED GROUNDING PAD BURNS. THE RETURN PATCH WAS PLACED 1 INCH RIGHT OF THE SPINE AT THE APEX OF SCAPULA.

  Patient problems: Burn(s)

  MAUDE report 7777126 ↗
• MalfunctionAug 9, 2018Flare or Flash; Flare or Flash

  ACCORDING TO THE REPORTER, POST PROCEDURE OF ATRIAL FIBRILLATION ABLATION WITHIN THE LAST THREE MONTHS, THERE WERE TWO PATIENTS THAT EXPERIENCED GROUNDING PAD BURNS. THE RETURN PATCH WAS PLACED 1 INCH RIGHT OF THE SPINE AT THE APEX OF SCAPULA.

  Patient problems: Burn(s)

  MAUDE report 7769504 ↗
• MalfunctionAug 9, 2018Thermal Decomposition of Device; Difficult to Remove; Patient-Device Incompatibility; Difficult to Remove; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, AFTER AN ATRIAL FIBRILLATION ABLATION, A PATIENT FOUND TO HAVE GROUNDING PAD SITE BURN. IT WAS NOTED THAT THE INTEGRATED PRECISION LAB DID NOT USE A FLUOROSCOPY. ALSO NOTED THAT THE CUSTOMER WAS USING A FLEXIBILITY CATHETER, 3.5 MM IRRIGATED TIP. THE RETURNED PATCH WAS PLACED 1 INCH RIGHT OF THE SPINE AT THE APEX OF SCAPULA.

  Patient problems: Burn(s); No Known Impact Or Consequence To Patient; Partial thickness (Second Degree) Burn

  MAUDE report 7767895 ↗
• MalfunctionAug 3, 2018Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD A CRYOBALLOON PULMONARY VEIN ISOLATION AND ALSO HAD A CAVO-TRICUSPID ISTHMUS LINE DONE BY RADIOFREQUENCY ABLATION. BUT DURING FOLLOWUP FOR CARDIOVERSION, IT WAS NOTED THAT THERE APPEARED TO BE A BURN ON THE LEFT LATERAL UPPER THIGH THAT CORRESPONDED TO THE PLACEMENT OF THE RF (RADIO FREQUENCY) DISPERSIVE ELECTRODE UTILIZED. THE PATIENT HAD NOT REPORTED THIS TO THE PHYSICIAN PRIOR. THE RFA (RADIO FREQUENCY ABLATION) PORTION OF THE ABLATION PROCEDURE WAS PERFORMED USING AMPERE, COOLPOINT, AND PRECISION UTILIZING THE AUTOMARK FEATURE. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Burn(s); Burn, Thermal

  MAUDE report 7746792 ↗
• MalfunctionOct 30, 2017Flare or Flash; Flare or Flash

  THE CUSTOMER REPORTED THAT POST PROCEDURE, THE PATIENT EXPERIENCED A SKIN BURN WHERE ONE OF THE TWO GROUNDING PADS HAD BEEN PLACED DURING THE PROCEDURE. TOPICAL TREATMENT WAS APPLIED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Burn(s)

  MAUDE report 6988499 ↗
• InjuryOct 23, 2017Flare or Flash; Flare or Flash

  THE CUSTOMER REPORTED THAT A PATIENT BURN OCCURRED DURING AN ABLATION PROCEDURE WHERE THIS DEVICE WAS USED. THE PROCEDURE WAS PERFORMED TO TREAT A 4.5CM KIDNEY TUMOR, AND INVOLVED A 3.5CM LEVEEN AS WELL AS A BOSTON SCIENTIFIC RF3000 GENERATOR, S/N (B)(4). THE GENERATOR WAS USED FOR 4X15 MINUTES AT 180 WATTS, AND THE NEEDLE WAS REPOSITIONED SEVERAL TIMES. WHEN FOUR ELECTRODES WERE REMOVED, A 2B TO 3RD DEGREE BURN WAS FOUND UNDER A PAD ON THE THIGH. THE BURN WAS 2CMX10CM. THE PATIENT HAD BEEN SWEATING DURING THE ABLATION. THE PATIENT WAS TRANSFERRED FOR TREATMENT OF THE BURNS, INCLUDING SURGERY AS WELL AS "ABRADEMENT" OF NECROTIC TISSUE. AT THE TIME OF THIS REPORT, THE PATIENT WAS STILL RECEIVING TREATMENT WITHIN THE HOSPITAL.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 6969181 ↗
• MalfunctionAug 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT AFTER A PROCEDURE WHERE THIS DEVICE WAS USED, THE PATIENT DEVELOPED BLISTER-LIKE AREAS ON THE RIGHT LOWER FLANK.

  Patient problems: Injury

  MAUDE report 6795142 ↗