Abiomed Recalls
A hospital operating room with medical equipment (representative file photo). Specific recalled device: see recall details below. Photo: FDA / Public Domain.
- Recalls in database
- 21
- Agency
- FDA
- Years covered
- 2011–2026
How this hub is built. This page collects 6 recall events tied to Abiomed (across 21 product-line records) in the current 411 Press recall dataset. A note on counting. The three agencies package recalls differently. NHTSA issues one record per safety campaign; the CPSC issues one per recall; the FDA issues one per affected product line, so a single FDA recall can appear as dozens of records. Counting raw records would push FDA-heavy brands artificially to the top. The counts here are recall EVENTS — distinct agency events — with the FDA product-line record total shown alongside wherever the two differ. Records are grouped by a normalized version of the recalling firm's name (normalizer version 2026-07-28.C3.2). Parent, subsidiary, and "doing business as" relationships are not merged unless the agency data states them, so a corporate family can appear under more than one name. Regulator for these records: FDA. They were published 2011–2026. An event count reflects how much recall activity fell inside the current dataset — not a ranking of relative safety. Larger manufacturers and higher-volume product lines generate more recall activity. This is the current dataset, not an all-time total, and it grows as new notices are ingested. Every row links to the original agency notice.
2026 (20)
- Class I
ABIOMED Introducer Kit 23 Fr
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 issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
- Class I
ABIOMED Intro Kit
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 issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
- Class I
ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP
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 issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
- Class I
ABIOMED Impella RP Flex with SmartAssist Set
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 issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
- Class I
ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP
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 issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
- Class I
ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046
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 issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
- Class I
ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046
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 issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
- Class I
ABIOMED Impella CP Set
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 issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
- Class I
ABIOMED Impella CP Introducer Kit 14 Fr
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 issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
- Class I
ABIOMED Impella CP Introducer Kit 14 Fr
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 issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
- Class I
ABIOMED Impella CP Introducer Kit 14 Fr
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 issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
- Class I
ABIOMED Impella 5.5 SmartAssist S2 Set
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 issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
- Class I
ABIOMED Impella 5.5 Smart Assist Set
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 issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
- Class I
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13
Potential for thrombus formation during prolonged use of the introducer.
- Class I
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits
Potential for thrombus formation during prolonged use of the introducer.
- Class I
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP
Potential for thrombus formation during prolonged use of the introducer.
- Class I
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP
Potential for thrombus formation during prolonged use of the introducer.
- Class I
Impella CP Set with SmartAssist
Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.
- Class I
Automated Impella Controller (AIC), for use with left heart support blood pump
Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
- Class I
Automated Impella Controller (AIC); Product Code: 0042-0000-US
A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received service are pending these updates. Issue 1: The proximity of the internal Video Graphics Array cable to the Digital Signal Processor chipset on the Impellatronic printed circuit assembly could potentially result in Electrostatic Discharge coupling into the Digital Signal Processor which may interrupt motor controls. Issue 2: There is a potential for the Compact Flash Memory Card dislodgement due to external applied forces, which could result in AIC startup failures and data logging issues. Issue 3: Improper routing of the fan wire within the AIC could lead to fan wire damage, which may result in console boot-up failure. Issue 4: Potential capacitor related issues on the Power Battery Manager, including the potential for the capacitors to cause pump stop, purge stop, and/or single fan fuse failures.
2011 (1)
- Class I
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes
Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can result in a piston block event and lead to the inability to complete priming of the purge system, requiring the user to switch to backup AIC console.