Recalls

A customer complaint investigation uncovered a potential problem with Edwards Lifesciences’ EMBOL-X Glide Protection System. It seems incidences of a bent tip may present a risk of breakage and subsequent embolization, so in the UK at least the company has issued a recall notice for certain batches.

Back in May, Stryker issued an Urgent Medical Device Recall requesting medical facilities to examine their inventory of five product … continue reading “FDA Class I Recall for Stryker Spine’s OASYS Midline Occiput Plate”

Cordis and the FDA have notified healthcare professionals and their organizations of a product labeling correction to provide clarification and additional information to minimize likelihood of implanting the company’s Optease Vena Cava filter backwards.

US device regulatory agency the FDA has issued a Class I recall, it’s highest category recall, for the LeMaitre Vascular Albograft Vascular graft, for the reason that it may leak from its surface following implantation. The same product was the subject of recall activity in Europe in March 2012, due to reports of profuse bleeding through the wall of the graft.

Australia’s regulatory authority, the Therapeutic Goods Administration (TGA) has issued a hazard alert pertaining to one of Medtronic’s pacing devices, the Consulta Cardiac Resynchronization Therapy Pacemaker (CRT-P). The action coincides with the company’s recall of certain Consulta and Syncra CRT-P devices.

On May 13, 2013, Endologix, Inc. initiated a recall of AFX Introducer System Model S17-45 due to reports of the dilator breaking during procedures. Now this recall has been elevated to FDA Class I status.

An FDA Class I recall has been issued because certain Symbios Pain pumps may have excessively high flow rates with the attendant risk that medications could be delivered too quickly from the balloon to the surgical site and cause patient toxicity.

Metal-on-metal hip problems are associated with J&J’s DePuy division with its infamous and ongoing ASR tribulations. Stryker isn’t without its … continue reading “Stryker ABG II Lawsuit Claim For $100M”

The UK’s regulatory agency, the MHRA has issued a device alert relating to reinforced endotracheal (ET) tubes manufactured by Convatec company Unomedical The device types are Murphy, Magill, Murphy with stylet and Magill with stylet.

The FDA has issued a Class I recall for the Cook Medical, Inc., Zilver PTX Drug-Eluting Peripheral Stent. All sizes, diameters and lot numbers manufactured prior to April 16 2013 are implicated.

The FDA has issued a Class I recall, it’s highest category, for Abbott Diabetes Care, FreeStyle InsuLinx Blood Glucose Meters. … continue reading “FDA Class 1 Recall For Abbott Diabetes Care’s FreeStyle InsuLinx Blood Glucose Meters”

Cook Medical’s aspirations with its Zilver® PTX® drug-eluting stent have been somewhat dented temporarily by the need to voluntarily recall the device following problems with its delivery device.

Four class I recalls in three days! It looks like someone at the FDA has been catching up with the paperwork as these four old recalls have been ramped up to Class I status in an attempt to put them to bed. One even goes back to 2011.

Covidien has voluntarily recalled certain Power Pac batteries for its Newport™ HT70 and HT70 Plus ventilators following customers reporting units alarming and switching to internal backup battery sooner than expected while the ventilator is being operated on Power Pac battery.

Stryker’s Shapematch cutting guide was the subject of a company recall last November. Now the FDA has upgraded the recall to Class I status, indicating the high risk it has placed on use of the device.

The FDA has issued a Class I recall notice relating to the Animas® 2020 Insulin Pump. It seems there are two problems with the device. A Class I recall notice, is the FDA’s most serious type of recall and reserved for cases where human health is at risk by continued use of the device.