Health product recall

CardioMEMS Patient Electronics System

Brand(s)
Last updated

Summary

Product
CardioMEMS Patient Electronics System
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

CardioMEMS Patient Electronics System

S/N: V7LSK5

CM1100

Issue

Abbott has received reports of an issue following migration of the merlin.net patient care network hf portal to the cloud environment on September 30, 2024. Since then, certain patients have been impacted, and their patient electronics system may be sending incorrect pressure readings. While the issue is being investigated, Abbott is advising users to pause using these patients' pulmonary artery pressure readings for clinical decision-making or patient management.

Recall start date: October 9, 2024

 

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Abbott Medical
387 Technology Circle  Nw, Atlanta, Georgia, United States, 30313
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76358

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