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DuraMax Stacked Tip Vasc-Pak (Angiodynamics) – Metal Shavings Risk (2024)

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

High

FDAMar 18, 2024VA• Angiodynamics, Inc.

DuraMax Stacked Tip 28cm Kit (Angiodynamics) – Metal Shavings Risk (2024)

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

High

FDAMar 18, 2024VA• Angiodynamics, Inc.

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DuraMax Stacked Tip Vasc-Pak (Angiodynamics) – Metal Shavings Risk (2024)

DuraMax Stacked Tip 28cm Kit (Angiodynamics) – Metal Shavings Risk (2024)

DuraMax Stacked Tip Kit (Angiodynamics) – Metal Shavings Risk (2024)

DuraMax Stacked Tip 24cm Kit (Angiodynamics) – Metal Shavings Risk (2024)

Innova IGS 5 X-Ray System (GE) – Bolt Adhesive Potential Issue (2024)

DuraFlow 2 28cm Kit (Angiodynamics) – Metal Shavings Risk (2024)

DuraFlow 2 24cm Kit (Angiodynamics) – Metal Shavings Risk (2024)

DuraFlow 2 55cm Kit (Angiodynamics) – Metal Shavings Risk (2024)

DuraFlow 2 24cm Vasc-Pak (Angiodynamics) – Metal Shavings Risk (2024)

BioFlo DuraMax Sheath Kit (Angiodynamics) – Metal Shavings Risk (2024)

DuraMax Stacked Tip Vasc-Pak (Angiodynamics) – Metal Shavings Risk (2024)

DuraMax Stacked Tip Vasc-Pak (Angiodynamics) – Unspecified Issue (2024)

Allia IGS 7 OR X-Ray System (GE) – Bolt Adhesive Potential Issue (2024)

DuraFlow 2 28cm Vasc-Pak (Angiodynamics) – Metal Shavings Risk (2024)

Allia IGS 5 Pulse X-Ray System (GE) – Bolt Adhesive Potential Issue (2024)

Interact Discovery RT X-Ray System (GE) – Bolt Adhesive Potential Issue (2024)

Allia IGS 7 X-Ray System (GE) – Bolt Adhesive Potential Issue (2024)

LightStrike Blackout Curtains (Xenex) – UV Protection Limitation (2024)

Innova IGS 6 X-Ray System (GE) – Bolt Adhesive Potential Issue (2024)

Alcon Custom Paks Surgical Procedure Pack (Alcon) – Sterile Cannula Issues (2024)