Biosense Webster, Inc. recalls CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide…
Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.
Read the official notice →- Date
- 2024-03-20
- Country
- United States
- Brand
- Biosense Webster
- Product
- CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide…
- Classification
- Class II
- Units
- U.S. Nationwide distribution including in the states of FL, IL, AL, NY, PA,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Biosense Webster recalls
- 2025-03-12
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FDA · DeviceBiosense Webster, Inc.Worldwide distribution; US states of AR, CA, CO, KS, LA, MA, MO, NY, OH and…Official notice →- 2023-04-12
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Biosense Webster, Inc. recalls Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch
FDA · DeviceBiosense Webster, Inc.Worldwide distribution - US Nationwide distribution including the states of…Official notice → - 2022-09-14
- US
Biosense Webster, Inc. recalls CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.
Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the sterile barrier of the product inside. Devices with a compromised…
FDA · DeviceBiosense Webster, Inc.US Nationwide distribution in the states of AL, GA, AZ, TX, MA, VA, NY, ME,…Official notice →
Other drugs & medical recalls in the United States
- 2024-03-20
- US
Retractable Technologies, Inc. recalls EasyPoint Needle, 25G x 5/8", REF: 82091
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SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION recalls Shimadzu, Trinias, Digital Angiography System
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Baxter Healthcare Corporation recalls CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401
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Baxter Healthcare Corporation recalls STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
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Peter Lazic Gmbh recalls L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Sterile
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Medos International Sarl recalls CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use
Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury and in extreme rare occasions it may…