Manufacturer

Abiomed, Inc.

75 recalls in our database name Abiomed, Inc. as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–75 of 75

SevereFDA (Devices)·Z-0980-2024·2024-02-21
Impella Cardiac Support Catheters: Risk of Left Ventricle Perforation
Impella cardiac catheters are being recalled due to risk of left ventricle perforation during operator use. The FDA has classified this Class I recall affecting 91,914 units worldwide.
Product
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 wit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1074-2024·2024-02-21
Impella Catheters: Warnings Added for Potential Fiber Ingestion Risk
Abiomed is adding safety warnings to Instructions for Use for all Impella catheter models to prevent fibers from entering the device, which could result in reduced flow. The warning applies to all Impella models distributed worldwide.
Product
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (4) Product Code 004334 - Impella RP (5) Product Code 0046-0035
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0647-2024·2024-01-17
Abiomed Oscor Introducer Kit Recalled Due to Sterile Barrier Compromise
Abiomed is recalling its Oscor Introducer Kit due to holes in the outer pouch that may compromise the sterile barrier. Non-sterile introducers could expose patients to infection, bacteremia, or sepsis.
Product
Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3014
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0652-2024·2024-01-17
Abiomed Introducer Kit Sterile Barrier Compromise Due to Pouch Defect
Abiomed Introducer Kits may have holes in outer pouches that compromise sterility, exposing patients to bacterial contamination and risk of infection, bacteremia, or sepsis.
Product
Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3046
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0646-2024·2024-01-17
Medical Device Recall: Abiomed Axillary Insertion Introducer Sterile Barrier Breach
Abiomed Axillary Insertion Introducer Kits have holes in the outer pouch that may compromise sterility, potentially exposing patients to serious infections including bacteremia and sepsis.
Product
Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3006 Individual, and Part of Pump Set (005062, 0550-0008, 1000100, 0052-0011, 1000220)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0649-2024·2024-01-17
Abiomed Introducer Kit recalled due to sterile barrier compromise risk
Abiomed is recalling Introducer Kits (part 0052-3021) with holes in the outer pouch that compromise the sterile barrier, potentially exposing patients to infection. The kits were distributed nationwide and internationally.
Product
Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part Number: 0052-3021. Intended for introduction of the Impella Catheter into the body
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0655-2024·2024-01-17
Abiomed Introducer Kits Recalled for Sterile Barrier Pouch Defect
Abiomed is recalling 84 introducer kits that may have holes in the outer pouch, compromising the sterile barrier. This exposes patients to microbial contamination and risk of serious infections including bacteremia and sepsis.
Product
Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 2000342
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0653-2024·2024-01-17
Oscor Intro Catheter Introducer Kit: Compromised Sterile Barrier
Abiomed is recalling Oscor Intro Introducer Kits due to holes in the outer pouch that may compromise the sterile barrier, potentially exposing patients to harmful bacteria and infections including bacteremia and sepsis.
Product
Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3025
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0651-2024·2024-01-17
Abiomed Introducer Kit Recalled for Compromised Sterile Barrier
Abiomed is recalling introducer kits due to holes in the outer pouch that compromise the sterile barrier. Non-sterile product could allow microbial contamination, leading to infection such as bacteremia or sepsis.
Product
Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-0053
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0648-2024·2024-01-17
Abiomed Oscor Introducer Kit sterile barrier holes risk infection
Abiomed Oscor Introducer Kits may have holes in the outer pouch that compromise sterility. This could allow bacteria to enter the patient's bloodstream during catheter insertion.
Product
Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3015
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0650-2024·2024-01-17
Abiomed Introducer Kit Sterile Barrier Compromise Risks Infection
Abiomed introducer kits may have holes in the outer pouch, compromising sterility and exposing patients to potential microbial contamination. This could lead to serious infections including bacteremia or sepsis.
Product
Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3052
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0654-2024·2024-01-17
Abiomed Introducer Kits recalled due to sterile barrier compromise
Abiomed is recalling Introducer Kits because holes in the outer pouch may compromise the sterile barrier, risking bacterial infection. The kits are distributed nationwide and internationally.
Product
Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, 0048-0032)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3056
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0636-2024·2024-01-10
