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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This involves a Class II medical device used for critical circulatory support. Although no illnesses or injuries have been reported, the potential for device malfunction (low flow) resulting from fiber ingestion poses a risk of harm. As a precautionary warning addition to a risk-of-harm device, this meets the criteria for High severity.
Plain-English summary
Abiomed is adding new safety warnings to the Instructions for Use (IFU) for all Impella catheter models. Impella catheters are intravascular micro axial blood pumps designed to provide circulatory support to patients.
The new warnings are being added to reduce the possibility of fibers being drawn into the Impella catheter, which may result in low flow of the device. This precautionary measure is intended to enhance patient safety.
The warning applies to all affected Impella catheter models and variants, including Impella 2.5, 5.0, LD, RP, CP, 5.5 with SmartAssist, and RP Flex with SmartAssist. Approximately 92,515 units have been distributed worldwide, including to the United States, Australia, Canada, Germany, France, India, Mexico, Taiwan, and the U.S. Virgin Islands.
Patients and healthcare providers with Impella catheters should consult the updated Instructions for Use to review the new safety warnings and understand the precautions needed to prevent fiber entry into the device.
The recalled product
- 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
- Manufacturer
- Abiomed, Inc.
- Hazard
- fiber-ingestion
- device-malfunction
Distribution
Distributed nationwide across the United States.
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