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Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS)

Official notice

23 Sept 2026

Last checked

29 Sept 2026

MediumFDA

An official FDA notice concerns Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS). The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2026-09-23. Lots: 3000324477, 3000324479. Recall numbers: Z-3144-2026. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

68,371

Recall number

Z-3144-2026

Official notice

2026-09-23

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.

Lots

3000324477, 3000324479

Other

UDI-DI 4037691519883, UDI-DI 4037691730660

Event Ids

99668

Recall Numbers

Z-3144-2026

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Affected products

Product 1

Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS)

Units affected

68,371

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

AT · Austria

Affected area 4

AU · Australia

Affected area 5

BE · Belgium

Affected area 6

BR · Brazil

Affected area 7

CA · Canada

Affected area 8

CH · Switzerland

Affected area 9

CN · China

Affected area 10

CO · Colombia

Affected area 11

CZ · Czech Republic

Affected area 12

DE · Germany

Affected area 13

DK · Denmark

Affected area 14

ES · Spain

Affected area 15

FI · Finland

Affected area 16

FR · France

Affected area 17

GB · United Kingdom

Affected area 18

HK · Hong Kong

Affected area 19

IE · Ireland

Affected area 20

IN · India

Affected area 21

IT · Italy

Affected area 22

JP · Japan

Affected area 23

KR · South Korea

Affected area 24

MX · Mexico

Affected area 25

NL · Netherlands

Affected area 26

NO · Norway

Affected area 27

NZ · New Zealand

Affected area 28

PL · Poland

Affected area 29

PT · Portugal

Affected area 30

SE · Sweden

Affected area 31

SG · Singapore

Affected area 32

TH · Thailand

Affected area 33

TR · Turkey

Affected area 34

TW · Taiwan

Affected area 35

ZA · South Africa

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Maquet Cardiopulmonary. Contact: Maquet Cardiopulmonary Gmbh.

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-3144-2026

Event id

99668

Units affected

68,371

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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