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Open, Classified

Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU.

FDA Recall Z-1030-2026 · Posted 2026-01-08

Recalling FirmAbiomed, Inc.
Recall StatusOpen, Classified
Product CodeOZD
Date Initiated2025-12-04
Product Quantity6 units

Reason for Recall

Device packaged in incorrect outer box carton.

Firm Action

The consignee was sent a RECALL notice dated 12/4/25. The consignee is instructed to identify the two affected pumps in their inventory, quarantine them, and return the units to Abiomed, Danvers. The consignee is to complete and return the provided business reply form to their local Abiomed representative.

Root Cause

Under Investigation by firm

Distribution Pattern

International distribution to the country of Australia and Taiwan.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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