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Titan Touch NB Prosthesis (Coloplast) – Pump Failure Risk (2023)

A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.

High

FDAMar 1, 2023Nationwide• Coloplast Manufacturing US, LLC

Titan NB Prosthesis (Coloplast) – Pump Failure Risk (2023)

High

FDAMar 1, 2023Nationwide• Coloplast Manufacturing US, LLC

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Titan Touch NB Prosthesis (Coloplast) – Pump Failure Risk (2023)

Titan NB Prosthesis (Coloplast) – Pump Failure Risk (2023)

Leksell Stereotactic System Manuals (Elekta) – Incorrect IFU (2023)

CAPIOX FX25 Oxygenator (Terumo) – Thermistor Bonding (2023)

Titan Pump Assembly (Coloplast) – Pump Failure Risk (2023)

Trilogy EV300 Ventilator (Philips Respironics) – Oxygen Accuracy (2023)

Trilogy Evo O2 Ventilator (Philips Respironics) – Oxygen Accuracy (2023)

Color Cuff Tourniquet (Stryker) – Pressure Failure (2023)

Express Mini 500 Chest Drain (Atrium) – Insufficient Instructions (2023)

Trilogy Evo Universal Ventilator (Philips Respironics) – Oxygen Accuracy (2023)

Chromic Gut Sutures (Unknown) – Sterilization Issue (2023)

Step Bladeless Trocars (Unknown) – Sterilization Problem (2023)

United Imaging PET System (Shanghai United Imaging) – Scatter Correction Failure (2023)

Titan NB Prosthesis (Coloplast) – Pump Failure Risk (2023)

Titan Touch Prosthesis (Coloplast) – Pump Failure Risk (2023)

Titan 0-Deg Prosthesis (Coloplast) – Pump Failure Risk (2023)

Plain Gut Absorbable Sutures (Unknown) – Sterilization Issue (2023)

Titan Touch NB Prosthesis (Coloplast) – Pump Failure Risk (2023)

Bard Mission Biopsy Instrument Kit (Bard) - Size Mismatch (2023)

Monaco RTP System (Elekta) - Dose Presentation Error (2023)