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Impella 5.5 Set AU (Abiomed) – Device Interaction Risk (2024)

A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.

Low

FDAAug 5, 2024Nationwide• Abiomed, Inc.

Impella 5.5 SmartAssist S2 Set JP (Abiomed) – Device Interaction Risk (2024)

Low

FDAAug 5, 2024Nationwide• Abiomed, Inc.

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Impella 5.5 Set AU (Abiomed) – Device Interaction Risk (2024)

Impella 5.5 SmartAssist S2 Set JP (Abiomed) – Device Interaction Risk (2024)

Impella CP Smart Assist Set APAC (Abiomed) – Device Interaction Risk (2024)

Impella CP Pump Set Japan (Abiomed) – Device Interaction Risk (2024)

Pump 371 14F LT CMR Set (Abiomed) – Device Interaction Risk (2024)

Impella CP Smart Assist Set JP (Abiomed) – Device Interaction Risk (2024)

Centricity PACS (GE Healthcare) – Image Storage Limitation (2024)

Impella CP Smart Assist Set (Abiomed) – Device Interaction Risk (2024)

Rubbing Alcohol (Zeco) – Production Water Issue (2024)

Hand Sanitizer (Zeco) – Production Water Issue (2024)

Impella CP Smart Assist Set Canada (Abiomed) – Device Interaction Risk (2024)

Impella CP Pump 371 Set (Abiomed) – Device Interaction Risk (2024)

Impella 5.5 SmartAssist Set EU (Abiomed) – Device Interaction Risk (2024)

ERIC Retrieval Device (MicroVention) – Incorrect Expiration Label (2024)

BARD MAGNUM Biopsy Needle (Bard) – Packaging Damage (2024)

Transcend Econo Kit (Ultradent) – Manufacturing Particulate Issue (2024)

Monarch Platform Endoscopy (Auris Health) – Electrical Short Risk (2024)

Monarch Platform Urology (Auris Health) – Electrical Short Risk (2024)

Vit-l-escence Singles (Ultradent) – Manufacturing Particulate Issue (2024)

BD Phoenix 100 (Becton Dickinson) – E. Coli Misidentification (2024)