Class I — Abiomed, Inc.
| Recalling firm | ABIOMED, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling. |
| 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 (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist (8) Product Code 0048-0032 - Impella CP (9) Product Codes 1000080 and 0048-0045 - Impella CP with SmartAssist ***Updated February 2024*** (10) 004413 - Impella 2.5 Set (12) 0046-0026 - Impella 5.0 Pump Set ROW (13) 0046-0037 - Impella 5.0 Pump Set APAC (15) 004680-AU - 5.0 Pump Set AU (16… |
| Quantity | 91,914 (65,857 US; 26,075 OUS) |
| Distribution | Worldwide distribution - US Nationwide and the countries of AU, CA, DE, FR, IN, MX, TW, and VI. |
| Initiated | 2023-12-27 |
| Classified | 2024-02-09 |
| Recall number | Z-0980-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Abiomed, Inc. (Z-0980-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93749/
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