The FDA released a flurry of recalls for medical devices this week.
First, iCad Inc. (NSDQ:ICAD), formerly Xoft Inc., had to remove a radiation guard for breast cancer treatment, over reports that the device sheds tungsten particles.
The FDA issued the Class I recall for Sunnyvale, Calif.-based company’s Axxent FlexiShield Mini, Model F5300. The Food & Drug Administration issues Class I recalls when there is potential for serious injury or death from use of a particular device or product.
The recall came on reports that tungsten particles from the shielding devices became lodged in the breast tissue of women who were treated with the device during intraoperative radiation therapy (IORT). iCad was sued last month over the tungsten deposits found in patients’ breast tissue after treatment with the devices in a California Hospital.
iCad bought out Axxent maker Xoft late last year for about $13.1 million in stock and cash.
The agency said that there isn’t evidence that the tungsten particles are toxic, and no "permanent impairment of bodily functions or permanent damage to body structures is anticipated," according to the FDA. Only "a few" effects have been reported in humans with Tungsten and each of which involved exposure to much higher levels, the agency said.
The recall affects lot numbers 800218, 800239, 800240, 800321, 800334 and 800335, which were manufactured between Sept. 11, 2009 and June 28, 2010. iCad sent a letter to its customers about the defect on Feb. 3.
In other recall news, the agency also issued a Class 1 recall of an aneurysm treatment device made by Penumbra Inc.
The Penumbra device is a platinum coil designed that is placed into a brain aneurysm through the blood vessels. The device’s implantation system includes a tool used to insert it inside a patient. According to the FDA, the pull wire on the delivery tool can slip out of place and allow premature detachment of the coil, which may cause the coil to slip into the blood stream and lead to serious injury including blood clots and stroke.
The recall affects lot numbers F17211 to F18553. Penumbra began contacting its customers about the defect on March 4 and said that it can account for all affected lots.
The FDA also issued a class I recall for Moog’s infusion pumps after it found that a software error in the pumps can cause them to shut down prematurely and cause patient death or serious injury, according to the FDA.
The recall includes Moog’s Curlin 6000 CMS, Curlin 6000 CMS IOD, PainSmart and PainSmart IOD devices manufactured and given software updates from May 2007 to February 2011, according to the company.
The company notified its customers of the defect on Feb. 28 and reports that no adverse events related to the software glitch occurred.
The FDA also warned Royal Philips Electronics NV (NYSE:PHG) on automated external defibrillator defects.
The agency sent a warning letter in late March to Philips about its automated external defibrillators (AEDs). However, the agency said the company failed to correct defects in its HeartStart AEDs, which led to deaths, according to the FDA letter. The FDA found violations during an inspection at the company’s Seattle facility last year, the letter said.
The company does not expect the warning letter to cause disruptions in shipments, according to Dow Jones Newswires.
The Dutch company has experienced significant problems with its HeartStart devices. In Sept. 2009, the company issued a recall of about 5,400 of its HeartStart FR2+ AEDs after discovering a microchip failure that "may render the device inoperable."
Finally, the FDA announced last week the launch of a consumer-friendly web search tool for recalls.
The new search option for the FDA’s website was created after the FDA Food Safety Modernization Act, which was signed into law in January, called for the agency to address its hard-to-navigate website.
None of the above recalls were listed in the FDA’s new system at the time of publication
