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…
Read the official notice →- Date
- 2022-09-14
- Country
- United States
- Brand
- Biosense Webster
- Product
- CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.
- Classification
- Class II
- Units
- US Nationwide distribution in the states of AL, GA, AZ, TX, MA, VA, NY, ME,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
USBiosense 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
FDA · DeviceBiosense Webster, Inc.Worldwide distribution; US states of AR, CA, CO, KS, LA, MA, MO, NY, OH and…Official notice →- 2024-03-20
- US
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.
FDA · DeviceBiosense Webster, Inc.U.S. Nationwide distribution including in the states of FL, IL, AL, NY, PA,…Official notice → - 2023-04-12
- US
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 →
Other drugs & medical recalls in the United States
- 2022-09-14
- US
BALT USA, LLC recalls Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.
- US
Abbott Molecular, Inc. recalls Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic…
Reports received of an increase of message code 9186 (internal control failed) when using the kit.
FDA · DeviceAbbott Molecular, Inc.Distribution was made to AZ, CA, CT, FL, GA, IL, KS, KY, LA, MA, MI, MN, MO,…Official notice → - US
OrthoPediatrics Corp recalls Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which could result in a delay of…
FDA · DeviceOrthoPediatrics CorpUS Nationwide Distribution: AZ, AL, CA, FL, FL, MD, MO, NC, NY, TX Foreign:…Official notice → - US
Ortho-Clinical Diagnostics, Inc. recalls VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer.…
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
- US
Philips Respironics, Inc. recalls Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and…
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
FDA · DevicePhilips Respironics, Inc.Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA,…Official notice →