News | March 27, 2013

Vascular Solutions Recalls Guardian II Hemostasis Valves

Class I recall due to risk of air being introduced into device

Guardian II Hemostais Valve, recall

March 27, 2013 — The U.S. Food and Drug Administration (FDA) notified healthcare professionals of a Class I recall of the Vascular Solutions Inc. Guardian II and Guardian II NC Hemostasis Valves, model numbers 8210, 8211, 8215 and 8216. The firm is recalling the product due to a risk that air may be introduced into the device, which may lead to an air embolism. This product may cause serious adverse health consequences, including death.

A list of the recalled lot numbers is available from Vascular Solutions and has been provided to each facility that purchased the affected products. The recalled products were manufactured and distributed from February 2012 to February 2013.

The Guardian II and Guardian II NC hemostasis valves are intended to reduce blood loss during catheterization procedures.

On Feb. 28, 2013, Vascular Solutions sent an urgent medical device recall letter to its customers. The letter described the problem and the product involved in the recall. The firm advised its customers to immediately remove the recalled product from their inventory and secure it.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

For more information: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm345520.htm

 

 

Related Content

Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Mississippi Surgical and Vascular Center Uses Toshiba Ultimax-i FPD to Save Patients' Limbs
News | Angiography| September 14, 2017
The southern U.S. sees some of the highest numbers of chronic medical conditions, such as peripheral artery disease...
Sponsored Content | Videos | Structural Heart Occluders| September 13, 2017
Ziyad Hijazi, M.D., MPH, MSCAI, FACC, director of the cardiac program and chair of the Department of Pediatrics at Si
Philips Showcases Integrated Vascular Solutions at VIVA 2017
News | Peripheral Artery Disease (PAD)| September 13, 2017
Philips announced its presence at the Vascular Interventional Advances (VIVA 17) Annual Conference in Las Vegas from...
Medtronic Announces Japanese Regulatory Approval for In.Pact Admiral Drug-Coated Balloon
News | Drug-Eluting Balloons| September 13, 2017
Medtronic plc announced that the In.Pact Admiral Drug-Coated Balloon (DCB) received approval from the Japanese Ministry...
PQ Bypass Reports Positive Results for Detour System in Patients With Long Femoropopliteal Blockages
News | Peripheral Artery Disease (PAD)| September 13, 2017
A subset analysis of the DETOUR I clinical trial showed promising safety and effectiveness results of PQ Bypass’ Detour...
Overlay Init