Health product recall

Amplatzer TorqVue Low Profile Delivery System (2021-03-08)

Starting date:
March 8, 2021
Posting date:
March 25, 2021
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-75205

Last updated: 2021-03-25

Affected Products 

Amplatzer TorqVue Low Profile Delivery System

Reason

Abbott initiated a medical device retrieval of impacted sheaths from Batch: 7406296 due to a discrepancy that was observed between the length of the sheath and what was stated on the original packaging. It measured 60cm instead of the anticipated 80cm.

Affected products

Amplatzer TorqVue Low Profile Delivery System

Lot or serial number

Lot 7406296

Model or catalog number

9-TVLP4F90/080

Companies
Manufacturer
ABBOTT MEDICAL
5050 NATHAN LANE NORTH
PLYMOUTH
55442
Minnesota
UNITED STATES