Thousands of Tracheostomy Tubes Intended for Children and Babies Recalled

Thousands of Tracheostomy Tubes for Children Recalled

Thousands of Tracheostomy Tubes for Children Recalled


Medtronic has recalled 70,000 of its Covidien Shiley tracheostomy tubes for children and babies after receiving reports that some patients had difficulty breathing with them.

In 2012, Medtronic altered its Covidien Shiley tracheostomy tubes to give it a wider angle. Since that time, regulators have received hundreds of adverse event reports concerning the device. In a statement issued on Tuesday that was obtained by StarTribune, Medtronic said that switching back to models predating the design change seemed to address the young patients’ breathing issues. [Read more…]

The Fortune 500 Drops Medtronic From the List After the Company Sets up its Headquarters in Ireland

Fortune 500 Drops Medtronic From the List

Fortune 500 Drops Medtronic From the List


Medtronic’s move to Ireland has prompted Fortune to kick the company off of its Fortune 500 list. The company would have been number 185 on the list.

The company was acquired by Dublin, Ireland-based medical device maker Covidien for $42.9 million, but continues to operate its headquarters in Minneapolis, Minnesota. Under current law, U.S corporations pay taxes to whichever nation its domicile resides in, but companies can easily bring those profits back to the U.S. without them being taxed at higher rates, according to MinnPost. Medtronic CEO Omar Ishrak told the Financial Times in June of last year that this was the company’s goal. [Read more…]

Lawsuit Filed Against Medtronic Over Its InFuse Bone Graft Product

Lawsuit Filed Against Medtronic

Lawsuit Filed Against Medtronic


A lawsuit has been filed against Medtronic, Inc. on behalf of numerous patients who allege product liability, fraud, and injuries that include catastrophic, unchecked bone growth in the spinal column following surgical procedures with InFuse.

Court documents allege product liability and fraud over Medtronic’s InFuse Bone Graft LT-Cage Lumbar Tapered Fusion Device System. The suit was filed by Parker Waichman LLP, Neblett Beard & Arsenault, The Drakulich Firm, The Holland Law Firm, and The Lanier Law Firm. InFuse received limited Food and Drug Administration (FDA) approval for use in a single level fusion. Infuse is a genetically engineered, synthetic, recombinant human bone morphogenetic protein (rhBMP-2) that received FDA approval to stimulate spine growth in patients suffering from lower spinal degenerative disease; for use in one type of spinal surgery; and for use in some dental procedures. Infuse is not approved for use on the upper (cervical) spine though it has been widely used in such procedures. [Read more…]

Medtronic, Inc. Hit with a Consent Decree for Repeatedly Failing to Correct Manufacturing Problems with its Synchromed II Implantable Infusion Pump Systems

Medtronic, Inc. Hit with a Consent Decree for Pump Systems

Medtronic Hit w/Consent Decree for Pump Systems

The U.S. Food and Drug Administration (FDA) has filed a consent decree against Medtronic. Inc., and two of the company’s officers – S. Omar Ishrak and Thomas M. Tefft – for repeatedly failing to correct violations relating to the manufacture of Synchromed II Implantable Infusion Pump Systems. The agency announced the legal action against the medical device maker on Monday.

The Synchromed II Implantable Infusion Pump Systems deliver medication to treat primary or metastatic cancer, chronic pain and severe spasticity. The device was approved by the FDA in 2004, and problems with the manufacture of the systems came to light in 2006. These problems can result in over- or under-infusion or a delay in therapy for patients. The FDA said in a press release on the agency’s website that the violations occurred at Medtronic’s Neuromodulation facilities in Columbia Heights, Minnesota, where the Synchromed II Implantable Infusion Pump Systems are made. [Read more…]

FDA Files Consent Decree Against Medtronic, Halting Sales of SynchroMed Implantable Drug Pumps

FDA Files Consent Decree, Halting Sales of SynchroMed Pumps

FDA Files Consent Decree, Halting Sales of SynchroMed Pumps

On Tuesday, the Food and Drug Administration (FDA) announced the filing of a consent decree against medical device maker Medtronic, Inc., and two of the company’s officers, CEO S. Omar Ishrak and senior vice president Thomas M. Tefft, for their repeated failure to correct violations related to the manufacture of the SynchroMed II Implantable Infusion Pump Systems. These pumps deliver medication to treat primary or metastatic cancer, chronic pain, and severe spasticity.

The violations occurred at Medtronic’s Neuromodulation facilities in Columbia Heights, Minnesota, where the pumps are manufactured, according to the FDA. The consent decree cites violations of the quality system (QS) regulation for medical devices, “which requires manufacturers to have processes in place to assure that the design, manufacture and distribution of a device allows for its safe use.” [Read more…]