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Vanta Clinician Programmer (Medtronic) – Communication Issue (2022)

Potential communication issue in which the Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 may be unable to connect with a Vanta Implantable Neurostimulator (INS) Model 977006 when a patient is implanted with more than one neurostimulator.

Moderate

FDAJul 26, 2022AL, AK, AZ +47 more• Medtronic Neuromodulation

Nobel Biocare N1 Implant (Nobel Biocare) – Aspiration Risk (2022)

Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.

High

FDAJul 25, 2022Nationwide• Nobel Biocare Vastra Hamngatan 1 Goteborg Sweden

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Vanta Clinician Programmer (Medtronic) – Communication Issue (2022)

Nobel Biocare N1 Implant (Nobel Biocare) – Aspiration Risk (2022)

NARMD Medical Depot Scissors (Stradis) – Sterile Barrier (2022)

NARMD Medical Depot Forceps (Stradis) – Sterile Barrier (2022)

HLS Set Advanced (Maquet) – Sterility Barrier (2022)

Baxter DISCPAC Syringe Caps (Baxter) – Packaging Sterility (2022)

HLS Set Advanced (Maquet) – Sterility Barrier (2022)

Corin MetaFix Hip Stem (Corin) – Incorrect Labeling (2022)

Medline Chest Tube (Medline) – Non-Sterile Component (2022)

Servo-Air Ventilator (Getinge) – Stability Issue (2022)

Autosoft 90 Cannula (Unomedical) – Insulin Fill Value (2022)

therascreen FGFR RGQ RT-PCR Kit (Qiagen) – False Positive Risk (2022)

NUCLISENS easyMAG Magnetic Silica (bioMerieux) – Contamination Potential (2022)

iSED Primary Pump Tubing (Alcor Scientific) – Biohazard Leak Risk (2022)

FGFR RGQ RT-PCR Kit (Qiagen) – False Positive Risk (2022)

Servo-u Ventilator System (Getinge) – Communication Failure (2022)

VITROS XT 3400 System (Ortho-Clinical) – Electrical Current Shift (2022)

NuVasive MD Pulse III System (NuVasive) – Remote Monitoring Failure (2022)

Roadrunner UniGlide Wire Guide (Cook) – Packaging Sterility Issue (2022)

Roadrunner PC Hydrophilic Wire Guide (Cook) – Packaging Sterility Issue (2022)