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Abbott Proclaim 5 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

Abbott Proclaim DRG 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

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

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

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

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

BIOFIRE FILMARRAY GI Panel (BioFire) – False Positive Results (2024)

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

Philips Allura Xper FD10 System (PHILIPS) – Brake Engagement Issue (2024)

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

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

Estradiol Patch (Zydus) – Specification Failure (2024)

Estradiol Patch (Zydus) – Specification Failure (2024)

Pregabalin Capsules (Rising Pharma) – Foreign Tablet Found (2024)

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

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

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

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

Ultrathane Cook-Cope Drainage Catheter (Cook) – Incorrect Expiration (2024)

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

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

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