Impella 5.5 with SmartAssist Catheter Recalled for Heightened Purge Leak Rate
Abiomed is recalling 610 units of the Impella 5.5 with SmartAssist catheter due to a heightened complaint rate for purge leaks. This intravascular pump provides circulatory support during critical care.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA classification for this device is Class I, which establishes a minimum severity level of Severe. The heightened complaint rate for purge leaks in a critical circulatory support device represents a significant safety concern, though no deaths or injuries are reported in the source.
Plain-English summary
The Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump designed to provide circulatory support during critical care. Abiomed is recalling 610 units due to a heightened complaint rate for purge leaks in the device.
The affected units include three product variants: Impella 5.5 JP (product number 1000211), Impella 5.5 Smart Assist (product number 0550-0002), and Impella 5.5 with SmartAssist Set for US (product number 0550-0008). Each variant has specific serial numbers identified in the recall notice.
These devices are distributed nationwide in the United States and internationally in Japan, Saudi Arabia, Kuwait, Italy, Spain, Switzerland, Austria, France, Great Britain, Croatia, Serbia, Norway, Slovenia, and Germany. Healthcare providers who have obtained these devices should verify the serial numbers against the FDA recall list. Patients and clinicians should contact Abiomed or their healthcare facility for guidance regarding affected units.
The recalled product
- Product
- Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart Assist), and 0550-0008 (Impella 5.5 with SmartAssist Set, US)
- Manufacturer
- Abiomed, Inc.
- Hazard
- Affected units
- 610
Distribution
Distributed nationwide across the United States.
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