Injuries Caused by Recalled Medical Devices Lead to Claims

The Federal Drug Administration (FDA) regularly posts public summaries regarding serious medical device recalls. Medical devices that can cause serious injury or death are often placed on a recall list after the FDA becomes aware of dangers involving devises. The FDA categorizes the device recalls into Class I, II, and III recalls.

If you or a loved one has suffered an injury caused by a recalled medical device, you may be entitled to compensation. Contact the legal professionals Arnold & Smith, PLLC as soon as possible to schedule your free, initial consultation.

Companies produce medical devices to enrich our lives. Medical devices are designed with the intent to treat conditions that are difficult, if not impossible to treat. While our culture has seen astounding advances in innovative medical devices in recent years, many medical devices have failed. Some devices have been troubled by a defective design, while others have contained manufacturer defects.

When drug and medical device manufacturers fail to design or manufacture safe products, patients can become injured. Injured patients have a right to receive safe medical treatment. Unfortunately, many medical device companies have placed devices on the market before the devices have been adequately tested, or they have sold devices that contained obvious defects.

The FDA recalls products when the manufacturer takes a removal or correction action. A correction addresses a problem with a medical device in the place where the product is sold or used. A removal takes the medical device from the marketplace in which the product was sold or used. Sometimes, the FDA recalls products because the medical device needs to be fixed, adjusted, or checked.

Recalled medical devices that have been implanted in patients' bodies may or may not need to be removed. It is important to examine the reasons that a product was recalled. The FDA often notifies doctors and hospitals when a product has been recalled so that doctors can call patients and discuss the risks of leaving the device in place versus the risks associated with removing a device.

Numerous products have been subject to medical devices recalls in 2020, including the following:

• Arrow International Inc. recalled the Arrow AutoCAT®2 and AC3 Optimus® IABP Series products due to possible breakdown of motor connector wires;
• Medtronic recalled the StealthStation auto-registration feature due to inaccuracies during deep brain stimulation (DBS) procedures;
• Endologix Inc. recalled the Ovation iX Abdominal Stent Graft Systems due to risks of polymer leaks during implantation;
• Medtronic recalled HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief due to risk of breaks and tears during setup;
• Applied Medical recalled the Python Embolectomy, BARD Embolectomy, and OTW Latis Cleaning Catheters due to risk of separation during use;
• Vascular Solutions, Inc. recalled the Langston Dual Lumen Catheter due to the risk of separation during use;
• Boston Scientific Corporation recalled Imager II Angiographic Catheters due to tip detachment;
• LeMaitre Vascular Inc. recalled LeMaitre Over the Wire Embolectomy Catheter due to balloon deflation and separation issues;
• CME America recalled its BodyGuard Infusion Pump System due to the risk of over and under infusion;
• Medtronic recalled the Pipeline Flex Embolization device due to the risk of device fracture;
• CME America recalled the BodyGuard Microset Infusion Sets for the BodyGuard Infusion Pump System due to the risk of under-infusion;
• Becton Dickinson (BD) CareFusion 303 Inc. recalled its Alaris System Infusion Pumps due to software and system errors;
• King Systems recalled its King Vision Video Laryngoscope Adapter Size ½ due to a display showing the reversed image;
• Tytek Medical recalled the TM-317 PneumoDart-Pneumothorax Needle due to fully and partially blocked needles;
• Abbott Vascular recalled the NC Trek RX and NC Traveler RX Coronary Dilatation Catheters due to failure of the balloon (diameter 4.0mm, 4.5mm, and 5.00mm) to deflate;
• Teleflex Medical recalled the Comfort Flo Humidification Systems due to malfunction that may cause water to enter the airway;
• ResMed recalled the Stellar 100 and 150 Non-invasive and Invasive Ventilators due to a sound alarm failure;
• Medtronic recalled the MiniMed Insulin Pumps for incorrect insulin dosing;
• GE Healthcare recalled the Carestation 600 Series Anesthesia Systems due to loss of mechanical ventilation;
• GE Healthcare recalled the CARESCAPE Respiratory Modules due to incorrect oxygen values;
• Distributor Teleflex recalled the Galemed Babi Plus Pressure Relief Manifolds due to a dislodged valve.

If you have suffered an injury caused by a defective medical device, you may have a right to compensation. We advocate aggressively on behalf of clients in product liability lawsuits. Contact Arnold & Smith, PLLC as soon as possible to schedule your free initial consultation.