Device product
Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis.
Z-1019-2022
Product summary
- Event
- Event 89897
- Status
- Terminated
- Classification
- Class II
- Quantity
- 300 devices
- Official record key
device-enforcement:Z-1019-2022
Official wording
Reason: There is a potential for foreign matter.
Code information: Product Code: FT12150; Lot: SP21J21-1584173
Distribution pattern: Distribution in the United States including AL, CA, KY, NY, OR, PA, and TX OUS distribution to Japan, Italy, Netherlands, Switzerland, and United Kingdom
Derived failure modes
-
Foreign material or chemical contamination
foreign matter