New warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may result in low flow of the device.
Reason for recall: New warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may result in low flow of the device. Distribution: Worldwide distribution - US Nationwide and the countries of AU, CA, DE, FR, IN, MX, TW, and VI. Quantity: 92515 Lot/code info: UDI-DI (1) 00813502011081 (2) 00813502011180 (3) 00813502011227 (4) 00813502011029 (5) 00813502011869 (6) 00813502012811 (7) 00813502011531 and 00813502012828 (8) 00813502011388 (9) 00813502012279 and 00813502011876 All products are affected by IFU Update ***Added 2/20/24*** (10) 813502010947 (11) 4260113630136 (12) 4260113630174 (13) 813502011197 (14) 813502010473 (15) 813502012453 (16) 813502012767 (17) 813502012927 (18) 813502012873 (19) 4260113630273 (20) 813502011821 (21) 813502011937 (22) 813502011951 (23) N/A (24) 4260113630242 (25) 813502011777 (26) 813502011265 (27) 4260113630280 (28) 813502011609 (29) 813502012200 (30) 813502011944 (31) 813502010046 (32) 813502010053 (33) 813502011630 (34) 813502010466
00813502011081, 00813502011180, 00813502011227, 00813502011029, 00813502011869, 00813502012811, 00813502011531, 00813502012828, 00813502011388, 00813502012279, 00813502011876, 813502010947, 4260113630136, 4260113630174, 813502011197, 813502010473, 813502012453, 813502012767, 813502012927, 813502012873, 4260113630273, 813502011821, 813502011937, 813502011951, 4260113630242, 813502011777, 813502011265, 4260113630280, 813502011609, 813502012200, 813502011944, 813502010046, 813502010053, 813502011630, 813502010466
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.