AMPLATZER STEERABLE DELIVERY SHEATH
Brand(s)
Last updated
Summary
Product
AMPLATZER STEERABLE DELIVERY SHEATH
Issue
Medical devices - Labelling and packaging
What to do
Contact the manufacturer if you require additional information
Affected products
Affected Products |
Lot or serial number |
Model or catalog number |
|---|---|---|
AMPLATZER STEERABLE DELIVERY SHEATH |
Not applicable |
ASDS-14F-075 |
Issue
|
The Hemostasis valve in the closed position is not fully sealed and additional steps are required to prevent air ingress. Abbott is providing instructions (including update to the product instructions for use [IFU] and additional product-related customer training) to reduce the potential for air ingress. Recall start date: 2021-11-09 |
Additional information
Details
Original published date: 2021-11-24
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
ABBOTT MEDICAL
5050 NATHAN LANE NORTH, PLYMOUTH
MN, UNITED STATES
55442
Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63641