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Boston Scientific POLARx Balloon Catheter (Boston Scientific) – Use Instructions (2024)

Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

FDAOct 10, 2024Nationwide• Boston Scientific Corporation

BioZorb Marker (Hologic) – Adverse Event Risk (2024)

Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.

FDAOct 10, 2024Nationwide• Hologic, Inc

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Boston Scientific POLARx Balloon Catheter (Boston Scientific) – Use Instructions (2024)

BioZorb Marker (Hologic) – Adverse Event Risk (2024)

Boston Scientific POLARx Balloon Catheter (Boston Scientific) – Use Instructions (2024)

Cinacalcet Tablets 90mg (Accord) – Nitrosamine Impurity (2024)

Cinacalcet Tablets 60mg (Accord) – Nitrosamine Impurity (2024)

Cinacalcet Tablets 30mg (Accord) – Nitrosamine Impurity (2024)

Vygon 100mL EVA Container (Metrix) – IV Bag Leak (2024)

Cormix 150mL EVA Container (Metrix) – IV Bag Leak (2024)

SECURE 50 mL EVA Container (The Metrix Company) – IV Bag Leak Risk (2024)

SECURE 100 mL EVA Container (The Metrix Company) – IV Bag Leak Risk (2024)

Imed Products Imed EVA Bag 250 mL (The Metrix Company) – IV Bag Leak Risk (2024)

SECURE 1000 mL EVA Container (The Metrix Company) – IV Bag Leak Risk (2024)

MEDLINE Convenience Kits (MEDLINE) – Smoke Evacuation Pencil Issue (2024)

MEDLINE Medical Convenience Kits (MEDLINE) – Smoke Evacuation Pencil Issue (2024)

Autosampler SIL-40C Models (Unknown) – Main Board Condensation Failure (2024)

Imed Products Imed EVA Bag 500 mL (The Metrix Company) – IV Bag Leak Risk (2024)

Autosampler SIL-20/30 Models (Unknown) – Main Board Condensation Failure (2024)

SECURE 250 mL EVA Container (The Metrix Company) – IV Bag Leak Risk (2024)

Imed Products Imed EVA Bag 150 mL (The Metrix Company) – IV Bag Leak Risk (2024)

SECURE 500 mL EVA Container (The Metrix Company) – IV Bag Leak Risk (2024)