Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Reported: July 24, 2024 Initiated: May 31, 2024 #Z-2319-2024
Product Description
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Reason for Recall
Nine (9) Impella CP pumps failed inspection and were inadvertently released.
Details
- Recalling Firm
- Abiomed, Inc.
- Units Affected
- 9 units
- Distribution
- Domestic only: FL, MA, OH TX.
- Location
- Danvers, MA
Frequently Asked Questions
What product was recalled? ▼
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump. Recalled by Abiomed, Inc.. Units affected: 9 units.
Why was this product recalled? ▼
Nine (9) Impella CP pumps failed inspection and were inadvertently released.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 24, 2024. Severity: Critical. Recall number: Z-2319-2024.
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