Biosense Webster, Inc. recalls VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac…
Due to an observed trend of neurovascular events
Read the official notice →- Date
- 2025-03-12
- Country
- United States
- Brand
- Biosense Webster
- Product
- VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac…
- Classification
- Class I
- Units
- Worldwide distribution; US states of AR, CA, CO, KS, LA, MA, MO, NY, OH and…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
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- 2024-03-20
USBiosense Webster, Inc. recalls CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide…
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FDA · DeviceBiosense Webster, Inc.U.S. Nationwide distribution including in the states of FL, IL, AL, NY, PA,…Official notice →- 2023-04-12
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FDA · DeviceBiosense Webster, Inc.Worldwide distribution - US Nationwide distribution including the states of…Official notice → - 2022-09-14
- US
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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…
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Other drugs & medical recalls in the United States
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Safecor Health, LLC recalls Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mfg by: Westminster,…
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
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