Cardiohelp-I
Brand(s)
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 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 and 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
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