An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Reason for recall: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves. Distribution: Domestic: Nationwide Distribution. International: Canada. Quantity: 1,156 units Lot/code info: Model Number: 190395; UDI/DI: 00840861100958; Serial Number: 6K0S-985P, 7K0S107747, 6K0S-021M, 7K0S103530, 6K0S-780R, 6K0S-192E, 6K0S-217E, 7K0S102986, 7K0S110138, 7K0S110142, 7K0S106422, 4K0S-P981, 4K0S-N154, 4K0S-N157, 4K0S-Q697, 5K0S-V190, 5K0S-V199, 6K0S-012R, 4K0S-M705, 4K0S-M708, 4K0S-N842, 4K0S-N843, 4K0S-N846, 4K0S-N850, 4K0S-N913, 4K0S-P289, 4K0S-P290, 4K0S-P298, 4K0S-P299, 4K0S-R079, 4K0S-R106, 4K0S-R114, 4K0S-R082, 4K0S-R136, 4K0S-S707, 4K0S-S708, 4K0S-S716, 6K0S-320H, 6K0S-325H, 6K0S-332H, 4K0S-S713, 5K0S-309C, 4K0S-M703, 4K0S-N847, 4K0S-R080, 4K0S-L722, 4K0S-N152, 4K0S-N155, 4K0S-N159, 4K0S-P291, 4K0S-P294, 4K0S-P295, 4K0S-Q694, 4K0S-Q688, 4K0S-R107, 4K0S-R081, 5K0S-T891, 4K0S-R135, 7K0S106375, 5K0S-168D, 5K0S-Z661, 5K0S-Z668, 4K0S-S711, 5K0S-306C, 5K0S-159D, 5K0S-881D, 6K0S-491J, 6K0S-501F, 6K0S-435N, 7K0S108256, 6K0S-746N, 5K0S-311C, 6K0S-508F, 6K0S-016M, 5K0S-305C, 6K0S-532F, 6K0S-318H, 6K0S-722R, 5K0S-Y002, 6K0S-481K, 6K0S-488K, 6K0S-669L, 4K0S-Q643, 5K0S-Y003, 4K0S-M704, 4K0S-M707, 4K0S-N849, 4K0S-P288, 4K0S-Q641, 4K0S-Q689, 4K0S-Q690, 4K0S-Q691, 4K0S-R109, 4K0S-R113, 4K0S-R134, 4K0S-R137, 4K0S-S704, 5K0S-T897, 5K0S-T898, 5K0S-V200, 5K0S-V201, 5K0S-X989, 5K0S-883D, 6K0S-468G, 6K0S-847G, 6K0S-848G, 6K0S-092L, 6K0S-322L, 6K0S-673L, 6K0S-992P, 6K0S-998P, 4K0S-M706, 4K0S-R083, 4K0S-S712, 4K0S-S722, 5K0S-V191, 5K0S-V204, 5K0S-X987, 5K0S-X990, 5K0S-Z667, 5K0S-466B, 6K0S-219E, 6K0S-482J, 6K0S-835N, 6K0S-778R, 7K0S100621, 7K0S102665, 7K0S103781, 4K0S-S715, 5K0S-V202
00840861100958
Official record: FDA (Device enforcement) ↗
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