Abiomed, Inc. recalls
32 recalls.
- Impella Connect Optical AIC recall (Abiomed, Inc.)
Medical deviceClass IReported November 4, 2026 · Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that... - Impella Optical Controller recall (Abiomed, Inc.)
Medical deviceClass IReported November 4, 2026 · Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that... - Automated Impella Controller recall (Abiomed, Inc.)
Medical deviceClass IReported November 4, 2026 · Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that... - Impella Optical Controller recall (Abiomed, Inc.)
Medical deviceClass IReported September 23, 2026 · The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly. - Impella Optical Controller with the below product descriptions and corresponding... recall (Abiomed, Inc.)
Medical deviceClass IReported September 23, 2026 · The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly. - Automated Impella Controller recall (Abiomed, Inc.)
Medical deviceClass IReported September 23, 2026 · The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly. - ABIOMED Intro Kit recall (Abiomed, Inc.)
Medical deviceClass IReported July 22, 2026 · A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing... - ABIOMED Insertion Kit recall (Abiomed, Inc.)
Medical deviceClass IReported July 22, 2026 · A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing... - ABIOMED Impella CP Set recall (Abiomed, Inc.)
Medical deviceClass IReported July 22, 2026 · A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing... - ABIOMED Impella CP Smart Assist Set recall (Abiomed, Inc.)
Medical deviceClass IReported July 22, 2026 · A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing... - ABIOMED Impella CP Set recall (Abiomed, Inc.)
Medical deviceClass IReported July 22, 2026 · A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing... - ABIOMED Impella 5.5 SmartAssist S2 Set recall (Abiomed, Inc.)
Medical deviceClass IReported July 22, 2026 · A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing... - ABIOMED Impella 5.5 Smart Assist Set recall (Abiomed, Inc.)
Medical deviceClass IReported July 22, 2026 · A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing... - ABIOMED Impella CP Introducer Kit 14 Fr recall (Abiomed, Inc.)
Medical deviceClass IReported July 22, 2026 · A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing... - ABIOMED Impella CP Introducer Kit 14 Fr recall (Abiomed, Inc.)
Medical deviceClass IReported July 22, 2026 · A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing... - ABIOMED Introducer Kit 23 Fr recall (Abiomed, Inc.)
Medical deviceClass IReported July 22, 2026 · A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing... - ABIOMED Impella CP Introducer Kit 14 Fr recall (Abiomed, Inc.)
Medical deviceClass IReported July 22, 2026 · A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing... - ABIOMED Impella CP Set recall (Abiomed, Inc.)
Medical deviceClass IReported July 22, 2026 · A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing... - ABIOMED Impella RP Flex with SmartAssist Set recall (Abiomed, Inc.)
Medical deviceClass IReported July 22, 2026 · A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing... - Abiomed Impella CP Set with SmartAssist recall (Abiomed, Inc.)
Medical deviceClass IReported July 1, 2026 · Potential for thrombus formation during prolonged use of the introducer. - Abiomed Impella CP Set with SmartAssist recall (Abiomed, Inc.)
Medical deviceClass IReported July 1, 2026 · Potential for thrombus formation during prolonged use of the introducer. - Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product... recall (Abiomed, Inc.)
Medical deviceClass IReported July 1, 2026 · Potential for thrombus formation during prolonged use of the introducer. - Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product... recall (Abiomed, Inc.)
Medical deviceClass IReported July 1, 2026 · Potential for thrombus formation during prolonged use of the introducer. - Impella CP Set with SmartAssist. Product Codes: 1000080 recall (Abiomed, Inc.)
Medical deviceClass IReported June 24, 2026 · Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical... - Automated Impella Controller recall (Abiomed, Inc.)
Medical deviceClass IReported June 24, 2026 · Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices. - Automated Impella Controller recall (Abiomed, Inc.)
Medical deviceClass IReported June 3, 2026 · A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates... - Automated Impella Controller recall (Abiomed, Inc.)
Medical deviceClass IReported April 8, 2026 · Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5... - Purge Cassette recall (Abiomed, Inc.)
Medical deviceClass IReported April 8, 2026 · Increased risk of purge leaks with Generation 1 purge cassettes. - Impella RP. Product Code: 0046-0011. recall (Abiomed, Inc.)
Medical deviceClass IReported March 11, 2026 · Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. - Impella RP Flex with SmartAssist. Product Code: 1000323. recall (Abiomed, Inc.)
Medical deviceClass IReported March 11, 2026 · Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. - Impella RP with SmartAssist. Product Code: 0046-0035. recall (Abiomed, Inc.)
Medical deviceClass IReported March 11, 2026 · Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. - Impella 5.5 with SmartAssist¿ S2 recall (Abiomed, Inc.)
Medical deviceClass IIReported January 14, 2026 · Device packaged in incorrect outer box carton.