—#157559

Product

Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

FDA product code: DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K943934
Affected lot / code info: Model No. NA-1116, NA-1118, NA-1126, NA-1136, NA-1206, NA-1207, NA-1208, NA-1316, NA-1327, NA-1337, NA-1338, RA-1117, RA-1126, RA-1127, RA-1128A, RA-1136, RA-1137A, RA-1137, RA-1138, RA-1206; Lot No. 1407000078 to 1705200165, S140979 to S141841.

Why it was recalled

Identification of excess plastic on the tip of the cannula.

Root cause (FDA determination)

Process control

Action the firm took

LivaNova sent an Urgent Medical Device letter dated June 16, 2017 to affected customers via certified mail or e-mail. The letter identified the affected product, problem and actions to be taken. The notice instructs customers to remove all recalled product from inventory and contact LivaNova Customer Support at 800-650-2623 to arrange for product return and replacement.

Recalling firm

Firm: Sorin Group USA, Inc.
Address: 14401 W 65th Way, Arvada, Colorado 80004-3503

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide in the states of : AR, AZ, CA, GA, IL, IN, KS, MI, MN, MO, NC, NE, NY, OK, PA, SD, TX, & VA. and foreign countries of: Canada, Iran, Mexico, & New Zealand.

Timeline

Recall initiated: 2017-06-09
Terminated: 2023-11-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #157559. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.