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Recalls

Abbott imaging catheter recall flagged as Class I by FDA

May 27, 2022 By Jim Hammerand

The FDA has identified the Abbott (NYSE:ABT) recall of its Dragonfly OpStar Imaging Catheter as a Class I recall. That’s the most serious level of a medical device recall, carrying the risk of serious injury or death. Five incidents, one injury and zero deaths were reported when Abbott initiated the recall on April 11. The […]

Filed Under: Blog, Cardiovascular, Catheters, Food & Drug Administration (FDA), Imaging, News Well, Recalls, Regulatory/Compliance, Vascular Tagged With: Abbott, FDA

FDA says Philips ventilator recall produced over 21,000 device reports, 124 deaths

May 20, 2022 By Sean Whooley

The FDA updated its communications on Philips‘ (NYSE:PHG) major ventilator recall with new data on device reports and patient deaths. In June 2021, Philips Respironics recalled millions of certain ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines due to potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement foam […]

Filed Under: Business/Financial News, Featured, Food & Drug Administration (FDA), News Well, Recalls, Regulatory/Compliance, Respiratory Tagged With: Philips, Philips Respironics, Royal Philips

FDA may order Philips to resolve respiratory devices recall

May 3, 2022 By Sean Whooley

The FDA has proposed an order requiring Philips (NYSE:PHG) to submit a plan for its recalled respiratory devices. FDA’s proposal regards the June 2021 recall of millions of certain Philips ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines due to potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement […]

Filed Under: Business/Financial News, Featured, Food & Drug Administration (FDA), News Well, Recalls, Regulatory/Compliance, Respiratory Tagged With: FDA, Philips, Philips Respironics, Royal Philips

Medtronic investigates HVAD pump welds after patient deaths

April 29, 2022 By Jim Hammerand

Medtronic (NYSE:MDT) is investigating a new problem with its HeartWare Ventricular Assist Device (HVAD) nearly one year after halting sales and new implantations of the device. Fridley, Minnesota-based Medtronic said it received three complaints of suspected pump thrombosis in patients. Two of the patients died after their heart pumps were exchanged. Medtronic found a malfunction when inspecting […]

Filed Under: Blog, Cardiac Implants, Cardiovascular, Featured, Food & Drug Administration (FDA), Implants, News Well, Recalls, Regulatory/Compliance Tagged With: FDA, Medtronic

Recall of Medtronic’s Harmony delivery catheter is Class I

April 26, 2022 By Sean Whooley

The FDA today announced a Class I recall — the most serious kind — for the Medtronic (NYSE:MDT) Harmony delivery catheter system. Medtronic designed the Harmony transcatheter pulmonary valve (TPV) system for treating a leaky native or surgically repaired right ventricular outflow tract (RVOT). It consists of a transcatheter pulmonary valve and a delivery catheter (the […]

Filed Under: Cardiac Implants, Cardiovascular, Catheters, Featured, Food & Drug Administration (FDA), News Well, Recalls, Regulatory/Compliance, Replacement Heart Valves, Structural Heart Tagged With: FDA, Medtronic

Medtronic warns on some Percept neurostimulators

April 26, 2022 By Sean Whooley

Medtronic (NYSE:MDT) has issued an urgent field safety notice in Europe regarding its Percept PC implantable neurostimulator (INS). The letter informs users that, in rare instances (0.044%), the Percept PC INS Model B35200 can’t communicate with the clinician programmer and/or the patient programmer system (HH90 Handset and TM91 Communicator). According to the safety notice, in […]

Filed Under: Featured, Implants, Neurological, Neuromodulation/Neurostimulation, News Well, Recalls, Regulatory/Compliance Tagged With: Medtronic

DOJ subpoenas Philips over Respironics recall; CEO addresses investigation

April 25, 2022 By Jim Hammerand

Royal Philips (NYSE:PHG) today disclosed a Department of Justice subpoena for information related to the massive recall of Respironics respiratory devices. Philips Respironics and Philips subsidiaries in the U.S. received the subpoena on April 8 seeking “information related to events leading to the Respironics recall,” the Amsterdam-based company said as it announced its latest financial […]

Filed Under: Blog, Business/Financial News, Featured, Food & Drug Administration (FDA), Legal News, News Well, Otolaryngology/Ear, Nose & Throat (ENT), Recalls, Regulatory/Compliance, Respiratory Tagged With: Department of Justice, FDA, Philips, Philips Respironics, Respironics, Royal Philips

Philips shares take a dive as supply chain issues, ventilator recalls impact Q1 results

April 25, 2022 By Sean Whooley

Royal Philips (NYSE:PHG) shares took a hit today on first-quarter results that felt the effects of ongoing issues with supply chain and recalls. PHG shares were down 12.1% at $26.67 in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was virtually even on the […]

Filed Under: Business/Financial News, Featured, Food & Drug Administration (FDA), MassDevice Earnings Roundup, Recalls, Regulatory/Compliance, Respiratory, Wall Street Beat Tagged With: Philips, Philips Respironics, Royal Philips

Philips has another round of serious ventilator recalls

April 20, 2022 By Sean Whooley

Royal Philips’ (NYSE:PHG) ventilator problems continue as the company has issued further recalls for its respiratory devices. FDA earlier this week said it was designating more Philips recalls as Class I — the most serious kind. The recalls involve all models of the Philips Respironics V60 ventilator, the V60 Plus ventilator and the V680 ventilator […]

Filed Under: Business/Financial News, Featured, Food & Drug Administration (FDA), News Well, Recalls, Regulatory/Compliance, Respiratory Tagged With: FDA, Philips, Philips Respironics, Royal Philips

FDA can’t explain record-low medical device recalls

April 8, 2022 By Danielle Kirsh

Medical device product recalls were down 14.3% in the federal government’s fiscal year 2021, according to a recent Medical Design & Outsourcing analysis of recall data. The drop was the biggest since the FDA began publicly reporting the data in 2013, and came as the regulating agency put more emphasis on fighting the COVID-19 pandemic. We reached […]

Filed Under: Featured, News Well, Recalls, Regulatory/Compliance Tagged With: FDA

Medtronic issues voluntary recall for certain In.Pact drug-coated balloon catheters

March 31, 2022 By Sean Whooley

Medtronic (NYSE:MDT) announced today that it voluntarily recalled a subset of its In.Pact Admiral and In.Pact AV balloon catheters. The company initiated the recent recall of the paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheters due to the potential for pouch damage resulting in a loss of sterility. Get the full story at our sister site, Drug […]

Filed Under: Cardiovascular, Catheters, Drug-Device Combinations, Featured, News Well, Recalls, Vascular Tagged With: Medtronic

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