NUERA TIGHT APMD145-1ch.USRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08052049500111), received between May 23, 2022 and Apr 16, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Unclear Information” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K151296); 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem; Unclear Information

  BIOS RECEIVED FROM THE DISTRIBUTOR (B)(4) AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY FOLLOWING TREATMENT BY NUERA DEVICE.

  Patient problems: Burn(s)

  MAUDE report 24896458 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem; Unclear Information

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY FOLLOWING TREATMENT BY NUERA DEVICE.

  Patient problems: Burn(s)

  MAUDE report 24882742 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BIOS RECEIVED FROM LUMENIS (THE IMPORTER) THE NOTIFICATION ON AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED BLISTER USING REUSABLE RETURN PLATE FOLLOWING TREATMENT BY NUERA DEVICE. ACCORDING TO THE PATIENT, THE REUSABLE GROUNDING PAD FELT HOT DURING THE TREATMENT.

  Patient problems: Blister

  MAUDE report 22892963 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED BLISTER USING REUSABLE RETURN PLATE FOLLOWING TREATMENT BY NUERA DEVICE. ACCORDING TO THE PATIENT, THE REUSABLE GROUNDING PAD FEL HOT DURING THE TREATMENT.

  Patient problems: Blister

  MAUDE report 22792969 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY FOLLOWING TREATMENT BY NUERA 1.2 DEVICE.

  Patient problems: Burn(s)

  MAUDE report 16544279 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED BURN FOLLOWING TREATMENT BY NUERA 1.2 DEVICE. CUSTOMER REPORTED WHEN USED 70MM PAD, THE CUSTOMER GOT BURN DURING TREATMENT, TEMPERATURE IS THE SYSTEM IS TOO LOW 37 DEGREES CELSIUS.

  Patient problems: Burn(s)

  MAUDE report 14468786 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151296. One submission often covers many models, so check the product and lot details in each record.

• Z-0052-2018 · Jul 13, 2017 · Terminated
  THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions.