Device Recall Heartstring II Proximal Seal aortic cutter

HSK-2038, HSK-2043. All lots are affected by this recall.

Cardiovascular Devices

2

No

Product was distributed to 274 consignees. 15 are international distributors. 259 hospitals. The product is fully distributed to the following countries: USA, Belgium, CAnada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Israel, Italy, Lebanon, Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, and Swizerland. 3 VAs received product: 13000 Bruce B Downs Blvd, Tampla, FL, 800 Hospital Dr., columbia, MO, and 921 NE 13th st., Oklahoma City, OK.

Aortic Cutter, single use device consisting of grip, cutter, aortic stops, needle, safety lock and actuation button.