IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.
Reason for recall: IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling. Distribution: Worldwide distribution - US Nationwide and the countries of AU, CA, DE, FR, IN, MX, TW, and VI. Quantity: 91,914 (65,857 US; 26,075 OUS) Lot/code info: UDI-DI (1) 00813502011081 (2) 00813502011180 (3) 00813502011227 (7) 00813502011531 and 00813502012828 (8) 00813502011388 (9) 00813502012279 and 00813502011876 All product IFUs include the Update ***Added February 2024*** (10) 813502010947 (12) 813502011821 (13) 813502011937 (15) N/A (16) 4260113630242 (17) 813502011777 (18) 813502011265 (19) 4260113630280 (20) 813502011609 (21) 813502012200 (22) 813502011944 (23) 4260113630136 (24) 813502010046 (25) 4260113630174 (26) 813502011197 (27) 813502010053 (28) 813502011630 (29) 813502010466 (30) 813502010473 (31) 813502012453 (32) 813502012767 (33) 813502012873 (34) 813502012873 ***Removed from scope March 15, 2024*** (4) 00813502011029 (5) 00813502011869 (6) 00813502012811 (11) 4260113630273 (14) 813502011951
00813502011081, 00813502011180, 00813502011227, 00813502011531, 00813502012828, 00813502011388, 00813502012279, 00813502011876, 813502010947, 813502011821, 813502011937, 4260113630242, 813502011777, 813502011265, 4260113630280, 813502011609, 813502012200, 813502011944, 4260113630136, 813502010046, 4260113630174, 813502011197, 813502010053, 813502011630, 813502010466, 813502010473, 813502012453, 813502012767, 813502012873, 00813502011029, 00813502011869, 00813502012811, 4260113630273, 813502011951
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.