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Home » Topics » Medical Devices » Postmarket Safety

Postmarket Safety
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Medtronic Voluntarily Pulls Thoracic Stent Grafts

February 18, 2021
The company is conducting a comprehensive root cause investigation. Read More

MedAlliance Enrolls First Patient in Postmarket Study for Drug-Eluting Balloon

February 12, 2021
The single-arm study will span at least 50 sites in Europe, Asia and South America, and will involve patient follow-up at 30 days, six months, then every year for five years. Read More

Silk Road Medical Pulls More Lots of Stent System

January 26, 2021
The company warned that the issue could cause serious injuries or death but said it has not received reports of either. Read More
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Curative’s COVID-19 Test May Give False Results, FDA Warns

January 7, 2021
Healthcare providers that used the test and suspect a recent inaccurate result should consider retesting patients with a different COVID-19 test, the agency said. Read More

Penumbra Recalls Catheter Due to Distal-Tip Damage

January 1, 2021
The reported failures included ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the catheter’s distal-tip region. Read More

FDA Issues Update on Cook Medical Catheter Recall

December 29, 2020
While there have been no reported deaths, there have been 57 complaints and 14 reports of serious injuries stemming from the issue, the FDA said. Read More

Penumbra Recalls Catheters Following Patient Deaths, Injuries

December 17, 2020
“The Jet 7 Xtra Flex catheter “is not able to withstand the same burst pressures” to failure as the manufacturer’s other large-bore aspiration catheters used to remove thrombus in acute ischemic stroke patients,” the agency said. Read More
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DHS Finds Vulnerabilities in Medtronic’s Heart Implant Reader

December 14, 2020
“Successful exploitation of these vulnerabilities together could result in the attacker being able to modify or fabricate data from the implanted cardiac device being uploaded to the CareLink Network and remotely execute code … which could allow control of a paired cardiac device,” DHS warned. Read More

FDA Warns of Heater-Cooler Device Infection Risks

October 14, 2020
“Nontuberculous mycobacteria (NTM) patient infections, NTM device contamination and, in some cases, both issues have now been reported for all manufacturers of heater-cooler devices in the U.S.,” the FDA noted. Read More

Smith & Nephew Recalls Suture-Based Repair Systems

September 21, 2020
The company said unused devices should be sent to a Smith & Nephew agency or distributor. Read More

FDA Labels Becton Dickinson’s Infusion Pump Recall as Class I

September 16, 2020
Use of the defective devices could lead to patient injury or death, the agency warned, noting that 1,186 issues and a single injury have been reported so far. Read More

Australia TGA Warns of Risks in Hip Replacement Components

August 31, 2020
The agency said hip replacements in 2012 or earlier may have used the component. Read More
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