If you’ve ever had to have a surgery, you know the fear that comes along with it. Will I be ok? Is this the right thing for me to do? What will happen if I have trouble? There are just so many uncertainties, and unfortunately when going under the knife, there is nothing you can [...]
Topic | Medical Device Recalls RSS feed for this section
Some Can Breathe Easier Due To Ventilator Recall That Is Potentially Saving Lives
According to various media reports, Respironics Inc.’s recall of a portable ventilator model, Respironics Trilogy 100, is nearly complete, the manufacturer said Thursday, January 12, 2012. The recall was initiated in October 2011 after internal reviews discovered a problem with the blower. Respironics notified its United States distributors, providers, sales personnel and customers of the recall [...]
Recall Of Operating Tables Could Mean Life Or Death For Surgical Patient
Imagine if you will the scenario of you being operated on and all of a sudden the operating table suddenly moved or tilted during the surgery. I honestly couldn’t imagine. But, apparently there have been a number of reported injuries to the FDA of this exact thing happening. Reports that Mizuho operating tables could suddenly [...]
Public Citizen group calls on FDA for transvaginal mesh recall
A public advocacy group, Public Citizen, founded by Ralph Nader, is asking the U.S. Food and Drug Administration to recall transvaginal surgical mesh products that help repair pelvic organ prolapse and stress urinary incontinence, just as the industry is preparing a broad response.
Baxter HomeChoice Dialysis Systems Recalled
Company, Product(s): Baxter Healthcare Corporation HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems Recall Class: Class I Date Recall Initiated: January 8, 2010 Product Names: Baxter Healthcare Corporation, HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems. These systems have been distributed since 1994.
ReliOn insulin syringes recalled
The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as [...]
HeartMate II left ventricular assist system recalled
Thoratec Corporation recalled the HeartMate II Left Ventricular Assist System. The HeartMate II is a high speed, electric, axial flow, rotary blood pump. The pump drains blood from the heart.
Medical Device Disaster: Medtronic Recalls Defibrillators
Medtronic announced it was voluntarily suspending distribution of its Sprint Fidelis defibrillation leads because a small number of fractures have been detected. As a result of Medtronic’s action, no more Sprint Fidelis leads will be sold or manufactured and any remaining product should be pulled from inventory and returned to the company. Patients who are [...]
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Latest Drug Injury News
A Fake Cancer Drug Infuriates Real Cancer Patients
Cancer patients are furious that a counterfeit version of the drug Avastin has landed in U.S. clinics. But, who wouldn’t be when your life is on the line? Definitely can’t blame them one bit! The counterfeit version was just discovered at U.S. health care facilities, prompting the maker of the cancer drug to warn doctors [...]
Another Dietary Supplement, RegenArouse, Recalled By FDASeems like lately we’ve written a lot about dietary supplements. Apparently the FDA is cracking down on dietary supplements that contain ingredients that have not been approved by the FDA. Just last week we told you about the recall that Healthy People Co made due to unlisted ingredients, and now, RegenArouse is the latest to [...]
New Study Questions Controversial Lung Cancer TreatmentA recent study is questioning a controversial radiation treatment for lung cancer, that may not benefit the life expectancy of a cancer patient. The treatment, Postoperative radiotherapy (PORT), according to U.S. researchers, may not help increase the life span of elderly patients, said Reuters Health. PORT is believed to help minimize the likelihood of a [...]
New FDA Recommendations To Prevent Another Heparin ContaminationFour years after US drug-maker Baxter International’s blood thinner heparin was contaminated in China, causing dozens of deaths, lawmakers urged the FDA to prevent another heparin scare, during a recent hearing at the U.S. House of Representatives. Therefore, US regulators issued draft guidelines to ensure the safe production of the blood-clot prevention. “We’re making sure [...]
Heartburn Meds Linked To A Diarrhea That Just Won’t Go AwayHeartburn is a frustrating thing to have to deal with, but chronic heartburn is just down right aggravating. One way to treat it is by taking a medication called Proton Pump Inhibitors (PPIs). PPI’s are available by a prescription, and over the counter. Prescription PPIs are used to treat conditions such as gastroesophageal reflux disease [...]
Latest Medical Device Injury News
Two California Surgery Centers Halt Lab Band Surgeries At Least Temporarily
Just a few weeks ago we reported the controversy around 1-800-GET-THIN promotion in Southern California. There are several reports of patients dying, as well as possible fraudulent activity. Now, a pair of southern California clinics that advertise via the 1-800-GET-THIN promotion have agreed to stop performing Lap-Band gastric band weight-loss procedure. “Unfortunately, recent allegations question [...]
Latest Info On Metal On Metal Hip ImplantsDoctors have known for several years that some hip devices, in which both the ball and cup are made of metal, were failing at faster rates than other hip implants. Now, new research is confirming this information and claiming that the problem can cause trouble for many years to come, even after removal. “This is [...]
Medical Device Industry And FDA Reach Fee Agreement After Negotiations Took PlaceJust a few weeks ago, we reported that the FDA had missed a January 15 deadline to submit a new agreement on medical device fees to U.S. lawmakers. Well, apparently negotiations are over. The FDA and medical device makers have reached an agreement on the fees. Device makers will double product review fees paid to [...]
Lap-Band Surgery Centers In Hot Water With Death Toll Rising & Possible Fraudulent ActivityJust last week we reported that a group of Democratic lawmakers were calling on the Republicans who control the House Energy and Commerce Committee for a safety review concerning 2 controversial medical devices. Now it just so happens that one of those devices, The Lap-Band, is again in the news, and the topic of this [...]
Johnson & Johnson Suffering From Manufacturing Issues and RecallsThe drug & medical device giant Johnson & Johnson seems to be a name that is coming up a lot lately; from the controversial chemicals found in baby products to the major artificial hip recall surrounding DuPuy Orthopaedic’s, they continually seem to be on the radar. Now, in their just released last quarter financial statement [...]
