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Impella Connect (Abiomed) – Disabled Portal Features (2023)

The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: Notifications via email feature; AIC alarm color on case tile feature; Sort case tiles by AIC alarm color feature; Pump metric display on case tile feature

Moderate

FDADec 6, 2023Nationwide• Abiomed, Inc.

Peri-Guard Supple (Baxter) – Marketing Brochure Inaccuracy (2023)

Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).

Low

FDADec 6, 2023Nationwide• Baxter Healthcare Corporation

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Impella Connect (Abiomed) – Disabled Portal Features (2023)

Peri-Guard Supple (Baxter) – Marketing Brochure Inaccuracy (2023)

Baxter Ostene Hemostasis Material (Baxter) – Marketing Brochure Inaccuracy (2023)

Vascu-Guard Peripheral Vascular Patch (Baxter) – Marketing Brochure Inaccuracy (2023)

Baxter Floseal Hemostatic Matrix (Baxter) – Marketing Brochure Inaccuracy (2023)

Baxter Coseal Premix (Baxter) – Marketing Brochure Inaccuracy (2023)

Ultrasound EA Table (Oakworks) – Backrest Platform Stress (2023)

Ambu aView 2 A Monitor (Ambu) – Mounting Screw Warning (2023)

CYF-V2 Visera Videoscope (Olympus) – Cleaning Brush Update (2023)

Dover Silicone Foley Tray (Cardinal Health) – Recalled Component (2023)

CYF-V2R Visera Videoscope (Olympus) – Cleaning Brush Update (2023)

Dover Irrigation Tray (Cardinal Health) – Recalled Component (2023)

Dover Silicone Foley Tray (Cardinal Health) – Recalled Component (2023)

Argyle Suction Catheter Tray (Cardinal Health) – Recalled Component (2023)

Dover Silicone Foley Tray (Cardinal Health) – Recalled Component (2023)

CYF-5R Cystonephrofiberscope (Olympus) – Cleaning Brush Update (2023)

ENF-XP Rhino-Laryngofiberscope (Olympus) – Cleaning Brush Update (2023)

CYF-VH Cysto-Nephro Videoscope (Olympus) – Cleaning Brush Update (2023)

Soltive Laser Fibers (Olympus) – Sterile Pouch Seal (2023)

BF-P190 Bronchovideoscope (Olympus) – Cleaning Brush Update (2023)