Amplatzer Steerable Delivery Sheath

AMPLATZER STEERABLE DELIVERY SHEATH Recall The AMPLATZER STEERABLE DELIVERY SHEATH is being recalled across Canada due to labelling and packaging issues. This is a Class I recall, which is the most serious classification. The product is used as a medical device in cardiac procedures.

Product
AMPLATZER STEERABLE DELIVERY SHEATH
Reason
Labelling and packaging
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2021-11-19
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/da0f496a-6f1f-479c-8a39-ca8147f47ae4