Indeflator Device
Brand(s)
Last updated
Summary
Product
Indeflator Device
Issue
Medical devices - Quality
What to do
Contact the manufacturer if you require additional information.
Affected products
| Affected Products | Lot or Serial Number | Model or catalog number |
|---|---|---|
| Indeflator Plus 30 Inflation Device | More than 10 numbers, contact manufacturer. | 1000183, 1000185 |
| 20/30 Priority Pack Accessory Kit With Copilot | More than 10 numbers, contact manufacturer. | 1003327 |
| 20/30 Indeflator Inflation Device | More than 10 numbers, contact manufacturer. | 1000184, 1000186, 1000186-115 |
Issue
Devices from these lots may exhibit leaks and/or a loose connection at the rotating luer assembly or stopcock connection, which could lead to air ingress under vacuum. Analysis indicates an estimated rate of occurrence of air ingress associated with the device is 0.4%. While no long-term adverse patient effects have been associated with this issue, potential risks include air embolism, thrombosis and foreign body in patient.
Recall start date: Mar 11, 2022
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Abbott Vascular
3200 Lakeside Drive, Santa Clara, California
United States, 95054-2807
Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-64029
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