Health product recall

Cardiohelp-I

Last updated

Summary

Product
Cardiohelp-I
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Cardiohelp-I More than 10 numbers, contact manufacturer. 70104.8012

Issue

During a complaint investigation it was reported that the rotation of the Cardiohelp Emergency Drive hand crank was blocked or impaired. In course of internal investigations, it was found that the safety washer causes this issue. The safety washer was originally introduced to the Cardiohelp Emergency Drive in order to lengthen the shaft of the emergency drive by the thickness of the safety washer reducing the axial pressure on the circlip, safety washer and bearing. (serial # specific)

Recall start date: October 5, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology & Urology
Companies
Maquet Cardiopulmonary Gmbh
Kehler Strasse 31, Rastatt, Germany, 76437
Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-74416