NIM-Pulse® 8253202 (UDI 00643169230415)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169230415), received between Jan 28, 2020 and May 17, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K083124); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DEVICE DOESN'T STIMULATE. NO CONSEQUENCES OR IMPACT TO PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19339153 ↗
• MalfunctionJan 29, 2020Use of Device Problem; Use of Device Problem

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE MAINFRAME WAS DEFECTIVE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9641209 ↗
• MalfunctionJan 28, 2020Use of Device Problem; Use of Device Problem

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT A NERVE MONITORING DEVICE WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9637401 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083124. One submission often covers many models, so check the product and lot details in each record.

• Z-2342-2012 · Sep 27, 2010 · Terminated
  Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Response) LABELING: Box Label: REF 8253200 x1***NIM-Response 3.0 Patient
• Z-2343-2012 · Sep 27, 2010 · Terminated
  Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (Neuro). LABELING: Box Label: REF 8253410 x1***NIM-Response 3.0 Patie
• Z-2344-2012 · Sep 27, 2010 · Terminated
  Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253210 (Pulse). LABELING: Box Label: REF 8253210 x1***NIM-Response 3.0 Patie