Abiomed, Inc.

Abiomed heart pump introducer sheaths in the Intro Kit may leak fluid from under the sheath cap or along the hub score lines. The manufacturing defect is not visible to users. All current batches of the kit worldwide are affected.

Abiomed has recalled the Impella CP heart pump due to a potential for fluid leakage from the introducer sheath (a tube inserted during the procedure). The leakage can occur under the sheath cap or along connection points, and these defects cannot be seen by the user. All current batches of the pump set are affected worldwide.

Abiomed has recalled its Impella CP Smart Assist Set heart pump due to a potential leak in the introducer sheath (a thin tube used during insertion). The leak can occur under the sheath cap or along seam lines in certain models, but the defect is not visible to the user. All current batches worldwide are affected.

Abiomed has recalled the Impella CP heart pump set due to a manufacturing defect in the introducer sheath that can cause leakage. The leakage can occur under the sheath cap or along hub score lines in the 14Fr and 23Fr introducers included with every pump set, and the defect is not visible to users.

Abiomed has recalled certain Impella 5.5 SmartAssist S2 heart pump sets worldwide due to a manufacturing defect in the introducer sheaths. The 14Fr and 23Fr introducers included in these pump sets may leak fluid from under the sheath cap or along hub seams, and the leakage cannot be seen by the user before or during use.

The Abiomed Impella 5.5 Smart Assist Set heart pump contains an introducer sheath that may leak under the cap or along hub seams. This manufacturing defect is not visible to the user but is present in all affected pump sets. The issue affects 383 units distributed worldwide.

Abiomed has recalled certain Introducer Kit 23 Fr units (Pump Set Code 1000441) due to a potential for sheath leakage from under the sheath cap and along hub score lines. This manufacturing issue cannot be seen by the user and affects introducers included in every pump set.

Abiomed has recalled the Impella CP Introducer Kit (Pump Set Code 1000550) worldwide due to a potential for fluid leakage from under the sheath cap and along hub score lines in the 14Fr and 23Fr introducers. The leakage defect is not visible to the user and affects all current batches of this heart pump accessory kit.

Abiomed has recalled the Impella CP heart pump introducer due to a manufacturing defect that can cause fluid leakage from under the sheath cap and along the hub. The defect is not visible to the user and affects all current batches worldwide.

The Abiomed Impella RP Flex heart pump set includes introducers that may leak fluid from under the sheath cap or along hub score lines due to manufacturing defects. These leaks cannot be seen by visual inspection. All current batches worldwide are affected.

Abiomed has recalled certain Impella CP Sets with SmartAssist (10th Generation) that contain affected 14Fr Low Profile Introducer Kits due to a potential for blood clot (thrombus) formation during prolonged use of the introducer. The affected units were distributed in the US and Japan.

Certain lots of the Abiomed Impella CP Set with SmartAssist (10th Generation) and its 14Fr Low Profile Introducer Kit may form blood clots during extended use. The affected units have specific serial numbers and batch numbers listed by the FDA. No injuries have been reported.

Abiomed has recalled certain low-profile introducer kits used with its Impella CP heart support device due to a potential risk of blood clot (thrombus) formation during prolonged use. The recall affects 17 units distributed in select US states and Japan.

Abiomed's 14 Fr x 13 cm Low Profile Introducer Kit for the Impella CP heart pump may increase the risk of blood clot (thrombus) formation during extended use. Three units have been distributed to hospitals in the US and Japan.

Abiomed's Impella CP Set with SmartAssist may experience low purge pressure issues that trigger repeated alarms. In some cases, this malfunction can interrupt or stop the device's mechanical heart support function.

A software error in certain Automated Impella Controller devices (used to manage left heart support blood pumps) may affect device function. The error affects controllers with software versions 6.0.1, 6.0.2, 6.0.3, 7.1 and above across multiple regions worldwide.

Certain Impella Controller (AIC) consoles contain electrical faults including alarm failures, power-path problems, and inaccurate motor sensing. Additionally, improper alignment between the purge cassette and motor drive can prevent the purge system from priming correctly, requiring users to switch to a backup console.

Abiomed identified that certain Automated Impella Controller (AIC) units have internal hardware issues that could affect device operation. These include cable and component positioning problems that may interrupt motor controls, cause startup failures, or prevent the device from booting properly. Abiomed is implementing hardware updates through its servicing process.

Abiomed's Impella Controller may display a delayed "Purge System Blocked" alarm when used with first-generation Impella 5.5 pumps. This could prevent timely detection of a blocked purge system. The issue affects 62 controllers with specific serial numbers in software versions 8.2.2 through 8.5.

Abiomed is recalling purge cassettes used in Impella heart pump systems because Generation 1 cassettes have an increased risk of leaking during use. This affects multiple Impella pump models sold globally, with specific batch numbers identified from 2024.

The differential pressure sensor in some Abiomed Impella RP heart pump devices may malfunction, causing inaccurate sensor readings. This affects 179 units distributed worldwide. No injuries have been reported to date.

The differential pressure sensor in some Abiomed Impella RP Flex with SmartAssist heart pump devices may malfunction, causing inaccurate sensor readings. This is a Class I recall affecting approximately 4,496 devices distributed worldwide. No injuries have been reported to date.

The differential pressure sensor in certain Abiomed Impella RP heart pump devices may malfunction and provide inaccurate readings. This could affect the device's ability to monitor and respond appropriately during use. About 291 devices worldwide are affected.

Abiomed has recalled 2 units of the Impella 5.5 with SmartAssist S2 heart pump device because the devices were shipped in incorrect outer box cartons. This packaging error may affect proper device identification and handling. No injuries have been reported.

Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.

Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).

Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm.