FDAFDA · Alimentos y medicamentos·N.º oficial Z-1074-2024
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (4) Product Code 004334 - Impella RP (5) Product Code 0046-0035 - Impella RP with SmartAssist (6) Product Code 1000323 - RP Flex with SmartAssist (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist (8) Product Code 0048-0032 - Impella CP (9) Product Codes 100080 and 0048-0045 - Impella CP with SmartAssist -- ***Added 2/20/24*** (10) 4413 and 004413 - Impella 2.5 Set (11) 5040 and 005040 - Impella 2.5 IMC Pump Set EU (12) 5060 and 005060 - Impella 5.0 IMC Pump Set EU (13) 5064 and 005064 - Impella 5.0 IMC Pump Set Canada (14) 1000115 - Impella CP Pump set, APAC (15) 1000211 - Impella 5.5 Smart Assist Set, JP (16) 1000302 - Impella CP with SmartAssist APAC (17) 1000361 - Impella 5.5 Set AU (18) 1000402 - Impella CP Smart Assist Set (19) 0046-0011 - Impella RP Pump Set, EU (20) 0046-0026 - Impella 5.0 Pump Set ROW (21) 0046-0037 - Impella 5.0 Pump Set APAC (22) 0046-0039 - Impella RP Set APAC (23) 004690-AU - Impella 5.0 Pump Set AU (24) 0048-0002 - Impella CP Pump Set, EU (25) 0048-0002-BR - Impella CP Pump Set BR (26) 0048-0004 - Impella CP Pump Set, Canada (27) 0048-0014 - Impella Smart Assist Set, EU (28) 0048-0024-JP - Impella CP Smart Assist Set, JP (29) 0048-0044 - Impella CP Smart Assist Set, Canada (30) 0048-0047- Impella CP Smart Assist Set APAC (31) 005048-JP - Impella 2.5 Pump Set, Japan (32) 005066-JP - Impella 5.0 Pump Set, Japan (33) 0550-0002 - Impella 5.5 with SmartAssist Set, EU (34) 0550-0004 - Impella 5.5 with SmartAssist Set, CA
Publicado el 21 de febrero de 2024 · Inicio del retiro: 27 de diciembre de 2023
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Abiomed, Inc.
- Distribuidor
- Worldwide distribution - US Nationwide and the countries of AU, CA, DE, FR, IN, MX, TW, and VI.
- Lote
- 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
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.