Abiomed, Inc. recalls

All Abiomed, Inc. recalls we track from FDA, CPSC and NHTSA data. Categories: medical devices (37).

37 recalls published between January 22, 2025 and September 30, 2026. Most common issues: software (2). 35 were FDA Class I, the most serious level.

• Automated Impella Controller (AIC) with the below product descriptions and… recall
  FDA September 30, 2026 · Abiomed, Inc. · Class II
• Impella Optical Controller, Automated Impella Controller… recall
  FDA September 23, 2026 · Abiomed, Inc. · Class I
• Impella Optical Controller with the below product descriptions and… recall
  FDA September 23, 2026 · Abiomed, Inc. · Class I
• Automated Impella Controller (AIC) with the below product descriptions and… recall
  FDA September 23, 2026 · Abiomed, Inc. · Class I
• ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP… recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Impella CP Set, Pump Set Code 0048-0044 recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Impella CP Set, Pump Set Code 0048-0014 recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460 recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212 recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039… recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038… recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441… recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm… recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Impella CP Set, Pump Set Code 0048-0003… recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323… recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• Abiomed Impella CP Set with SmartAssist (10th Generation) containing… recall
  FDA July 1, 2026 · Abiomed, Inc. · Class I
• Abiomed Impella CP Set with SmartAssist (10th Generation) containing… recall
  FDA July 1, 2026 · Abiomed, Inc. · Class I
• Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP… recall
  FDA July 1, 2026 · Abiomed, Inc. · Class I
• Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP… recall
  FDA July 1, 2026 · Abiomed, Inc. · Class I
• Impella CP Set with SmartAssist recall
  FDA June 24, 2026 · Abiomed, Inc. · Class I
• Automated Impella Controller (AIC), for use with left heart support blood… recall
  FDA June 24, 2026 · Abiomed, Inc. · Class I
• Automated Impella Controller (AIC) with the below product descriptions and… recall
  FDA June 3, 2026 · Abiomed, Inc. · Class I
• Automated Impella Controller (AIC) recall
  FDA June 3, 2026 · Abiomed, Inc. · Class I
• Automated Impella Controller (AIC), labeled as the following with… recall
  FDA April 8, 2026 · Abiomed, Inc. · Class I
• Purge Cassette, sold within Impella Pump Sets and Individually Packaged recall
  FDA April 8, 2026 · Abiomed, Inc. · Class I
• Impella RP. Product Code: 0046-0011 recall
  FDA March 11, 2026 · Abiomed, Inc. · Class I
• Impella RP Flex with SmartAssist recall
  FDA March 11, 2026 · Abiomed, Inc. · Class I
• Impella RP with SmartAssist recall
  FDA March 11, 2026 · Abiomed, Inc. · Class I
• Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU recall
  FDA January 14, 2026 · Abiomed, Inc. · Class II
• Automated Impella Controller (AIC) labeled as the following with… recall
  FDA October 29, 2025 · Abiomed, Inc. · Class I
• Automated Impella Controller (AIC), used for left heart support blood… recall
  FDA October 15, 2025 · Abiomed, Inc. · Class I
• Automated Impella Controller (AIC) with the below brands and product codes recall
  FDA October 1, 2025 · Abiomed, Inc. · Class I
• Automated Impella Controller (AIC), used in left heart support blood pump… recall
  FDA August 6, 2025 · Abiomed, Inc. · Class I
• Impella RP Flex with SmartAssist recall
  FDA January 22, 2025 · Abiomed, Inc. · Class I
• Impella RP with SmartAssist recall
  FDA January 22, 2025 · Abiomed, Inc. · Class I