Datascope Introducer Dilator In Iab Insertion Kits

Datascope Introducer Dilator in IAB Insertion Kits Recall Datascope Introducer Dilator devices included in IAB Insertion Kits are being recalled across Canada due to a performance issue. These kits are used in medical procedures involving intra-aortic balloon insertion. The recall is classified as Class I, the most serious type, indicating the product could cause serious adverse health effects or death.

Product
Datascope Introducer Dilator in IAB Insertion Kits
Reason
Performance
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2023-07-12
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/e82aa3b0-54ae-4d3e-8e05-eafd82a17970