Will Medtronic’s MiniMed 640 Pump Glitch affect its PMA Status?

7/29/2015 Minnesota-based device giant Medtronic has issued letters to nearly 2,000 owners of the MiniMed 640 and 620 insulin pumps in Europe, warning them of a potential glitch in the reading mechanism. According to the letter, there is an error with the Bolus Wizard screen, causing it to not time-out and instead giving an outdated

Fiat-Chrysler hit with $105 Million Penalty for Response to over 20 Recalls

7/26/2015 Multiple sources are reporting that the National Highway Transportation Safety Administration (NHTSA) will issue Fiat-Chrysler a record $105 million fine for its lax response to 23 separate recalls involving over 11 million vehicles. The NHTSA conducted a public hearing earlier in the month regarding the company’s multiple safety issues, its first such hearing in

Former Executive Could Face Life for Peanuts

7/24/2015 The U.S. Probation Office has recommended that the former owner of Peanut Corporation of America, Stewart Parnell, be sentenced to life in prison for allowing several shipments of peanuts from facilities infected with salmonella. The peanuts led to the deadliest food outbreak in U.S. history from 2008-2009, causing nine deaths and over 700 illnesses

Ikea Issues Recall for 27 Million Dressers after Deaths of Two Children

7/23/2015 Ikea, the Swedish furniture icon, along with the Consumer Product Safety Commission (CPSC), has recalled seven million dressers from its popular Malm collection, along with 20 million other dressers and chests of drawers following the deaths of two children who were crushed in 2014. Although technically considered a recall, the CPSC and the company’s

NSAID Use Increases Heart Attack Risk

7/14/2015 Last week, the FDA increased the level of warning for NSIADS such as ibuprofen and naproxen. The new warning states that NSAID use increases heart attack risk.. The former warning stated that use “may” increase the risk. Non-steroidal anti-inflammatories (NSAIDS) are popular for their ability to relieve pain, reduce inflammation and lower fevers. They’re

Crappy Food Causes Queasy Texans

6/29/2015 Texas has been hit with a case of cyclospriasis, a nasty gastrointestinal illness transmitted by infected feces in water and food. A total of 54 Texans have had the parasite this year and 42 of those got sick in the last two weeks as crappy food causes queasy Texans. No source for this unpleasant

Hacked Medical Pumps Could Kill You

  6/11/2015 Billy Rios, a security expert conducting research on medical devices manufactured by Hospira, found deadly serious security flaws in drug delivery pumps. In short: hacked medical pumps could kill you. Currently, there are hundreds of thousands of Hospira pumps in hospitals throughout the U.S. I wrote a piece last month regarding an FDA

Ford Motor Company Recalls Almost 423K Vehicles

6/2/2015 Ford Motor Company recalls almost 423K vehicles in North America due to potential power steering failure. There is an intermittent electrical connection that can fail, putting the vehicles into manual steering mode thus making them harder to control. Ford reports four known crashes, but no injuries. The recall covers the following vehicles: Ford Flex