Impella Connect medical device software portal disables unevaluated features
Abiomed has disabled four features in the Impella Connect software portal because the FDA has not evaluated them for safety and effectiveness.
Product
Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0441-2024·2023-12-13
Automated Impella Controller Software Defect Affecting Pump Connection Detection
Abiomed is recalling Automated Impella Controller units with software versions V8.4 and V8.4.1 because a software issue may prevent proper pump connection detection. Affected devices were distributed in Arizona, California, Florida, New York, and Virginia.
Product
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0440-2024·2023-12-13
Automated Impella Controller Software Issue Prevents Pump Detection
Abiomed is recalling Automated Impella Controller (AIC) software versions V8.4 and V8.4.1 due to a software issue that may prevent the pump from being detected as connected to the controller. Devices were distributed in Arizona, California, Florida, New York, and Virginia.
Product
Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
Category
Medical Device
Distribution
5 states
SevereFDA (Devices)·Z-2281-2023·2023-08-09
Impella RP Flex cardiac pump recalled for thrombus formation risk
The Impella RP Flex cardiac pump has been recalled due to a higher-than-expected rate of blood clot formation. Blood clots may reduce cardiac support or cause hemolysis.
Product
Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2115-2023·2023-07-26
Impella CP Blood Pump Recalled for Blade Destruction From Stent Interaction
Abiomed's Impella CP cardiac pump can be damaged by interaction with replacement heart valves, potentially causing blood clots. The FDA classified this as a Class I recall of 9,252 units worldwide.
Product
Impella CP intravascular micro axial blood pump, Product Number 0048-0032
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2111-2023·2023-07-26
Impella 2.5 blood pump recalled due to impeller blade damage risk
Impella 2.5 intravascular blood pumps may experience unintended interaction with aortic valve replacement stents, damaging impeller blades and reducing blood flow. Fragments may circulate through the bloodstream.
Product
Impella 2.5 intravascular micro axial blood pump, Product Number 005042
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2113-2023·2023-07-26
Impella LD cardiac pump recalled for impeller damage and embolization risk
Abiomed recalls Impella LD blood pumps due to potential interaction with aortic valve replacement devices that can damage the pump impeller and cause blood clots. Patients with these devices should contact their healthcare provider.
Product
Impella LD intravascular micro axial blood pump, Product Number 005082
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2116-2023·2023-07-26
Impella CP cardiac pump recalls due to motor housing interaction with stents
Abiomed is recalling Impella CP with SmartAssist blood pumps due to risk of motor housing interaction with transcatheter aortic valve replacement devices, which can damage the pump's impeller blades and reduce blood flow.
Product
Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2112-2023·2023-07-26
Impella 5.0 Blood Pump Recalled for Potential Impeller Blade Destruction Risk
Abiomed's Impella 5.0 intravascular blood pump is recalled due to risk of impeller blade destruction when interacting with heart valve replacements. The damaged pump can cause reduced blood flow and potentially release fractured material into the bloodstream.
Product
Impella 5.0 intravascular micro axial blood pump, Product Number 005062
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2114-2023·2023-07-26
Abiomed Impella 5.5 pump recalled due to impeller blade damage risk
Abiomed is recalling the Impella 5.5 with SmartAssist pump due to a risk of impeller blade destruction when used with aortic valve replacement devices. Damage can result in low blood flow and systemic embolization, where broken pump pieces may enter the bloodstream.
Product
Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2128-2023·2023-07-19
Abiomed Introducer Set Recall Due to Sidearm Detachment Risk
Abiomed 14Fr Low Profile Introducer Sets are being recalled due to silicone oil contamination that may cause sidearm detachment during use. One detachment has been documented; no injuries have been reported.
Product
Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1590-2023·2023-05-24
Impella 5.5 with SmartAssist Catheter Recalled for Heightened Purge Leak Rate
Abiomed is recalling 610 units of the Impella 5.5 with SmartAssist catheter due to a heightened complaint rate for purge leaks. This intravascular pump provides circulatory support during critical care.
Product
Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart Assist), and 0550-0008 (Impella 5.5 with SmartAssist Set, US)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0550-2022·2022-02-09
OXY-1 System Console Experiences Power Interruption During Use
OXY-1 System consoles used during cardiac support procedures may experience power interruptions that disrupt patient therapy, potentially causing prolonged oxygen deprivation.
Product
OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump Drive, E Drive, and Pole Mount. The disposable Pump Lung Unit PLU part number 001-0400-100 is sold separately and is not part of this recall.
Category
Medical Device
Distribution
7 states