Claris Law Legal Blogging Community

Name:

E-mail:

Phone Number:

Zip Code:

Your Question:

Editor: Marc Jay Bern
Profession: Defective Medical Device Lawyer

Medtronic Recalls Heparin-Coated Devices

Category: Medtronic Recalls

Medtronic is recalling some of its devices used in heart bypass surgery because the coating includes traces of heparin, a blood thinner, which in larger quantities has recently been linked to 81 deaths.

Continue reading "Medtronic Recalls Heparin-Coated Devices"

Medtronic's Intrathecal Infusion Pumps Recalled

Category: Medtronic Recalls

On March 21, the FDA announced a Class 1 recall for Medtronic Neuromodulations implantable infusion pumps.

Affected devices include: SynchroMed EL (models 8626-10, 8626-18, 8626L-10, 8626L-18, 8627-10, 8627-18, 8627L-10, and 8627L-18), SynchroMed II (models 8637-20 and 8637-40), and IsoMed (models 8472-20, 8472-35, and 8472-60).

Continue reading "Medtronic's Intrathecal Infusion Pumps Recalled"

Medtronic SynchroMed El Pumps Recalled by the FDA

Category: Medtronic Recalls

The SynchroMed EL pump, by Medtronic, has been recalled by the FDA because the pump motors can potentially stall, stopping pain-relieving drugs from being dispensed to the patient.

Continue reading "Medtronic SynchroMed El Pumps Recalled by the FDA"

FDA Medical Device Approvals Examined

Category: Medtronic Recalls

A House committee, in response to the recent Class I recall of Sprint Fidelis defibrillator leads, is requesting additional information from the FDA on its regulation of heart-device components, specifically defibrillator leads.

Continue reading "FDA Medical Device Approvals Examined"

FDA Issues Class I Recall of Medtronic Defibrillator Leads

Category: Medtronic Recalls

On October 15, 2007, The U.S. Food and Drug Administration (FDA) issued a Class I Recall of Medtronic Sprint Fidelis defibrillator leads due to a fracture risk that can lead to unwanted shocks being applied to the implanted patients heart.

Medtronic advises patients who are implanted with this lead or do not know the model of their lead, to contact their physicians for further information as soon as possible.

Continue reading "FDA Issues Class I Recall of Medtronic Defibrillator Leads"

Patients Concerned About Medtronic Recall

Category: Medtronic Recalls

When Medtronic warned doctors to stop using faulty Sprint Fidelis leads attached to heart defibrillators, they also advised patients with implanted devices to consult their medical doctors.

Continue reading "Patients Concerned About Medtronic Recall"