Manufacturer
75 recalls in our database name Abiomed, Inc. as the manufacturing or recalling firm.
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.
Pending LLM rewrite. Source: FDA_DEVICE Z-1470-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1030-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0136-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0069-2026.
Abiomed is recalling specific Automated Impella Controllers with defective Pump Driver Circuit Assemblies that may cause decreased pump performance or pump stop. The defect triggers Impella Failure or Impella Stopped Controller Failure alarms.
Pending LLM rewrite. Source: FDA_DEVICE Z-2164-2025.
Abiomed is recalling 2,364 units of the Impella RP Flex with SmartAssist due to risk of optical sensor damage from device interaction. Damage may cause temporary or permanent pump stop and loss of vital monitoring signals.
Abiomed is recalling 1,560 units of the Impella RP with SmartAssist pump due to risk of optical sensor damage from device interactions. Damaged sensors may cause temporary or permanent pump malfunction.
Abiomed is updating labeling for the Impella CP Smart Assist Set to warn about a potential interaction with the Shockwave Coronary IVL Catheter when used during coronary interventions. The interaction was previously undocumented in the device instructions.
Abiomed is recalling the Impella CP Pump Set due to a potential device interaction with the Shockwave Coronary IVL Catheter during coronary interventions. The manufacturer will update device instructions to address this interaction.
Abiomed updated Impella 5.5 cardiac pump labeling to document a potential interaction with Shockwave Coronary IVL Catheter during coronary procedures. No injuries have been reported.
Abiomed is updating labeling for Impella 5.5 cardiac support pumps to include information about a potential device interaction with Shockwave Coronary IVL Catheters during coronary interventions.
The FDA is recalling Impella CP Smart Assist Sets due to a potential device interaction with Shockwave Coronary IVL Catheters used during coronary interventions. Abiomed will update device labeling to inform users about this interaction.
Abiomed is updating labeling for the Impella 5.5 SmartAssist S2 cardiac assist device to address a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions.
Abiomed's Pump 381 Pump Set labeling lacks information about potential interactions with Shockwave Coronary IVL Catheters during coronary interventions. The manufacturer is updating instructions for use to address this gap.
Abiomed recalled 413 units of Impella 5.5 with SmartAssist S2 pumps worldwide due to a potential undocumented interaction with Shockwave coronary catheters during cardiac procedures. The company will update product labeling to disclose this interaction.
Abiomed is updating documentation for the Impella 5.5 cardiac pump to address a potential device interaction with the Shockwave Coronary IVL Catheter during coronary procedures. The notice affects 21 units distributed worldwide.
Abiomed is updating labeling for ImpellaCP SmartAssistSetAPAC to address a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions. Eight units were distributed worldwide.
Abiomed is updating labeling for Impella CP Smart Assist pumps to address a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions. The interaction was previously undocumented in device labeling.
Abiomed is updating labeling for the Impella CP Smart Assist Set to address a potential device interaction with the Shockwave Coronary IVL Catheter during coronary procedures.
Abiomed is recalling the Impella CP Pump 371 Set due to a potential device interaction with the Shockwave Coronary IVL Catheter. The manufacturer is updating labeling to address this interaction. No illnesses or injuries have been reported.
Abiomed is updating labeling for Impella 5.5 with SmartAssist Set due to a potential device interaction with Shockwave Coronary IVL Catheter during coronary interventions. The product labeling currently lacks information about this potential interaction.
Abiomed is updating labeling for the Impella CP Smart Assist Set to address a potential device interaction with the Shockwave Coronary IVL Catheter during coronary procedures. No illnesses or injuries have been reported.
Abiomed is recalling 9 Impella CP with SmartAssist heart pump units that failed inspection and were inadvertently released. The devices were distributed in Florida, Massachusetts, Ohio, and Texas.
Abiomed is releasing software Version 8.5 for the Automated Impella Controller to fix an issue in versions 8.4 and 8.4.1 where the device failed to recognize the pump. Approximately 4,463 units were distributed nationwide.