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Abiomed, Inc. alerts

Verified recalls, refunds, lawsuits, and settlements involving Abiomed, Inc..

Recall Active FDA Official source

Abiomed, Inc.: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile...

Potential for thrombus formation during prolonged use of the introducer. Product details: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile...

Company: Abiomed, Inc.
Deadline: No deadline listed
Source: U.S. Food and Drug Administration

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Recall Active FDA Official source

Abiomed, Inc.: Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP. Recall

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 support. Product...

Company: Abiomed, Inc.
Deadline: No deadline listed
Source: U.S. Food and Drug Administration

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Recall Active FDA Official source

Abiomed, Inc.: Automated Impella Controller (AIC) with the below product descriptions and corresponding...

Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC...

Company: Abiomed, Inc.
Deadline: No deadline listed
Source: U.S. Food and Drug Administration

View affected products Official source