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medical device recall -

Leakage Threat Prompts Tandem To Recall Insulin Cartridges

By Los Angeles Personal Injury Lawyer on January 16, 2014

Insulin users should be aware of a recent recall affecting a product used for the administration of the substance.  The recall, which was issued by Tandem Diabetes Care, affects those cartridges that are supposed to be used in connection with the t:slim Insulin Pump.  47,460 cartridges, ten to a box, are being recalled because of the possibility of a leakage.  When this occurs, the person receiving insulin could receive an incorrect amount, causing health issues if they don’t get enough insulin or if they get more than is suggested.  The items, which were made available after December 17 of this past year, ought not to be used.  Replacement cartridges can be obtained from the company.

Click here for more about the recall.

TorFlex Transseptal Guiding Sheath Kits Recalled Over Injury Risk

By Los Angeles Personal Injury Lawyer on November 7, 2013

TorFlex Transseptal Guiding Sheath Kits are being recalled by Baylis Medical because of a potential patient injury hazard.  These devices, which are composed of a dilator, a guidewire, and a sheath, are supposed to allow for a medical professional to conduct a heart chamber catheterization and an angiography.  It’s the sheath and the dilator that reportedly pose the defect, as a particulate smaller than five millimeters in size could apparently be dislodged from the dilator by the sheath.  When that happens, said particulate could make its way into the individual’s bloodstream, which poses an injury risk to that patient.  These products should be quarantined by medical professionals as soon as possible, and any instances of adversity ought to be reported to the company and to MedWatch.

Click here for more about the recall.

Injury Risk Prompts Recall of LifeStent Solo Vascular Stents

By Los Angeles Personal Injury Lawyer on October 22, 2013

LifeStent Solo Vascular Stents are being recalled by Bard Peripheral Vascular due to a potential injury and fatality hazard posed by the products.  When a person experiences lesions attributed to blood vessel constriction, he or she may receive this particular stent as a means to open the space within the blood vessel.  Unfortunately, it has been discovered that the products may not be able to deploy once inserted or they could only be deployed partially.  When this happens, an individual could face blood loss, a stroke, or a heart attack.  It’s also possible that the patient could lose a limb or even die.  Recall instructions reportedly started to go out to affected parties at the end of last month.

For more about the recall, click here.

Failure Risk Prompts Recall of Samaritan 300/300P Defibrillators

By Los Angeles Personal Injury Lawyer on September 17, 2013

Samaritan 300/300P PAD public access defibrillators are being recalled by HeartSine technologies due to a possible failure issue that could lead to a delay in a person getting needed therapy for cardiac arreast.  The issues associated with the devices are twofold:  first, the items can randomly turn on and off, a condition that may deplete the battery, and second, some defibrillators may turn off because an early version of the software thinks a battery is low when in fact there has simply been a drop in voltage.  The defibrillators were produced and made available around the world between August 2004 and December 2010.  Owners are being asked to check that the devices are working and to get in touch with HeartSine for a new product or an upgrade kit.

Click here for more about the recall.

OASYS Midline Occiput Plate Spinal Implants Recalled Over Injury Risk

By Los Angeles Personal Injury Lawyer on August 30, 2013

Stryker has announced the recall of the OASYS Midline Occiput plate spinal implant due to concerns about the possibility of patient adversity.  The pin that keeps the plate body and the tulip head of the devices connected is apparently in danger of suffering a fracture.  When this occurs, it can do damage to the patient’s nerves and cause them to lose blood.  Patients would also potentially have to submit to a revision surgery in order to get a new implant that doesn’t suffer from the issue.  Medical professionals are being asked to cease providing affected products to patients, while those surgeons who know they’ve already implanted the items are being asked to monitor patients for adversity.  Any reports of pain or weakness should prompt an immediate check-up.

For more about the recall, follow this link.

LPS Lower Extremity Dovetail Device Recalled By DePuy Over Safety Risk

By Los Angeles Personal Injury Lawyer on August 2, 2013

DePuy Orthopaedics has announced the recall of LPS Lower Extremity Dovetail Intercalary Components because of an issue that could lead to pain or even a revision procedure.  The device, which is implanted in patients requiring a partial or total femur replacement or a proximal tibia replacement, can experience a fracture along the female portion of the device.  It reportedly does not take extensive activity and pressure for this to occur; the fracture can take place even during simple walking.  When it happens, the user can experience intense pain, lost limb function, an infection, and more, and the failure may necessitate a revision surgery.  Surgeons are being asked to cease implanting the device and doctors are being asked to speak with patients who have gotten the devices implanted.

Click here for more about the recall.

V60 Ventilators Recalled By Respironics California Over Injury Risk

By Los Angeles Personal Injury Lawyer on June 21, 2013

V60 ventilators are being recalled by Respironics California because of a potential software issue that could compromise patient safety.  The items were made available across the country between November 16, 2009 and March 28 of this year.  The Power Management Board Assembly, if it experiences a component failure, may lead to support being taken away from the ventilator, causing the product not to work.  There is also a chance that an alert would not be issued when this happens.  These circumstances could lead to a serious injury or a fatality.  Owners are being told to keep using the product and to await an upcoming software update.  An update and product replacement will be provided to affected individuals.

Click here for more about the recall.

GOBlock and GoPump Kits Recalled By Symbios Over Safety Threat

By Los Angeles Personal Injury Lawyer on May 17, 2013

GOBlock Kits and GoPump Rapid Recovery System kits are being recalled by Symbios Medical Products because of an issue that could compromise patient safety.  Versions of the items that have flow controls put together before July of last year could suffer from flow rates that exceed what would be considered safe.  This could lead to heightened levels of medications being administered to the patient, and thus he or she would be susceptible to toxicity and the associated threat of seizures or even a fatality.  Five incidents have been reported, two of them serious.  It has been noted that no fatalities have reportedly occurred thus far.  Symbios is getting in touch with all affected parties.

For more about the recall, follow this link.

Presource Kits Recalled By Cardinal Health Over Airflow Blockage Risk

By Los Angeles Personal Injury Lawyer on May 7, 2013

Presource Kits with a Filter and Anesthesia Circuit that has already been put together prior to distribution are being recalled by Cardinal Health.  Because this component has been assembled already, persons who remove the outer plastic without first taking apart the component could find pieces of plastic wound up stuck in the filter.  As the product is used to deliver oxygen or nitrous oxide to a patient undergoing various types of operations, a blockage of the filter could lead to the patient’s air supply being compromised.  This can lead to serious dangers, including a fatality.  Those with this item in their possession are being provided with a warning label that should be affixed at once.  Adversity should be reported to MedWatch.

For more about the recall, click here.

Zilver PTX Peripheral Stents Recalled By Cook Over Patient Risk

By Los Angeles Personal Injury Lawyer on April 25, 2013

Zilver PTX Drug Eluting Peripheral Stents are being recalled by Cook Medical because of an issue with the catheters that could potentially compromise patient safety.  The products’ delivery system could become dislodged from the inner catheter’s tip, a condition which could cause a host of health complications.  This possible adversity includes cardiac arrest, thrombosis, vascular occlusion.  Surgery might be required to take the broken tip out of the patient, and in some cases, amputation might be necessary.  13 instances of separation have been reported at this point, one of which led to a fatality and two of which caused some adversity.  The products were provided to medical facilities across the country between December 13 and April 16.  The devices should be quarantined and sent back to the company.

Follow this link for more about the recall.

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