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LVP Primary Administration Set (Fresenius Kabi) – Medication Flow Risk (2024)

A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose).

High

FDAAug 1, 2024CO, ID, NJ +1 more• Fresenius Kabi USA, LLC

Agile ESO FC RMV 23mm 15.0cm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

High

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

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LVP Primary Administration Set (Fresenius Kabi) – Medication Flow Risk (2024)

Agile ESO FC RMV 23mm 15.0cm (Boston Scientific) – Catheter Tip Detachment (2024)

Agile ESO OTW PC 23mm (Boston Scientific) – Catheter Tip Detachment (2024)

Agile ESO OTW FC 23mm 10.1cm (Boston Scientific) – Catheter Tip Detachment (2024)

Agile ESO FC RMV 23mm 10.1cm (Boston Scientific) – Catheter Tip Detachment (2024)

Tablo Console (Outset Medical) – Blood Leak Sensor Sensitivity (2024)

WallFlex Esophageal FC 18/23-25mm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlex PC Esoph Stent 18/23mm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlex ESO Stent 23x105mm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlex ESO Stent LL 18x103 (Boston Scientific) – Catheter Tip Detachment (2024)

Agile ESO OTW PC 23mm 12.0cm (Boston Scientific) – Catheter Tip Detachment (2024)

Agile ESO OTW PC 23mm 15.0cm (Boston Scientific) – Catheter Tip Detachment (2024)

Silver-Plated Copper Sims Uterine Sound (CooperSurgical) – Incorrect Part Number (2024)

Inspire Model 4063 Stimulation Lead (Inspire) – Labeling Error (2024)

Stainless Steel Sims Uterine Sound (CooperSurgical) – Incorrect Part Number (2024)

MiniMed 630G (Medtronic) – Physical Impact Damage (2024)

MiniMed 670G (Medtronic) – Physical Impact Damage (2024)

MiniMed 620G (Medtronic) – Physical Impact Damage (2024)

Inspire Model 4340 Respiratory Sensing Lead (Inspire) – Labeling Error (2024)

IMMAGE IGM Immunoglobulin M Reagent (Beckman Coulter) – Sensitivity Issue (2024)