 |
| The VenaSeal System--Courtesy of Covidien |
Medtronic's ($MDT) Covidien was hit with a recall of 1,661 units of its VenaSeal Sapheon Closure System, a procedural delivery system for an adhesive that treats venous reflux disease by closing the affected veins in the lower leg.
The device, manufactured in Mansfield, MA, was recalled in April because of a possible breach of the outer packaging material, which may "compromise the outside surface sterility of the sealed inner tray," the FDA says in its recall notice.
In addition to the adhesive, the VenaSeal consists of a dispenser gun and associated catheter, guidewire, dispenser tips, and syringes.
It's now under a Class II recall, reserved for situations in which "use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote," the FDA says.
Affected customers were contacted by letter or email on April 28. The notice does not say what instructions they were given. The recalled devices are spread throughout the world, but there are no customer accounts in the U.S., where a launch is forthcoming following the device's approval in February.
Indeed, the VenaSeal was approved via FDA's stringent PMA pathway for innovative or high-risk (and hence more profitable) devices. In the approval letter, the FDA said the device is unique because it enables vein closure procedures without the use of heat or injections, which reduces the risk of nerve injury and other side effects.
Medtronic justified its acquisition of Covidien by saying the move would allow it to move into additional therapeutic areas, like venous reflux disease (also called chronic venous insufficiency). Covidien also markets the Venefit procedure to treat the disease. It uses minimally invasive radiofrequency ablation.
- read the recall notice
- get more about the device from the FDA