Every recall we track for Abiomed, Inc. — 78 in all — plus the complaints and injury reports the public filed about them.
Abiomed recalls 23Fr 11cm Introducer Kits with potential sheath leakage due to manufacturing defects. Affected units may leak under the sheath cap and along hub score lines, but no injuries reported. Consumers should contact Abiomed for details.
Abiomed recalls Impella CP Smart Assist Set (Pump Set Code 0048-0024-JP) due to potential introducer sheath leakage. This risk may cause complications during medical procedures. Affected units include all current batches in field.
Abiomed recalls 14Fr and 23Fr introducer kits due to potential sheath leakage from under the sheath cap and along hub score lines. This issue is not visible to users and affects all current pump sets.
Abiomed recalls Impella 5.5 Smart Assist Set (Pump Set Codes 1000211, 1000212) due to potential introducer sheath leakage. This risk may cause complications during medical procedures. Affected users should contact Abiomed for details.
Abiomed recalls Impella CP pump sets with potential introducer sheath leakage. Affected units include Pump Set Code 0048-0044 and Introducer Product Code 0052-3046. No remedy specified in official notice.
Abiomed recalls Impella RP Flex pump sets with potential introducer sheath leakage. This may cause complications during medical procedures. Affected units include specific pump set codes.
Abiomed recalls Impella 5.5 SmartAssist S2 Set (Pump Set Codes 1000459, 1000460) due to potential introducer sheath leakage. This could cause complications during medical procedures.
Abiomed recalls Impella CP Introducer Kit 14Fr models due to potential sheath leakage from under the sheath cap and along hub score lines. This issue is not visible to users and affects all current batches.
Abiomed recalls Impella CP pump sets with potential introducer sheath leakage. Affected units have specific product codes and batch numbers. Contact for remedy details.
Abiomed recalls heart pump kits with potential introducer sheath leakage. This risk may cause complications during medical procedures. Affected kits include specific product codes and all current field batches.
Abiomed recalls Impella CP Introducer Kit 14Fr models due to potential sheath leakage from under the sheath cap and along hub score lines. This issue is not visible to users and may cause complications during medical procedures.
Abiomed recalls Impella CP Introducer Kit 14Fr models due to potential sheath leakage from under the sheath cap and along hub score lines. This issue is not visible to users but may cause complications during medical procedures.
Abiomed recalls Impella CP Set (Code 0048-0003) due to potential introducer sheath leakage. This risk may cause complications during heart pump procedures. Affected units include specific model sizes.
Abiomed recalls Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits due to potential blood clot formation during long-term use. Affected units have specific product codes and batch numbers.
Abiomed recalls 14 Fr x 13 cm Low Profile Introducer Kits for Impella CP due to potential blood clot formation during long-term use. Affected units have specific product codes and batch numbers.
Abiomed recalls 14 Fr x 2:25 cm Low Profile Introducer Kits for Impella CP due to potential blood clot formation during long-term use. Affected units have specific product codes and batch numbers.
Abiomed recalls 10th Gen Impella CP Set with SmartAssist containing affected 14Fr Low Profile Introducer Kits due to potential blood clot formation during long-term use. Product codes and serial numbers listed for identification.
Abiomed recalls Impella CP Set with SmartAssist (product codes 1000080, 1000851, 0048-0014, 0048-0024-JP) due to potential persistent low purge pressure alarms and interruption of mechanical circulatory support.
Abiomed is a leading medical device manufacturer specializing in cardiovascular and surgical products. We provide innovative solutions for healthcare professionals.
Abiomed recalls Automated Impella Controller units without recent hardware updates to prevent potential motor control interruptions, startup failures, and console boot-up issues.
Abiomed is a leading manufacturer of medical devices and equipment, specializing in cardiovascular and vascular products. Their products include heart valves, catheters, and other critical medical devices.
Abiomed recalls Automated Impella Controllers with software versions 8.2.2-8.5 that may delay 'Purge System Blocked' alarms when used with first-gen Impella 5.5 pumps. Affected units include specific product codes and serial numbers.
Abiomed recalls Impella RP devices with product code 0046-0011 due to potential sensor malfunction causing inaccurate readings. Affected units distributed outside the US.
Abiomed recalls Impella RP with SmartAssist devices (product code 0046-0035) due to potential sensor value drift affecting medical monitoring.
Abiomed recalls Impella RP Flex with SmartAssist (Product Code 1000323) due to potential sensor drift causing inaccurate readings. Affected units may require monitoring or repair.
Abiomed recalls Impella 5.5 with SmartAssist S2 devices due to incorrect outer packaging. Affected units have specific serial numbers and Australian configuration codes. No action is required as the packaging error does not affect safety.
Abiomed recalls Automated Impella Controllers (AIC) due to potential cybersecurity vulnerabilities in the operating system. Affected models include various international versions with specific product codes and serial numbers.
Abiomed is a leading manufacturer of medical devices, specializing in cardiovascular and surgical equipment. Their products include heart valves, catheters, and surgical instruments.
Abiomed recalls specific Impella Controllers that may cause pump stoppage or failure alarms when used with heart assist pumps. Affected units have unique product codes and serial numbers.
