HeartWare Recalls Ventricular Assist System Kit
Framingham, Mass.-based HeartWare is initiating a Class I recall of its ventricular assist system pump driveline splice kit, according to an FDA notice posted Thursday.
The repair kits failed to work properly when exposed to excessive force, the devicemaker says.
The company sent an urgent medical device correction letter on May 11, asking that all consignees:
- Review the notice and the patient communication contents;
- Identify patients who are on support and have undergone a driveline splice repair;
- Distribute the patient communication to the affected patients in person;
- Continue to reinforce the messages described in the notice with patients who have experienced a splice repair; and
- Complete, sign and return the acknowledge and completion form to HeartWare within 30 days of receipt of the letter.
HeartWare urges consumers to contact the company with questions and concerns. View the recall notice at: http://www.fdanews.com/05-18-15-HeartWareRecall.pdf. — Jason Scott