Abiomed, Inc. recalls
31 recalls in our records from 2019 to 2026: 31 FDA medical devices.
Recalls with full detail pages
-
Abiomed, Inc. medical device recall: Automated Impella Controller
The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
-
Abiomed, Inc. medical device recall: 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…
-
Abiomed, Inc. medical device recall: Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP.…
Potential for thrombus formation during prolonged use of the introducer.
-
Abiomed, Inc. medical device recall: Impella CP Set with SmartAssist. Product Codes: 1000080
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…
-
Abiomed, Inc. medical device recall: Automated Impella Controller
Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
-
Abiomed, Inc. medical device recall: Automated Impella Controller
Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were…
-
Abiomed, Inc. medical device recall: Automated Impella Controller
A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been…
-
Abiomed, Inc. medical device recall: Purge Cassette
Increased risk of purge leaks with Generation 1 purge cassettes.
-
Abiomed, Inc. medical device recall: Automated Impella Controller
Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*)…
-
Abiomed, Inc. medical device recall: Impella RP with SmartAssist. Product Code: 0046-0035
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
-
Abiomed, Inc. medical device recall: Automated Impella Controller
Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
-
Abiomed, Inc. medical device recall: Automated Impella Controller
Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
-
Abiomed, Inc. medical device recall: Automated Impella Controller
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…
-
Abiomed, Inc. medical device recall: Automated Impella Controller
A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected
-
Abiomed, Inc. medical device recall: Impella RP with SmartAssist
Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of…
Earlier and other recalls
These link to the official agency notice.
-
Abiomed, Inc. medical device recall: Automated Impella Controller Official notice ↗
Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and…
-
Abiomed, Inc. medical device recall: Impella 5.5 with SmartAssist¿ S2 Official notice ↗
Device packaged in incorrect outer box carton.
-
Abiomed, Inc. medical device recall: Impella CP Smart Assist Set Official notice ↗
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed…
-
Abiomed, Inc. medical device recall: Impella CP with SmartAssist Official notice ↗
Nine (9) Impella CP pumps failed inspection and were inadvertently released.
-
Abiomed, Inc. medical device recall: Automated Impella Controller Official notice ↗
Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software Update Available. The update resolved an issue in version 8.4 where a…
-
Abiomed, Inc. medical device recall: Impella catheters - Intravascular micro axial blood pumps that… Official notice ↗
IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.
-
Abiomed, Inc. medical device recall: Impella catheters - Intravascular micro axial blood pumps that… Official notice ↗
New warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may result in…
-
Abiomed, Inc. medical device recall: Abiomed Axillary Insertion Introducer -Introducer(s) are intended for… Official notice ↗
Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes…
-
Abiomed, Inc. medical device recall: Impella Connect Official notice ↗
The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: Notifications via…
-
Abiomed, Inc. medical device recall: Automated Impella Controller Official notice ↗
Pump not detected as connected to controller due to software issue.
-
Abiomed, Inc. medical device recall: Impella RP Flex with SmartAssist intracardiac microaxial blood pump Official notice ↗
A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling central venous lines or…
-
Abiomed, Inc. medical device recall: Impella 2.5 intravascular micro axial blood pump Official notice ↗
There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting…
-
Abiomed, Inc. medical device recall: Abiomed 14Fr Low Profile Introducer Set Official notice ↗
There was one complaint that the sidearm of the device detached during explant of a pump. When the sidearms are subjected to heat, humidity and articulation, a silicone…
-
Abiomed, Inc. medical device recall: Impella 5.5 with SmartAssist catheter is an intravascular micro axial… Official notice ↗
The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.
-
Abiomed, Inc. medical device recall: OXY-1 System Official notice ↗
The firm has received complaints of the OXY-1 System Console experiencing a power interruption while in use, which disrupts therapy delivered to a patient on support.…
-
Abiomed, Inc. medical device recall: lmpella CP with Smart Assist Official notice ↗
This one pump shipped with incorrect pump programming, the initial production working version of the program. The pump would have immediately run at P9 for all selected…
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.