medical device recall -

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 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 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.

LifeScan has announced the recall of OneTouch Verio IQ Meters because of an issue that could compromise safety.  When a person has blood glucose levels above 1024 mg/dL, an amount that would be potentially dangerous to patients, a message explaining that Glucose is extremely high (i.e. higher than 600 mg/dL) is supposed to pop up.  On these units, though, the incredibly high level actually prompts a system shutoff.  Once turned back on, the device then goes to Set Up mode, but if it’s still measuring the severely high glucose levels, it will simply turn off anew.  If you experience these circumstances, get in touch with a doctor at once.  The recall affects all versions of the product.  They were made available between December 2011 and this past March.

For more about the recall, click here.

Giraffe Omnibeds and Giraffe Incubators that utilize a Servo Control Oxygen System have been recalled by GE Healthcare because of a possible threat to patient safety.  The recall was actually issued toward the beginning of the year, but GE is issuing this latest announcement as a means to confirm that affected owners have been properly notified and to relate the fact that inspections should be carried out shortly by a GE engineer.  When the items are powered on, whether after a power failure or otherwise, the radiant heater and oxygen set point manual settings can revert to pre-input levels.  This could imperil the safety of patients requiring specific parameters.

For more about the recall, follow this link.

Power Pac batteries have been recalled by Covidien because of an issue that could compromise patient safety when the units are used in conjunction with the HT70 and HT70 Plus Ventilators from Newport.  There are two safety issues of note:  when the ventilators are taken off of AC power, the backup battery source might kick in at once, and secondly, the unit might mistakenly show that the Power Pac battery is charged when that isn’t the case.  Either situation prompts the internal backup battery to offer support for 30 minutes, but a hazard might occur when an alternate power system can’t be found within that timeframe; for instance, when a patient is in transit.  No injuries have been reported thus far, and those with affected units should get in touch with Newport Medical to obtain free batteries.

Click here to learn more about the recall.

Freestyle Insulinx Blood Glucose Meters have been recalled by Abbott because there’s a possibility that they wouldn’t display the correct glucose reading in persons who may need prompt medical attention.  The issue takes place when a person’s blood glucose is higher than 1024 mg/dL.  The meter will potentially subtract 1024 mg/dL from the actual glucose level and display that information, severely underestimating the heightened level of glucose in the patient’s blood.  The person might not know that they should seek out medical help at once, and they could thus face a serious injury or even a fatality.  One incident in which the patient received hyperglycemia treatment and was released has been reported, but it may or may not be related to the issue.  Customers can get a replacement unit or update the software at no cost.

Click here for more about the recall.

This past January, the Stryker Corporation announced the recall of ShapeMatch Cutting Guides typically used during knee replacement surgery.  The company worried that the products may have been produced in a manner not in line with approved procedural methods or in the parameters laid out in surgical preoperative planning.  At the time, surgeons were told that, although they were to bring the items back, meeting with the patient in a manner that went further than routine care was not required.  Now, though, the company is explaining that the recall has been designated as Class I by the Food and Drug Administration.  This is the most serious form of recall there is.  Patients who experience a problem with their ShapeMatch Cutting Guide could find their knee replacements not working as they should.

To learn more about this recall, click here.

A series of medical devices that are designed to alert caregivers to a potential problem are being recalled because there’s a possibility that the alarm sounds would not be emitted properly.  Smiths Medical announced the recall, which affects BCI Remote Alarm Cables used in conjunction with the 9004 Canocheck Capnography System.  The device is used to move the alarm signal from that system to a remote alarm.  The system is typically put in place during patient transport, ventilation, anesthetic distribution, and more.  Unfortunately, there’s a chance that the alarm isn’t properly transferred, which might lead to a treatment delay that causes adversity.  The affected items should not be used, and medical professionals have been asked to get in touch with MedWatch in cases where the defect has made itself known.

For more about the recall, click here.

It’s been a few weeks since a Los Angeles jury awarded a plaintiff $8.3 million for the ordeal he was put through after being implanted with the DePuy ASR metal on metal hip implant, a device which later failed. Thousands of people have filed similar lawsuits, and one of those is currently underway in Chicago.

Like the Los Angeles trial before it, the proceedings have the potential to be quite revealing.  Already, a former employee with DePuy has testified via video about an email he says outlined the thinking that design flaws with the all-metal implant were to blame for the heightened failure rates and problems with the device.

Said email is purported to have been sent by a marketing vice president at the company.  Dated March 2009, the email explained that the design of the device was problematic.  The testifying employee explained that this led him to think that the eventual recall was issued because of the exorbitant amount of revisions that were required because of a failure of the device.

This is contrary to the thinking expressed by Johnson & Johnson and Depuy, who have long claimed that design flaws were not the culprit for the recall.  Still, one can’t deny the 93,000-unit recall in 2010, or the estimated 40%-plus revision rate reported in Australia within seven years of implantation.