Synthes USA is recalling all lots of the Ti Synex II Vertebral Body Replacement device. The U.S. Food & Drug Administration (FDA) has deemed the Synthes USA Ti Synex II Vertebral Body Replacement recall a Class I recall.

The Ti Synex II Vertebral Body Replacement is used in the T1-L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body. The recall is being issued because of reports of moderate to severe loss of vertebral body replacement height (caused by failure of the central body component) in situ occurring at six to fifteen months post implantation. (more…)

Edwards Lifesciences Corporation has issued a recall of CardioVations EndoClamp Aortic Catheter. The Food & Drug Administration (FDA) has deemed this a Class I recall, its most serious type of recall.

The CardioVations EndoClamp Aortic Catheter locks off the aorta, monitors aortic pressure, and delivers solution to stop the heart during cardiopulmonary bypass procedures. According to the recall notice, the balloon catheters may spontaneously rupture during surgery. (more…)

Cordis Corporation is recalling all lots of the Crossover Sheath Introducer due to complaints about stretching or fracture of the sheath during use.

To date, Cordis has received six complaints about the Crossover Sheath Introducer. No permanent patient injuries have been reported. In two instances, successful surgical intervention was performed to retrieve a portion of the sheath. (more…)

A voluntary nationwide recall was issued yesterday for all Accusure® Insulin Syringes manufactured by Qualitest Pharmaceuticals of Huntsville, Alabama.

The recalled syringes may have needles which detach from the syringe. According to the recall notice, if the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into to the syringe, or remain in the skin after injection. (more…)

Certain units of the single-patient use Manual Pulmonary Resuscitator (MPR) have been recalled by Unomedical Inc. This recall is being conducted because of a potential malfunction of the MPR, which may impair the ability of the device to generate the positive pressure necessary to function properly. The occurrence of such a malfunction may create a situation in which the use of the product could potentially cause serious adverse health consequences or death.

Pulmonary resuscitators are used to administer artificial respiration to a patient while also giving an external cardiac massage. They are used during CPR to resuscitate patients suffering from cardiac arrest, and resuscitators use positive pressure to inflate the lungs of the patient while they are not breathing, in order to keep them oxygenated. (more…)

Accu-Check Spirit insulin pumps are being recalled by Disetronic Medical Systems Inc., a unit of the Roche Group, because of a potential defect in the “up” and/or “down” buttons of some devices. According to the recall notice, if the buttons do not function, users may not be able to change any programmed setting on the Accu-Check Spirit insulin pumps.

“We are making this proactive notification to our customers and other interested parties because we have seen a potential for the “up” and/or “down” buttons on some of our pumps to fail over a period of use,” Dr. Mathias Neumann, Head of Global Quality Management Diabetes Care, Roche Diagnostics, said in a statement released by the company. “We are telling our customers to continue to use their ACCU-CHEK Spirit insulin pumps, but monitor the functioning of the “up” and “down” buttons. In addition customers are to continue to monitor their blood glucose as directed by their healthcare professional.” (more…)

A class I recall has been issued for Medtronic BioGlide Ventricular Shunt Catheters. A class I recall is issued when a device poses a risk of serious injury and death.

The recalled Medtronic BioGlide Ventricular Shunt Catheter is part of a system used to treat a condition called hydrocephalus, which is characterized by an excessive accumulation of fluid in the brain. While hydrocephalus occurs in adults, it is most common in children. (more…)

A simple medical device called the Calaxo Bone Screw has been causing a great deal of pain and suffering for those who have undergone Anterior Cruciate Ligament (ACL) reconstructive surgery. The Calaxo Bone Screw was recalled in August 2007 due to reports of serious complications. Some patients even had to have repeat surgeries to have the Calaxo Bone screw replaced.

The ACL, which runs from the tibia, or shin bone, through the knee joint and to the femur or thigh bone, helps stabilize the knee and control front-to-back movement. ACL tears are most frequent among athletes who participate in sports such as soccer or skiing that require them to jump or change direction quickly and frequently. (more…)

Welch Allyn has issued a worldwide recall of various AED 10 and MRL JumpStart automatic external defibrillators manufactured between October 3, 2002 and January 25, 2007. The Food & Drug Administration (FDA) has deemed the Welch Allyn defibrillator recall a Class I recall because there is a reasonable probability that use of the product will cause serious injury or death.

According to the FDA, the recalled Welch Allyn defibrillators are used by emergency or medical personnel, or by others who have completed CPR AED training courses. The devices are intended to treat adults who are having a heart attack. The device analyzes an unconscious patient’s heart rhythm and automatically delivers an electrical shock to the heart if needed to restore a normal heart rhythm. (more…)

Covidien Inc. is recalling several lots of Shiley 3.0PED Cuffless Pediatric Tracheostomy Tubes because practitioners have reported difficulty inserting two of the device’s components during procedures. The action has been deemed a Class I recall, the Food & Drug Administration’s (FDA) most urgent type of recall. Class I recalls are issued when there is a reasonable probability that use of a product will cause serious injury or death.

The Covidien Pediatric Tracheostomy Tube recall involves the following lot numbers: 0806000266, 0806000858, 0806000859, 0806001328, 0807000555, 0807001444, 0807002502, 0808000387, 0808000431, 0808002285, 0810000288, 0810000289, 0810000864, 0810000865, 0810001201, 0811000228, 0811000522, 0811000523, 0811000546, 0811000547, 0811001875. (more…)