NA DB-4252Recalls & reported problems

Boston Scientific Neuromodulation Corporation · 28cm Straw Tunneling Tool · Class 3 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729896098), received between May 10, 2024 and May 10, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

4 other recalls cover devices cleared under the same FDA submission (P150031); 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Use of Device Problem1

Patient problems

Perforation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryMay 10, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING THE DEEP BRAIN STIMULATION (DBS) IMPLANT PROCEDURE WHILE TUNNELING THE LEAD EXTENSION WITH THE TUNNELING TOOL THE SURGEON PERFORATED THE SKIN. THE WOUND WAS ADDRESSED AND CLOSED. THE IMPLANT PROCEDURE WAS COMPLETED. THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE TUNNELING TOOL WAS DISPOSED AT THE FACILITY AND WAS NOT RETURNED TO BSC.
Patient problems: Perforation
MAUDE report 19293901 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150031. One submission often covers many models, so check the product and lot details in each record.

Z-2558-2025 · Jul 8, 2025 · Open, Classified
Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
Z-2340-2025 · Jul 8, 2025 · Open, Classified
Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual
Z-1890-2024 · Apr 18, 2024 · Open, Classified
Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320
Z-2125-2020 · Apr 24, 2019 · Terminated
Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Brain Stimulation (DBS) System is indicated for use in bilateral stimulation of the

Device details

UDI-DI	`08714729896098`
Brand	NA
Model	DB-4252
Company	Boston Scientific Neuromodulation Corporation
Product code	NHL · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
Class	Class 3
FDA submission	P150031
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 10, 2026

Device type (GMDN): Deep brain electrical stimulation system

An assembly of sterile implantable devices designed to apply electrical stimuli to specific areas of the deep brain for the treatment of movement disorders (e.g. essential tremor, symptoms of Parkinson’s disease, epilepsy, dystonia), psychiatric disorders (e.g. obsessive-compulsive disorder, depression, anxiety disorder), and/or to treat chronic, severe, intractable pain. It typically consists of leads implanted in the brain, lead extensions, and a pulse generator that is typically implanted near the sternum.

Other STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS devices

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Activa® RC 37612
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NA NM-3138-55
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198 reports

All STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS devices →

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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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