On January 21, 2020, “Cardinal Health informed customers of a voluntary recall for the surgical gowns produced by a contract manufacturer after discovering that some gowns were produced in unapproved locations that did not maintain proper environmental conditions as required… Read More
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FDA Issues Class I Recall Of Syringe Pumps Due To Malfunctioning Alarms
The FDA has issued a Class I recall of certain Medfusion® 4000 Syringe Pumps with Firmware Version 1.7.0 manufactured by Smiths Medical ASD, Inc. because the firmware could potentially cause the low battery alarms to stop working. If the battery… Read More
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Alaris™ Pump Modules Model 8100 Recalls
In a recall notification sent on April 15, 2019, Becton, Dickinson and Company (“BD”) informed clinicians that the bezel assemblies in certain Alaris Pump Modules Model 8100 manufactured between April 2011 and June 2017 were manufactured with a specific type… Read More
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Kaiser Health News Reports On FDA’s “Hidden” Database Of Malfunctions Of Medical Devices
Kaiser Health News reported on June 27, 2019 that its investigation found that “[medical] device manufacturers, for the past two decades, had been sending reports of injuries or malfunctions to the little-known database [alternative summary reporting database], bypassing the public… Read More
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FDA Issues Safety Communication Regarding The Stryker Wingspan Stent System
The FDA issued a Safety Communcation on April 25, 2019 entitled, “Use of the Stryker Wingspan Stent System Outside of Approved Indications Leads to an Increased Risk of Stroke or Death: FDA Safety Communication” in which the FDA warned: “a… Read More
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Medtronic Issues Urgent Recall Of Nearly 157,000 Dual Chamber Pacemakers
Medtronic has issued an “Urgent Medical Device Recall” voluntarily recalling and suspending distribution of a subset of Medtronic dual chamber pacemakers distributed worldwide between March 10, 2017 and January 7, 2019 under the brand names Adapta; Versa; and Sensia. The… Read More
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Olympus Medical Systems Corporation Pleads Guilty To Failing To Report Infections Associated With Its Duodenoscopes
The U.S. Department of Justice announced on December 10, 2018 that Olympus Medical Systems Corporation (“Olympus”), and a former senior executive in Japan, have pled guilty to failing to file required adverse event reports involving infections connected to its duodenoscopes,… Read More
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Defective Medical Devices Caused 1.7 Million Injuries, 83,000 Deaths In U.S.
The Implant Files, which is a global investigation that tracks the harm caused by medical devices that have been tested inadequately or not at all, analyzed more than 8 million device-related health records, including death and injury reports and recalls,… Read More
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FDA Issues Proposed Cybersecurity Recommendations For Medical Devices
Imagine you or a loved one has an implanted medical device, such as a heart pacemaker, that may be hacked and controlled by someone other than the manufacturer or your doctor. Someone could conceivably control the device such that you… Read More
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$33M New Jersey Pelvic Mesh Verdict
Yesterday, a New Jersey pelvic mesh jury returned its verdict for compensatory damages in the total amount of $33 million in favor of a woman and her husband against C.R. Bard, Inc. (“Bard”), finding that Bard knew that its pelvic… Read More
