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Baxter Vascular Probe (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

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.

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Baxter Vascular Probe (Baxter) – Marketing Brochure Inaccuracy (2023)

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

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

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

Ferrara Inferno (Ferrara) – Electrical Wiring Fault (2023)

Baxter Flo-Rester (Baxter) – Marketing Brochure Inaccuracy (2023)

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

Accure Laser System (Accure) – Laser Energy Misalignment (2023)

Trevo Trak 21 Microcatheter (Stryker) – Unapproved Use (2023)

KME Severe Service (KME) – Electrical Wiring Fault (2023)

BMW Z4 (BMW) – Transmission Control Module Issue (2023)

Ducati XDiavel STD (Ducati) – Passenger Backrest Risk (2023)

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

Baxter Preveleak Surgical Sealant (Baxter) – Marketing Brochure Inaccuracy (2023)

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

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

Terberg Terminal Tractor (Terberg) – Steering Linkage Paint (2023)

Foiresoft Zebra Roller Blinds - Strangulation Risk (2023)

Cushman Hauler Pro LSV (Cushman) – Battery Water Damage (2023)

Volvo VHD (Volvo) – Tire Label Issue (2023)