May 14th, 2008 joshua
Atrium Medical Corporation announced it is recalling selected lots of the Hyrdraglide brand heparin-coated Thoracic Drainage catheters because they contain a contaminated dose of the blood thinner.
Atrium has not received any reports of adverse reactions to the catheter’s use in patients, but is initiating the recall because it found in samples of the devices, the […]
May 9th, 2008 amy
In the wake of the Brooklyn body parts scandal trial in which Christopher Aldorasi was convicted this week and the earlier guilty plea of the scheme’s mastermind, Michael Mastromarino, State Senator Martin Golden is now urging New York lawmakers to ban all sales of body parts, the Brooklyn Daily Eagle reports.
While it has always been […]
May 9th, 2008 joshua
Medtronic Inc. said it is recalling some disposable devices used during cardiac bypass surgery because they have been found to be coated with contaminated traces of heparin, Reuters reports.
The devices are coated with Carmeda BioActive surface, which contains the blood thinning drug basically under a worldwide recall following the deaths of at least 81 patients […]
May 8th, 2008 laurie
Medtronic Inc., the maker of the defective Sprint Fidelis Defibrillator Leads linked to patient injuries and death, has announced it is scaling back its job force. It plans to cut 1,100 jobs this year in sectors of the corporation “no longer growing at previous rates,” a report from Bloomberg News states.
A spokesperson for the company […]
May 7th, 2008 amy
Medtronic’s Physio-Control Inc suspended shipments of of its LIFEPAK defibrillators in January 2007, citing vague “quality control system issues.” But court documents filed last week shed a little more light on what Medtronic is hiding. The FDA’s injunction against Medtronic and Physio-Control cites 11 violations, reported by FDA inspectors during a 2006 visit.
These violations include:
Failure […]
May 6th, 2008 joshua
The Food and Drug Administration recently found insulin pumps, used to treat Type 1 diabetes by tens of thousands of teenagers, to be linked to injuries and deaths.
Parents are being encouraged to monitor their child’s use of an insulin pump, especially in younger children. The FDA is not recommending patients stop using the pumps, but […]
May 6th, 2008 amy
The Mentor ObTape Vaginal Sling was designed to help women with bladder incontinence, but what it’s done has caused women to suffer from even more serious problems.
An estimated 35,000 women were implanted with the Mentor ObTape Vaginal Sling, a mesh strip to help the bladder not leak. But when the mesh began to move […]
May 5th, 2008 amy
The FDA has sent another warning letter to Stryker, this time over problems in the company’s small Biotech division. Biotech makes products that promote bone growth.
CNNMoney.com reports that the FDA letter is related to quality systems and compliance issues in the Biotech unit’s Hopkinton, Mass., facility, according to Stryker. Issues include the falsification of hospital-approval […]
May 2nd, 2008 amy
Pain pump shoulder injuries caused by the use of intra-articular pain pumps in shoulder surgeries causes a condition called Postarthroscopic Glenohumeral Chondrolysis (PAGCL) more often than many healthcare professionals seem to realize. Unfortunately, PAGCL is one of the most common complications that can follow shoulder surgeries.
The condition is caused by the intra-articular pain pump […]
May 2nd, 2008 joshua
There is a massive Help Wanted sign outside FDA headquarters, according to Bloomberg News.
The regulatory agency announced it is looking to fill 1,300 positions by the end of September. The figure stands as three times the amount of staff hired by the FDA in the past two years.
Among the 1,300 positions are 600 new jobs […]
