Food, drugs, devices › NuVasive Inc
Device recall: NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
NuVasive Inc (San Diego, CA) initiated this device recall on 19 Jul 2022; FDA lists 1 product record under event 91294, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. NuVasive Inc has 6 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
NuVasive Inc, San Diego, CA.
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."
Distribution
"U.S. Nationwide distribution in the states of CA, FL, NC, OH, and TX."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1052-2023 | NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US | 7 | Class III | Ongoing | 15 Feb 2023 |
Context
Other enforcement events for NuVasive Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 10 Nov 2022 | X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation. | Device | Class II | 1 |
| 20 Jun 2022 | Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6; Simplify Disc Size 2, Ht 4/MD-4; Sim | Device | Class II | 1 |
| 10 Jun 2020 | Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for | Device | Class II | 1 |
| 13 Feb 2020 | NUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product Usage: comprised of a sterile single-use spin | Device | Class II | 1 |
| 5 Jan 2009 | Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI | Device | Class II | 31 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "U.S. Nationwide distribution in the states of CA, FL, NC, OH, and TX."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.