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Abbott Proclaim XR 7 Pulse Generator (Abbott Medical) – Service Life Concern (2024)

The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.

High

FDAMay 16, 2024Nationwide• Abbott Medical

TourniKwik Tourniquet Set (Medtronic) – Component Placement Error (2024)

Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.

Low

FDAMay 16, 2024Nationwide• Medtronic Perfusion Systems

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Abbott Proclaim XR 7 Pulse Generator (Abbott Medical) – Service Life Concern (2024)

TourniKwik Tourniquet Set (Medtronic) – Component Placement Error (2024)

Abbott Proclaim XR 5 Pulse Generator (Abbott Medical) – Service Life Concern (2024)

Abbott Proclaim 5 Pulse Generator (Abbott Medical) – Service Life Concern (2024)

Inspire Model 3028 Pulse Generator (Inspire Medical) – Electrical Leakage (2024)

Abbott Liberta RC Pulse Generator (Abbott Medical) – System Deactivation (2024)

Abbott Proclaim 7 Pulse Generator (Abbott Medical) – Service Life Concern (2024)

US AquaA 900H Water Purifier (Fresenius) – Concentrate Flow Error (2024)

Abbott Proclaim DRG Pulse Generator (Abbott Medical) – Service Life Concern (2024)

Philips Allura Xper FD20 System (PHILIPS) – Brake Engagement Problem (2024)

Proclaim 7 Elite Pulse Generator (Abbott Medical) – Service Life Concern (2024)

ORIF Hip IM Rodding Femur Kit (American Contract Systems) – EO/ECH Residuals (2024)

Ventilator HAMILTON-C6 (Hamilton Medical) – Sensor Fail Mode (2024)

Knee Arthroscopy Procedure Kit (American Contract Systems) – EO/ECH Residuals (2024)

Arthroscopy Procedure Kit (American Contract Systems) – EO/ECH Residuals (2024)

Arthroscopy Sup Joint Pack (American Contract Systems) – EO/ECH Residuals (2024)

Foot Ankle Procedure Tray (American Contract Systems) – EO/ECH Residuals (2024)

Hand Pack (American Contract Systems) – EO/ECH Residuals (2024)

Artho Knee Beaches Pack (American Contract Systems) – EO/ECH Residuals (2024)

Upper Extremity Procedure Kit (American Contract Systems) – EO/ECH Residuals (2024)