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Mashup Score: 1FDA Update: Updated Use Instructions For Boston Scientific POLARx Cryoablation Ballon Catheters - American College of Cardiology - 21 hour(s) ago
The U.S. Food and Drug Administration (FDA) has announced that Boston Scientific Corporation is updating use instructions for POLARx and POLARx FIT Cryoablation Balloon Catheters, emphasizing the risk of esophageal fistula and best practices to minimize risk. These updates come following a higher than anticipated number of reports of esophageal injury, specifically atrio-esophageal fistula, after catheter ablation procedures for atrial fibrillation. Keywords: ACC Advocacy, United States Food and Drug
Source: www.acc.orgCategories: General Medicine News, CardiologistsTweet
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Mashup Score: 0FDA Update: Empty IV Containers Added to Medical Device Shortages List - American College of Cardiology - 11 day(s) ago
The U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) announced the addition of empty intravenous (IV) containers to the agency’s Medical Device Shortages List on Dec. 4. The shortage is expected to last through March 2025. According to the agency, “CDRH is working with manufacturers to identify and implement mitigations to address the shortage.” Keywords: ACC Advocacy, United States Food and Drug Administration
Source: www.acc.orgCategories: General Medicine News, CardiologistsTweet-
.@US_FDA has added empty IV containers to the agency's Medical Device Shortages List. Learn more ➡️ https://t.co/SY2zPqWso3 #FDAUpdate #ACCAdvocacy
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Mashup Score: 0FDA Update: Safety and Supply Concerns With VasoView HemoPro Endoscopic Vessel Harvesting Systems - American College of Cardiology - 1 month(s) ago
The U.S. Food and Drug Administration (FDA) posted a letter to health care providers on Nov. 15, announcing that Getinge/Maquet has issued an Urgent Medical Device Removal notice warning against use of the VasoView HemoPro 1.5 (VH-3500) and VasoView HemoPro 1 (VH-3000-W, marketed only outside the U.S) due to “risk that silicone may detach from the jaws of the harvesting tool during use.” With the removal of VasoView HemoPro 1.5 devices from use, the FDA has included endoscopic vessel harvesting devices
Source: www.acc.orgCategories: General Medicine News, CardiologistsTweet-
The @US_FDA has posted a letter to health care providers warning about safety and supply concerns with VasoView HemoPro endoscopic vessel harvesting systems. Learn more ➡️ https://t.co/QUjqJbxtWY #FDAUpdate #ACCAdvocacy
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Mashup Score: 3FDA Update: Abbott Medical Issues Correction For HeartMate LVAS Monitor - American College of Cardiology - 6 month(s) ago
The U.S. Food and Drug Administration (FDA) announced on June 28 that Abbott Medical has issued a correction for the HeartMate Left Ventricular Assist System (LVAS) Monitor due to screen issues that may cause unintentional pump stop. Screen issues exhibited by the HeartMate LVAS Monitor include screen freezing, overlapping buttons or screens, unresponsive buttons, distorted text or graphics, and wrong or missing information on the display. According to the agency, these issues may lead “a clinician user
Source: www.acc.orgCategories: General Medicine News, CardiologistsTweet-
#FDAUpdate 📢 @US_FDA announced Abbott Medical has issued a correction for the HeartMate Left Ventricular Assist System Monitor due to screen issues that may cause unintentional pump stop. Learn more: https://t.co/gS3DNSW3pv #ACCAdvocacy
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#FDAUpdate: Boston Scientific is updating use instructions for POLARx Cryoablation Balloon Catheters, emphasizing risk of esophageal fistula. Learn more ➡️ https://t.co/E7huaBhnHr #ACCAdvocacy