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Showing 7701–7720 of 35916 results

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Left Heart Vent Catheters (Medtronic) – Sterile Packing Issue (2024)

Potential for unsealed sterile packing.

Moderate

FDAMar 19, 2024Nationwide• Medtronic Perfusion Systems

Suction Tubes (Medtronic) – Sterile Packing Issue (2024)

Potential for unsealed sterile packing.

Moderate

FDAMar 19, 2024Nationwide• Medtronic Perfusion Systems

Disposable Pressure Display Sets (Medtronic) – Sterile Packing Issue (2024)

Potential for unsealed sterile packing.

Moderate

FDAMar 19, 2024Nationwide• Medtronic Perfusion Systems

DuraFlow 2 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.

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.

DuraMax Stacked Tip 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.

DuraMax Stacked Tip 24cm 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.

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

GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.

High

FDAMar 18, 2024Nationwide• GE Medical Systems, SCS

DuraFlow 2 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.

DuraFlow 2 24cm 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.

DuraFlow 2 55cm 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.

DuraFlow 2 24cm 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.

BioFlo DuraMax Sheath 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.

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 Vasc-Pak (Angiodynamics) – Unspecified Issue (2024)

XXX

High

FDAMar 18, 2024VA• Angiodynamics, Inc.

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

High

FDAMar 18, 2024Nationwide• GE Medical Systems, SCS

DuraFlow 2 28cm 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.

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

High

FDAMar 18, 2024Nationwide• GE Medical Systems, SCS

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

High

FDAMar 18, 2024Nationwide• GE Medical Systems, SCS

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