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)
Reported: May 24, 2023 Initiated: April 17, 2023 #Z-1590-2023
Product Description
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)
Reason for Recall
The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.
Details
- Recalling Firm
- Abiomed, Inc.
- Units Affected
- 610 units
- Distribution
- US Nationwide. Japan, Saudi Arabia, Kuwait, Italy, Spain, Switzerland, Austria, France, Great Britain, Croatia, Serbia, Norway, Slovenia, Germany
- Location
- Danvers, MA
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Abiomed, Inc.. Units affected: 610 units.
Why was this product recalled? ▼
The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 24, 2023. Severity: Critical. Recall number: Z-1590-2023.
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