Abiomed, Inc. recalls
30 federal recalls on file, showing the 13 from the last 12 months. We read every CPSC, FDA, USDA and NHTSA notice for Abiomed, Inc. and put it in plain English.
Recent recalls
Abiomed Impella controllers recalled for hardware and software issuesAbiomed is recalling 900 Impella heart pump controllers in three products: Automated Impella Controller, Impella Optical Controller, and Impella Connect Optical AIC. The units need hardware, firmware, or software updates found during a review of servicing records. Possible problems include the controller failing to recognize the purge cassette, a sticking push button that can cause loss of console control, start-up failure, and a software defect that can show incorrect negative pressure readings. No injuries have been reported.
SeriousFDAOct 28, 20263 products
- Abiomed Impella Controller recalled for firmware defects
Abiomed has issued a retrospective recall of certain Automated Impella Controller (AIC) units manufactured before 2019. The devices contain firmware and software defects that can affect the accuracy of pressure signals, cause unreliable placement detection, and trigger false alarms. These issues were remedied through firmware and software patches released in 2019.
ModerateFDASep 30, 2026
- Abiomed Impella controllers recalled for purge sensor risk
Abiomed is recalling three groups of Impella controllers, about 10,750 units in total, that are used with heart pump systems. A component in the purge pressure sensor assembly, the purge flag, can fail, which may stop the controller from correctly recognizing the purge cassette. No injuries have been reported.
SeriousFDASep 23, 20263 products
- Abiomed Impella heart pump introducers recalled for leakage risk
Abiomed is recalling 13 Impella heart pump sets and introducer kits because the introducer sheath may leak from under the sheath cap and along the hub score lines. The problem affects 14Fr and 23Fr introducers, which come in every pump set, and users cannot see it visually. No injuries have been reported.
SeriousFDAJul 22, 202613 products
- Abiomed Impella CP introducer kits recalled for clot formation risk
Abiomed is recalling four Impella CP product sets that include 14 Fr Low Profile Introducer Kits, with 195 affected units in total. The introducer may form blood clots (thrombus) during prolonged use. No injuries have been reported, and the distribution covers the US states of FL, IL, MN, NJ, NY, and VA, plus Japan.
SeriousFDAJul 1, 20264 products
- Abiomed Impella CP Set recalled for low purge pressure risk
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.
SeriousFDAJun 24, 2026
- Abiomed Impella Controller recalled for software error
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.
SeriousFDAJun 24, 2026
- Abiomed Impella Controller recalled for electrical and priming risks
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.
SeriousFDAJun 3, 2026
- Abiomed Impella Controller recalled for potential safety concerns
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.
SeriousFDAJun 3, 2026
- Abiomed Impella Controller recalled for possible delayed alarm
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.
SeriousFDAApr 8, 2026
- Abiomed Impella Generation 1 purge cassettes recalled for leak risk
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.
SeriousFDAApr 8, 2026
- Abiomed Impella RP heart pumps recalled for sensor drift risk
Abiomed is recalling three Impella RP heart pump models because the differential pressure (dP) sensor may malfunction and its readings may drift. The recall covers 4,966 units in total and was distributed in the US and several other countries. No injuries have been reported.
SeriousFDAMar 11, 20263 products
- Check Abiomed Impella 5.5 packaging
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.
ModerateFDAJan 14, 2026