Health product recall

Cardiohelp-I

Last updated

Summary

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

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected Products

Lot or serial number

Model or catalog number

Cardiohelp-I

More than 10 numbers, contact manufacturer.

70104.8012

Issue

It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual force. Insufficient securement of the slide rails to the lateral aspects to Cardiohelp could provide an opportunity of both/either the transport guard and/or the emergency drive (with the holder) to detach from Cardiohelp.  This issue is serial # specific.

Recall Start Date: August 29, 2023 

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Companies

Maquet Cardiopulmonary Gmbh

Kehler Strasse 31, Rastatt, Germany, 76437

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74247

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