Abiomed recalls Automated Impella Controllers (AIC) used in left heart support pumps due to potential failure to detect connected pumps. Affected models include various international versions with specific product codes and serial numbers. No remedy is listed in the recall notice.
Abiomed recalls Impella RP with SmartAssist pumps with serial numbers listed. Optical sensors may be damaged during device insertion or manipulation, causing temporary or permanent pump stoppage.
Abiomed is a leading manufacturer of medical devices and products, specializing in cardiovascular and vascular solutions. Their products include surgical instruments, catheters, and other medical equipment used in various healthcare settings.
Abiomed recalls Impella 5.5 Set AU (Product Code 1000361) due to potential interaction with Shockwave Coronary IVL Catheters during heart procedures. No immediate action is required but updated instructions will be provided.
Abiomed, Inc. is a leading medical device manufacturer specializing in innovative cardiovascular and surgical solutions. We provide high-quality products for healthcare professionals worldwide.
Abiomed recalls Japan-sold Impella CP Pump Sets (Product Code 0048-0034-JP) due to potential interaction with Shockwave Coronary IVL Catheters during heart procedures. No immediate action needed as labeling update is pending.
Abiomed is a leading manufacturer of medical devices, specializing in cardiovascular and vascular products.
Abiomed recalls Impella 5.5 with SmartAssist Set due to potential interaction with Shockwave Coronary IVL Catheter during procedures. No immediate action needed per current labeling, but updated instructions will address the risk.
Abiomed recalls Impella 5.5 with SmartAssist S2 Set (EU) due to potential device interaction during coronary interventions. No current labeling addresses this risk, but updated instructions will be provided.
Abiomed recalls specific Impella CP Smart Assist Set models in Canada due to potential interaction between Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. No immediate action required as labeling update is pending.
Abiomed, Inc. is a leading medical device manufacturer specializing in innovative cardiovascular and surgical solutions. Their products include a wide range of devices for cardiac and vascular procedures.
Abiomed is a leading manufacturer of medical devices, specializing in cardiovascular and surgical equipment. Their products include heart valves, catheters, and other critical medical tools.
Abiomed recalls Impella 5.5 SmartAssist S2 Set (Product Code 1000459) due to potential interaction with Shockwave Coronary IVL Catheters during heart procedures. No immediate action needed but updated instructions will be provided.
Abiomed recalls Impella CP Smart Assist Set (Product Code 1000402) due to potential device interaction with Shockwave Coronary IVL Catheters during heart procedures. No immediate action needed but updated instructions will be provided.
Abiomed recalls Impella CP Smart Assist Set APAC (Product Code 0048-0047) due to potential interaction with Shockwave Coronary IVL Catheters during procedures. No current labeling addresses this risk, so Abiomed will update instructions.
Abiomed is a leading manufacturer of medical devices, specializing in innovative solutions for cardiovascular and surgical applications.
Abiomed is a leading manufacturer of medical devices, specializing in cardiovascular and surgical equipment. Their products include catheters, stents, and other critical medical devices.
Abiomed recalls Impella 5.5 SmartAssist Set (Product Code 1000211) due to potential device interaction with Shockwave Coronary IVL Catheter during coronary interventions. Abiomed will update the IFU to include this interaction information.
Abiomed recalls Impella CP Pump 371 Set (Product Code 0048-0040) due to potential interaction with Shockwave Coronary IVL Catheter during procedures. No immediate action needed but updated instructions will be provided.
Abiomed recalls ImpellaCP SmartAssistSetAPAC models with potential device interaction during coronary interventions. No immediate action needed but updated instructions will address the risk.
Abiomed recalls 9 Impella CP SmartAssist blood pumps (Product No. 1000080) that failed inspection. These pumps may have been released without proper safety checks.
Abiomed recalls Impella 2.5, 5.0, 5.5 and other catheters due to potential left ventricle perforation from improper handling. Affected units include specific product codes and sets. No action needed if device is properly used.
Abiomed recalls Impella catheters (2.5, 5.0, LD, RP, CP models) due to updated warnings to reduce fiber risk that could cause low blood flow. All affected products have new instructions.
Abiomed recalls Impella Connect software portal version 1.1-3.17.1 due to disabled safety features. Users may face risks from unmonitored device alerts.
Abiomed recalls certain Introducer Kits that may have holes in the sterile pouch, risking infection. Affected kits could expose patients to microorganisms, leading to sepsis or bacteremia.
Abiomed recalls certain Introducer Kits due to potential sterile barrier compromise, risking infections. Affected kits may expose patients to microorganisms, leading to sepsis or bacteremia. Consumers should contact Abiomed for details.
Abiomed recalls sterile introducer kits that may have holes compromising the sterile barrier, risking infection. Affected kits could expose patients to microorganisms, leading to sepsis or bacteremia.
Abiomed recalls Oscor Introducer Kits (14Fr x Short Individual) due to potential breach in sterile packaging that could lead to infections. Affected units sold with part number 0052-3014. Consumers should contact Abiomed for details.
Abiomed recalls 14Fr Introducer Kits with potential sterile barrier holes that could cause infections. Affected kits may lead to bacteremia or sepsis if used without proper sterility.
Abiomed recalls certain Oscor Introducer Kits due to potential hole in sterile packaging that could allow bacteria into the bloodstream, causing infection. Affected kits may need replacement to prevent sepsis.
