Fogarty Catheters (2019-03-27)
- Starting date:
- March 27, 2019
- Posting date:
- May 3, 2019
- 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-69806
Last updated: 2019-05-03
Affected Products
A. Fogarty Catheters
B. Fogarty Balloon Catheter
Reason
Customer complaints were received for these devices with various issues with the balloons. This included inflation, deflation, detachments and bursts.
Affected products
A. Fogarty Catheters
Lot or serial number
All lots, contact manufacturer.
Model or catalog number
830705F
Companies
- Manufacturer
-
Edwards Lifesciences LLC
1 Edwards Way
Irvine
92614
California
UNITED STATES
B. Fogarty Balloon Catheter
Lot or serial number
All lots, contact manufacturer.
Model or catalog number
830515F
Companies
- Manufacturer
-
Edwards Lifesciences LLC
1 Edwards Way
Irvine
92614
California
UNITED STATES