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