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Bionic Navigator ™ DB-7101-204

by Boston Scientific Neuromodulation

Bionic Navigator ™ DB-7101-204 is a Class III device made by Boston Scientific Neuromodulation, approved under FDA PMA P150031 on 8 Dec 2017 and listed in FDA GUDID since 15 Dec 2017 (UDI-DI 08714729972518), active as of 23 Oct 2026. 4 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

PMA P150031

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08714729972518 UDI-DI Date15 Dec 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP150031 Date8 Dec 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P150031 decided 8 Dec 2017 Active
  • FDA GUDID UDI-DI 08714729972518 listed 15 Dec 2017 Listed

Recalls

4 recalls · 3 ongoing · FDA

    • Ongoing Z-2558-2025 FDA Class II initiated 8 Jul 2025

    Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful stimulation, thus requiring device removal/replacement and users may experience high monopolar impedances, undesired sensation, loss of therapy, return of symptoms and/or Bluetooth connectivity challenges.

    • Ongoing Z-2340-2025 FDA Class II initiated 8 Jul 2025

    Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) system, which may lead to procedural delay, or lead-migration-which may require additional surgery.

    • Ongoing Z-1890-2024 FDA Class II initiated 18 Apr 2024

    Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead transient loss of stimulation; patients may experience undesired sensations, transient worsening of movement disorder symptoms, which may lead patient to request surgical intervention for replacement or revision.

    • Terminated Z-2125-2020 FDA Class II initiated 24 Apr 2019

    The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.

Timeline

6 dated events

  1. Approved FDA PMA P150031
  2. Listed FDA GUDID 08714729972518
  3. Recall initiated FDA recalls Z-2125-2020
  4. Recall initiated FDA recalls Z-1890-2024
  5. Recall initiated FDA recalls Z-2558-2025
  6. Recall initiated FDA recalls Z-2340-2025

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

GUDID

Trade name
Bionic Navigator ™
Generic name
Deep brain electrical stimulation system
Model / reference
DB-7101-204
Primary DI / UDI-DI
08714729972518
PMA number
FDA product code
NHL
GMDN term
Deep brain electrical stimulation system
Device class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Category: Deep brain electrical stimulation system

Cleared under the same submission (P150031)

and 8 more cleared under P150031

Similar devices

Other devices filed under FDA product code NHL (STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS).

Other devices from Boston Scientific Neuromodulation

See all devices from Boston Scientific Neuromodulation →

Properties

  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)