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Tornado Embolization Microcoil (Cook) – Sizing Error (2025)

Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.

FDAApr 17, 2025Nationwide• Cook Incorporated

Bard Blakemore Tube (C.R. Bard) – Plug Removal Issue (2025)

Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.

Moderate

FDAApr 17, 2025AL, AK, AZ +49 more• C.R. Bard Inc

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Tornado Embolization Microcoil (Cook) – Sizing Error (2025)

Bard Blakemore Tube (C.R. Bard) – Plug Removal Issue (2025)

Check=Flo Introducer (Cook) – Sizing Error (2025)

Verigene Blood Culture Test (Luminex) – Test Result Risk (2025)

ADVIA Centaur Calibrator (Siemens) – Reference Interval (2025)

Atellica Homocysteine Calibrator (Siemens) – Reference Interval (2025)

Straumann Initial Drill (Straumann) – Laser Engraving (2025)

VITROS Chemistry CRP Slides (Ortho-Clinical) – Labeling Error (2025)

Augmedics Perc Pin Adaptor (Augmedics) – Tightening Marking (2025)

Glidewell HT Implant Drill (Prismatik) – Packaging Mixup (2025)

Microtek Patient Drape (Microtek) – Sterility Concern (2025)

Centerline IOPS Guidewire (Centerline) – Coating Failure (2025)

iGo2 DC Car Adapter (Medical Depot) – Power Supply Risk (2025)

TufTex Embolectomy Catheter (LeMaitre) – Seal Integrity (2025)

Pruitt Irrigation Catheter (LeMaitre) – Seal Integrity (2025)

Pruitt Occlusion Catheter (LeMaitre) – Seal Integrity (2025)

Codman Craniotomy Kit (Integra) – Weld Integrity (2025)

Codman Disposable Perforator (Integra) – Weld Integrity (2025)

MedicaLyte Bicarbonate (Nipro) – Foreign Matter Risk (2025)

Blueprint Software (Tornier) – Case Access Issue (2025)