VermedRecalls & reported problems across all models

We found 8 models of Vermed by Graphic Controls Acquisition Corp in the FDA's device registry (GUDID). Together they are named in 133 adverse event reports in the FDA's MAUDE database, received between May 25, 2018 and Sep 24, 2026 — classified as 133 injuries.

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

6 FDA recall records name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Vermed recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 15, 2022Terminated

   Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.

   Z-0940-2022 · Root cause: Device Design · Recall details · FDA record ↗

2. Mar 15, 2022Terminated

   Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.

   Z-0939-2022 · Root cause: Device Design · Recall details · FDA record ↗

3. Mar 15, 2022Terminated

   Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.

   Z-0938-2022 · Root cause: Device Design · Recall details · FDA record ↗

4. Mar 15, 2022Terminated

   Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.

   Z-0937-2022 · Root cause: Device Design · Recall details · FDA record ↗

5. Mar 15, 2022Terminated

   Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.

   Z-0936-2022 · Root cause: Device Design · Recall details · FDA record ↗

6. Mar 15, 2022Terminated

   Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.

   Z-0935-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported Vermed problems

Vermed models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Vermed A10091-30

  Electrode, Electrocardiograph
  132 reports
• Vermed IP-Set 5V RT Adult-US

  Electrode, Electrocardiograph
  1 recall0 reports
• Vermed IP-Set 6V RT ADULT-US

  Electrode, Electrocardiograph
  1 recall0 reports
• Vermed IP-Set 12 RT Adult-US

  Electrode, Electrocardiograph
  1 recall0 reports
• Vermed IP-Set M5 RT Adult-US

  Electrode, Electrocardiograph
  1 recall0 reports
• Vermed IP-Set M3 RT Adult-US

  Electrode, Electrocardiograph
  1 recall0 reports
• Vermed IP-Set N3-Pediatric-US

  Electrode, Electrocardiograph
  1 recall0 reports
• Vermed A10091-5

  Electrode, Electrocardiograph
  1 report

Recent Vermed adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient reported skin irritation in the form of rash and hives. The patient sought medical treatment and was treated with a prescription oral antihistamine. The patient reported following proper skin preparation steps.

  Patient problems: Rash; Skin Inflammation/ Irritation

  MAUDE report 50881822 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  The patient reported experiencing skin irritation in the form of general redness, irritation, and itching. Medical treatment was sought and the patient was treated with a prescription topical anti-inflammatory medication. The patient reported following the recommended skin preparation steps.

  Patient problems: Erythema; Skin Inflammation/ Irritation

  MAUDE report 50794845 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  The patient reported experiencing skin irritation in the form of a rash and open sores, describing the skin as looking "burnt" and becoming raw and aggravated. Medical treatment was sought and the patient was prescribed both oral and topical steroids. The patient reported following the recommended skin preparation steps.

  Patient problems: Rash; Skin Inflammation/ Irritation

  MAUDE report 50794733 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  The patient reported experiencing skin irritation in the form of a rash, bleeding/discharge, and rawness with open skin. Medical treatment was sought and the patient was prescribed both oral and topical steroids. The patient reported following the recommended skin preparation steps.

  Patient problems: Rash; Skin Inflammation/ Irritation

  MAUDE report 50794589 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  The patient reported experiencing skin irritation in the form of general redness, raised skin, blisters/welts, and scabbing. Medical treatment was sought and the patient was treated with a prescription topical steroid. The patient reported following the recommended skin preparation steps.

  Patient problems: Blister; Erythema; Skin Inflammation/ Irritation

  MAUDE report 50794149 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  The patient reported a burning sensation and hives. The patient sought medical treatment and was prescribed a topical anti-inflammatory medication. The patient confirmed following the proper skin preparation steps.

  Patient problems: Burning Sensation

  MAUDE report 50732942 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  The patient reported skin irritation in the form of an allergic reaction of unknown type. The patient sought medical treatment and was prescribed medication. The patient did not follow proper skin preparation steps.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 50732936 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient reported skin irritation in the form of hives. The patient sought medical treatment and was prescribed triamcinolone, an oral steroid. The patient reported following the proper skin preparation steps.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 50732933 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  The patient reported skin irritation in the form of itching and open sores. The patient sought medical treatment and was treated with prescription medication (topical steroid). The patient reported following the proper skin preparation steps.

  Patient problems: Itching Sensation; Skin Inflammation/ Irritation

  MAUDE report 50732929 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  Patient reported skin irritation in the form of general redness, irritation, and red bumps with no open skin. The patient sought medical treatment and was treated with a prescription topical anti-inflammatory medication. The patient followed the recommended skin preparation steps.

  Patient problems: Erythema; Skin Inflammation/ Irritation

  MAUDE report 50619223 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  The patient reported experiencing a rash. Medical treatment was sought and the patient was treated with a prescription topical steroid. The patient reported following the recommended skin preparation steps.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 50618549 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Erythema; Itching Sensation; Skin Inflammation/ Irritation

  MAUDE report 50618168 ↗
• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  The patient reported skin irritation in the form of itching. Patient sought medical treatment and was perscribed Mometasone Furoate 0.01%, a topical anti-inflammatory medication. The patient followed the recommended skin preparation steps.

  Patient problems: Itching Sensation; Skin Inflammation/ Irritation

  MAUDE report 50452734 ↗
• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  The patient reported experiencing burning sensations, general redness, itching, and blisters/welts. Medical treatment was sought and the patient was treated with a prescription topical anti-inflammatory medication. The patient reported following the recommended skin preparation steps.

  Patient problems: Blister; Erythema; Skin Burning Sensation; Skin Inflammation/ Irritation

  MAUDE report 50439809 ↗
• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  The patient reported skin irritation in the form of hives. The patient sought medical attention and was prescribed a medication. The patient followed the proper skin preparation guidelines.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 50344024 ↗