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Boston Scientific Neuromodulation Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09 - safety alert

Official notice

24 Sept 2025

MediumFDA

An official FDA notice concerns Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2025-09-24. Recall numbers: Z-2558-2025. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

25,260

Recall number

Z-2558-2025

Official notice

2025-09-24

The hazard

Health risk requiring medical assessment

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Other

UDI-DI 08714729985044

Event Ids

97144

Recall Numbers

Z-2558-2025

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Affected products

Product 1

Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09

Units affected

25,260

Risk / hazard

Health risk requiring medical assessment

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

US · United States

Affected area 1

US · United States

Affected area 2

AE · United Arab Emirates

Affected area 3

AR · Argentina

Affected area 4

AT · Austria

Affected area 5

BE · Belgium

Affected area 6

BG · Bulgaria

Affected area 7

BR · Brazil

Affected area 8

CA · Canada

Affected area 9

CH · Switzerland

Affected area 10

CL · Chile

Affected area 11

CN · China

Affected area 12

CO · Colombia

Affected area 13

DE · Germany

Affected area 14

DK · Denmark

Affected area 15

EG · Egypt

Affected area 16

ES · Spain

Affected area 17

FI · Finland

Affected area 18

FR · France

Affected area 19

GB · United Kingdom

Affected area 20

GR · Greece

Affected area 21

HK · Hong Kong

Affected area 22

HR · Croatia

Affected area 23

HU · Hungary

Affected area 24

IE · Ireland

Affected area 25

IL · Israel

Affected area 26

IN · India

Affected area 27

IS · Iceland

Affected area 28

IT · Italy

Affected area 29

JO · Jordan

Affected area 30

JP · Japan

Affected area 31

KR · South Korea

Affected area 32

KW · Kuwait

Affected area 33

LU · Luxembourg

Affected area 34

MT · Malta

Affected area 35

MX · Mexico

Affected area 36

NL · Netherlands

Affected area 37

NO · Norway

Affected area 38

PK · Pakistan

Affected area 39

PL · Poland

Affected area 40

PT · Portugal

Affected area 41

RO · Romania

Affected area 42

RS · Serbia

Affected area 43

SA · Saudi Arabia

Affected area 44

SE · Sweden

Affected area 45

SG · Singapore

Affected area 46

SK · Slovakia

Affected area 47

TH · Thailand

Affected area 48

TW · Taiwan

Affected area 49

UA · Ukraine

Affected area 50

ZA · South Africa

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Boston Scientific Neuromodulation. Contact: Boston Scientific Neuromodulation Corporation.

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-2558-2025

Event id

97144

Units affected

25,260

Status

active

Classification

Class II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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