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Showing 5281–5300 of 68218 results

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Agile ESO OTW PC 23mm 10.1cm (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.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

Agile ESO OTW FC 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.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

Marodyne-LiV (BTT Health) – Power Supply Interruption (2024)

Some power supply units in Austria and Germany had a voltage drop in the millisecond range, which led to a cancellation of the treatment and subsequent restart of the medical device. The treatment is only restarted by a step-off/step-on (step-on for activation).

Low

FDAAug 1, 2024Nationwide• Btt Health Gmbh Billerberg 7 Inning Germany

WallFlex ESO Stent LL 23x105 (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.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

WallFlex Esophageal FC 23/28mm (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.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

WallFlex ESO Stent 18x103mm (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.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

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).

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.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

Agile ESO OTW PC 23mm (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.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

Agile ESO OTW FC 23mm 10.1cm (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.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

Agile ESO FC RMV 23mm 10.1cm (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.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

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

Blood leak sensor, a component of hemodialysis device, may show decreased sensitivity, at the lowest level, specified as 0.35 mL/min blood leak rate, which could delay triggering the ALARM_DIALYZER_BLOOD_LEAK alarm, if blood loss, less-than 300ml, occurs, the patient may experience hypotension, fatigue, cramps, dizziness, headaches, nausea, and shortness of breath.

FDAAug 1, 2024AL, AK, AZ +43 more• Outset Medical, Inc.

WallFlex Esophageal FC 18/23-25mm (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.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

WallFlex PC Esoph Stent 18/23mm (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.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

WallFlex ESO Stent 23x105mm (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.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

Bikano Moong Dal (Thal Golden Spices) – salmonella risk (2024)

Potential Salmonella contamination.

FDAAug 1, 2024CA, IN• Thal Golden Spices Inc.

Methotrexate Tablets (Amneal) – Foreign Tablet Contamination (2024)

Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.

FDAAug 1, 2024Nationwide• Amneal Pharmaceuticals, LLC

Heparin Sodium Injection (Baxter) – Endotoxin Contamination (2024)

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

FDAAug 1, 2024Nationwide• Baxter Healthcare Corporation

J-Basket Napa Kimchi (JFC International) – yeast growth (2024)

High levels of Yeast growth and film on top of jarred Kimchi product.

Class IIModerate

FDAAug 1, 2024AZ, CO, FL +7 more• J F C International Inc

WallFlex ESO Stent LL 18x103 (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.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

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