Vermed IP-Set N3-Pediatric-USRecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

5 other recalls cover devices cleared under the same FDA submission (K101685); 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 18, 2026.

Recalls naming this device

1. Mar 15, 2022Class IITerminated

   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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101685. One submission often covers many models, so check the product and lot details in each record.

• Z-0937-2022 · Mar 15, 2022 · Terminated
  CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-US
• Z-0936-2022 · Mar 15, 2022 · Terminated
  CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US
• Z-0939-2022 · Mar 15, 2022 · Terminated
  CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-US
• Z-0940-2022 · Mar 15, 2022 · Terminated
  CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model: 32028781 50604-US
• Z-0938-2022 · Mar 15, 2022 · Terminated
  CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US