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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91294

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
July 19, 2022
Product types
Device
Classifications
Class III
Statuses
Ongoing
Recalling firm wording
NuVasive Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US

Z-1052-2023
Recall number
Z-1052-2023
Initiated
July 19, 2022
Classification
Class III
Status
Ongoing
Recalling firm
NuVasive Inc
Quantity
7

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to an incorrect security key, customers were unable to connect to remote monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremity procedures.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to an incorrect security key, customers were unable to connect to remote monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremity procedures.

Code information

Part Number: 1881500 UDI Code: 0887517PLS137YJ Serial Numbers: PM00017 SM90018 SM90013 SM90021 PM00007 SM90032 SM90030

Distribution pattern

U.S. Nationwide distribution in the states of CA, FL, NC, OH, and TX.