Health product recall

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 product - Medical device - 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