Complications with Left Atrial Appendage Occlusion (LAAO) Devices More Likely Among Women Than Men, FDA Warns
The FDA is warning that a form of heart surgery used to treat atrial fibrillation appears to carry greater health risks for women than men.
Tag Archives: Boston Scientific
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FDA Releases Final Result of Boston Scientific Transvaginal Mesh Studies
New postmarketing surveillance studies show Boston Scientific transvaginal mesh increase the risk of health complications for pelvic organ prolapse patients, without adding any additional effectiveness or safety over traditional surgical…
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Ingenio Pacemaker, CRT-P Recall Issued After Dozens of Incidents and Patient Injuries
About 48,000 Boston Scientific Ingenio pacemakers and CRT-Ps are being recalled due to a malfunction which could put them into "safety mode", preventing life-saving corrections to patients' heart rhythm.
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Vici Venous Stent Recall Follows Reports of Stent Migration
Nearly 32,000 stents use to prevent blockages in the veins are being recalled due to the risk of migration and patient injury.
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Boston Scientific Mesh Settlement Results in $189M Payments to Resolve State Attorneys General Lawsuit
Boston Scientific will pay $187 million to resolve claims by most states that it misled both women and state health agencies over the safety and efficacy of transvaginal mesh products.
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Boston Scientific S-ICD Defibrillator Electrode Recall Due To Fracture Risk
Boston Scientific is recalling tens of thousands of ICD electrodes which may fail to deliver life-saving shocks to patients with ICDs, and have already been linked to serious injuries and…
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Boston Scientific Recalls and Discontinues Lotus Edge Aortic Valve System For TAVR Surgeries
Boston Scientific is recalling and removing its Lotus Edge TAVR system from the market due to problems with the complexity of the delivery system.
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Boston Scientific Catheter Recall Issued Over Tip Detachment Risks
The FDA warns that certain Boston Scientific catheter tips could break off inside of patients' blood vessels, putting them at risk of serious injury or death.
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First Fully Disposable Duodenoscope Approved By FDA
The FDA has approved the first fully disposable duodenoscope in an effort to eliminate the risk of infections linked to ineffective sterilization techniques.
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Boston Scientific Mesh Lawsuit Filed After FDA Forces Recall for Remaining Products on Market
A vaginal mesh lawsuit indicates Boston Scientific mesh devices caused severe injuries, complications and the need for surgery.