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CARTO VIZIGO Sheath (Biosense Webster) – Manufacturing Mix-Up (2024)

Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.

Moderate

FDAFeb 16, 2024Nationwide• Biosense Webster, Inc.

Neonatal ArcticGel Pads (Medivance) – Water Flow Issue (2024)

Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling performance of the pads that are part of a temperature management system.

Moderate

FDAFeb 16, 2024Nationwide• Medivance Inc.

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CARTO VIZIGO Sheath (Biosense Webster) – Manufacturing Mix-Up (2024)

Neonatal ArcticGel Pads (Medivance) – Water Flow Issue (2024)

Origio Sperm Wash Medium (CooperSurgical) – Sodium Pyruvate Risk (2024)

Abre Venous Stent System (Medtronic) – Package Breach (2024)

Rad-G Pulse Oximeter (Masimo) – Power Monitoring Risk (2024)

DIVA LCD Display (Philips) – Touch Input Malfunction (2024)

QXDx BCR-ABL Kit (Bio-Rad) – Calibration Inaccuracy (2024)

HotDog Return Electrode (Augustine) – Electrode Contact Issue (2024)

Rad-G Pulse Oximeter (Masimo) – Power Monitoring Risk (2024)

Mariner RDX Head (SeaSpine) – Screw Threading Risk (2024)

STERIS Traction Boot (Baxter) – Locking Pin Defect (2024)

Covidien Signia Reload (Unknown) – Staple Line Disruption (2024)

Cystatin C Calibrator (Randox) – Bias Concern (2024)

Signia Curved Tip Reload (Unknown) – Staple Line Disruption (2024)

GeoMed Tracecarts (DeRoyal) – Component Recall Risk (2024)

TMini Knee Instrument (Think Surgical) – Array Guide Issue (2024)

QuickFlash Artery Catheterization (Arrow) – Component Defect (2024)

POLARSHEATH Steerable Sheath (Boston Scientific) – Manufacturing Defect (2024)

Curaplex Intubation Kit (Sarnova) – Tube Holder Incompatibility (2024)

Nobel Active Titanium Blank (Preat) – Screw Engagement Risk (2024)