Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code: 0043-0003. 2. Impella RP US Pump Set; Product Code: 004334. 3. Purge Cassette, Packaged; Product Code: 0043-0002. Also included inside Product Code 0043-0003 above. Product Code 0043-0002 also includes innermost packaged product with Product Code 0043-0001. 4. Impella 2.5 Set; Product C

Official notice

Original summary

Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code: 0043-0003. 2. Impella RP US Pump Set; Product Code: 004334. 3. Purge Cassette, Packaged; Product Code: 0043-0002. Also included inside Product Code 0043-0003 above. Product Code 0043-0002 also includes innermost packaged product with Product Code 0043-0001. 4. Impella 2.5 Set; Product Code: 004413 (Customer facing code 005040). 5. Impella RP Pump Set, EU; Product Code: 0046-0011. 6. Impella CP Pump Set, EU; Product Code: 0048-0002. 7. Impella CP Pump Set BR; Product Code: 0048-0002-BR. 8. Impella CP Smart Assist Set, EU; Product Code: 0048-0014 (Also inclusive of codes 0048-0047 and 1000402 listed below). 9. Impella CP Smart Assist Set, Canada; Product Code: 0048-0044. 10. Impella CP Smart Assist Set APAC; Product Code: 0048-0047 (inclusive under code 0048-0014). 11. Impella 5.0 IMC Pump Set EU; Product Code: 005060. 12. Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002. 13. Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004. 14. 5.5 Accessories AU; Product Code: 1000362. 15. Impella CP Smart Assist Set; Product Code: 1000402 (inclusive under code 0048-0014). Increased risk of purge leaks with Generation 1 purge cassettes. 1. Product Code: 0043-0003. GTIN: 00813502011135. All Purge Cassette batches/lot numbers are affected. 2. Product Code: 004334. GTIN: 00813502011029. All Purge Cassette batches/lot numbers are affected. 3. Product Code: 0043-0002. GTIN: 00813502010510. All Purge Cassette batches/lot numbers are affected. Also included inside Product Code 0043-0003 above. Product Code 0043-0002 also includes innermost packaged product with Product Code 0043-0001 (GTIN: 00813502011999). 4. Product Code: 004413 (Customer facing code 005040). GTIN: 00813502010947. All Purge Cassette batches/lot numbers are affected. 5. Product Code: 0046-0011. GTIN: 04260113630273. All Purge Cassette batches/lot numbers are affected. 6. Product Code: 0048-0002. GTIN: 04260113630242. All Purge Cassette batches/lot numbers are affected. 7. Product Code: 0048-0002-BR. GTIN: 00813502011777. All Purge Cassette batches/lot numbers are affected. 8. Product Code: 0048-0014 (Also inclusive of codes 0048-0047 and 1000402 listed below). GTIN: 04260113630280. All Purge Cassette batches/lot numbers are affected. Finished Good Batch Numbers: 2024309080, 2024309083, 2024309085, 2024309088, 2024309091, 2024309095, 2024309099, 2024309104, 2024309109, 2024309112, 2024309333, 2024309335, 2024309339, 2024309343, 2024309346, 2024309347, 2024309349, 2024309350, 2024309351, 2024309355, 2024310812, 2024310813, 2024310815, 2024310817, 2024310818, 2024310819, 2024310823, 2024310824, 2024310825, 2024310826, 2024317648, 2024317649, 2024317650, 2024317651, 2024317652, 2024317653, 2024317654, 2024317655, 2024317657, 2024317660, 2024324585, 2024324587, 2024324588, 2024324589, 2024324591, 2024324592, 2024324593, 2024324594, 2024324595, 2024324596, 2024328613, 2024328619, 2024328620, 2024328622, 2024328625, 2024328629, 2024328634, 2024328636, 2024328640, 2024328641, 2024328666, 2024328670, 2024328675, 2024328692, 2024328706, 2024328716, 2024328718, 2024328720, 2024328722, 2024328723, 2024328737, 2024328741, 2024328743, 2024328749, 2024328752, 2024328755, 2024328760, 2024328762, 2024328764, 2024328767, 2024328778, 2024328780, 2024328782, 2024328785, 2024328788, 2024328790, 2024328792, 2024328795, 2024328798, 2024328801, 2024328878, 2024328879, 2024328880, 2024328881, 2024328892, 2024328893, 2024328894, 2024328896, 2024328897, 2024328898, 2024328912, 2024328913, 2024328914, 2024328915, 2024328917, 2024328919, 2024328920, 2024328922, 2024328923, 2024328924, 2024329278, 2024329279, 2024329281, 2024329477, 2024329492, 2024329497, 2024329504, 2024329506, 2024329508, 2024329511, 2024329513, 2024329517, 2024329521, 2024329540, 2024329577, 2024329581, 2024329595, 2024329600, 2024329610, 2024329616, 2024329623, 2024329640, 2024329645, 2024329688, 2024329689, 2024329690, 2024329695, 2024329697, 2024329698, 2024329701, 2024329702, 2024329704, 2024329709, 2024329816, 2024329820, 2024329821, 2024329827, 2024329829, 2024329838, 2024329840, 2024329843, 2024329846, 2024329849, 2024330386, 2024330389, 2024330391, 2024330395, 2024330396, 2024330420, 2024330422, 2024330423, 2024330425, 2024330427, 2024330753, 2024330754, 2024330755, 2024330756, 2024330757, 2024330758, 2024330759, 2024330760, 2024331236, 2024331237, 2024331240, 2024331241, 2024331242, 2024331243, 2024331245, 2024331247, 2024331248, 2024331249, 2024331262, 2024331263, 2024331264, 2024331265, 2024331266, 2024331268, 2024331270, 2024331271, 2024331276, 2024331277, 2024331282, 2024331293, 2024331294, 2024331296, 2024331297, 2024331299, 2024331303, 2024331305, 2024331309, 2024331312, 2024331314, 2024331318, 2024331319, 2024331322, 202