Medical Device Recalls Nearly Doubled in a Decade; Sharp Increase Where Defective Product Carried Reasonable Probability of Death, FDA Says

Medical Device Recalls Nearly Doubled in a Decade
Sharp Increase Where Defective Product Carried Reasonable Probability of Death, FDA Says
March 21, 2014 12:06 a.m. ET
Recalls of defective medical devices nearly doubled in the decade from 2003 through 2012, according to a Food and Drug Administration report due Friday.The total number of recalls rose to 1,190 in 2012, up from 604 in 2003. There was a sharp increase in recalls where the defective product carried a reasonable probability of death. In 2012, there were 57 of these so-called Class I recalls, up from seven in 2003.
The analysis by the FDA’s center for medical devices was undertaken in part to respond to a 2011 report by the Government Accountability Office. That document noted that recalls by companies often came too late to do much about the defects in products, since thousands of them had already been implanted in patients. A recall means a product is removed from the market, or that it is corrected in response to a defect.
An example of a device that was hard to retrieve was the 2007 recall by Medtronic Inc.MDT -0.45% of its Sprint Fidelis defibrillator wires, or “leads.” These tended to fracture in a small number of patients, resulting in some patient deaths. About 268,000 of them had been implanted in patients before the recall, and many of those still were implanted at the time.
Medtronic has said its system in which doctors’ offices monitor patients remotely now provides an early warning if the device is about to fail.
Steve Silverman, director of the FDA medical device center’s office of compliance, said a portion of the recalls stemmed from inspections by the agency. Others, he said, followed a 2010 workshop the agency held on reducing unnecessary radiation exposure from X-rays and such imaging devices. The workshop made hospitals more acutely aware of the issue of high dosing, so more flaws were reported.
He said he wasn’t able to provide numbers of devices or patients covered by the recalls, but said, “The rate of recall lags industry growth.” The FDA said the numbers of medical devices increased by about 25% from 2008 through 2012.
Wanda Moebius, a senior vice president at the industry trade group AdvaMed, said, “The increase in recalls reflected in the data can be attributed primarily to companies taking a more cautious, pro-active, patient-centric approach to quality, safety and reporting of events to FDA.”
Diana Zuckerman, president of the National Research Center for Women & Families and a critic of FDA device regulation, said, “You have to wonder whether a more rigorous regulatory effort before devices went on the market would have avoided these recalls.”
Marcia G. Crosse, health-care director at GAO, said, “The very fact that they are analyzing data on this is an improvement, as they weren’t doing this when we reported in 2011.”

About bambooinnovator
Kee Koon Boon (“KB”) is the co-founder and director of HERO Investment Management which provides specialized fund management and investment advisory services to the ARCHEA Asia HERO Innovators Fund (, the only Asian SMID-cap tech-focused fund in the industry. KB is an internationally featured investor rooted in the principles of value investing for over a decade as a fund manager and analyst in the Asian capital markets who started his career at a boutique hedge fund in Singapore where he was with the firm since 2002 and was also part of the core investment committee in significantly outperforming the index in the 10-year-plus-old flagship Asian fund. He was also the portfolio manager for Asia-Pacific equities at Korea’s largest mutual fund company. Prior to setting up the H.E.R.O. Innovators Fund, KB was the Chief Investment Officer & CEO of a Singapore Registered Fund Management Company (RFMC) where he is responsible for listed Asian equity investments. KB had taught accounting at the Singapore Management University (SMU) as a faculty member and also pioneered the 15-week course on Accounting Fraud in Asia as an official module at SMU. KB remains grateful and honored to be invited by Singapore’s financial regulator Monetary Authority of Singapore (MAS) to present to their top management team about implementing a world’s first fact-based forward-looking fraud detection framework to bring about benefits for the capital markets in Singapore and for the public and investment community. KB also served the community in sharing his insights in writing articles about value investing and corporate governance in the media that include Business Times, Straits Times, Jakarta Post, Manual of Ideas, Investopedia, TedXWallStreet. He had also presented in top investment, banking and finance conferences in America, Italy, Sydney, Cape Town, HK, China. He has trained CEOs, entrepreneurs, CFOs, management executives in business strategy & business model innovation in Singapore, HK and China.

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