PULSE 5050401Recalls & reported problems
Nuvasive, Inc. · PULSE Single Patient Reference Array Kit · Class 2
All models of PULSE (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00195377051004), received between Apr 4, 2022 and Apr 4, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).
1 other recall cover devices cleared under the same FDA submission (K210574); 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
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 4, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A PATIENT UNDERWENT A C1 TO C5 POSTERIOR CERVICAL FUSION CASE FOR WHICH THE TWO SCREWS LOCATED AT C1 AND TWO SCREWS LOCATED AT C2 WERE PLACED USING THE PULSE III SYSTEM NAVIGATION. AFTER SCREW PLACEMENT, IT WAS IDENTIFIED THAT THE TWO SCREWS AT C1 APPEARED 3-4 MM OFF OF THE INTENDED LOCATION IN THE SAGITTAL PLANE. DURING POST-OPERATIVE EVALUATION ON A 3D RADIOGRAPH IT WAS DETERMINED THAT THE SCREWS DID NOT REQUIRE REPOSITIONING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14002297 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K210574. One submission often covers many models, so check the product and lot details in each record.
- Z-1052-2023 · Jul 19, 2022 · Open, ClassifiedNuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
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- Stealthstation® S7™ 9733858Medtronic Navigation, Inc. · Neurological stereotaxic Instrument8 deaths984 reports
- Stealthstation® S7™ 9733858Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 death695 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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