The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product (Include the following information) HVAD Pump Implant Kits for the HeartWare HVAD System RMS (supplier) Lots: 8721869-001-01 8722375-001-01 8722375-002-02 Model: Medtronic HVAD Pump Implant Kits, labeled as:…
Medtronic Announces Voluntary Recall of Unused Valiant Navion™ Thoracic Stent Graft System
Summary Company Announcement Date: February 23, 2021 FDA Publish Date: February 23, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Due to endoleaks, stent fractures and stent ring enlargement Company Name: Medtronic Brand Name: Brand Name(s) Medtronic Valiant Navion™ Product Description: Product Description Thoracic stent graft system Company Announcement Medtronic plc (NYSE:MDT),…
Pet Turtles: Cute But Commonly Contaminated with Salmonella
Image Turtles commonly carry the Salmonella bacteria on their outer skin and shell surfaces. Reptiles like bearded dragons and geckos can also infect people with Salmonella. These little glassy-eyed creatures may look cute and harmless, but small turtles and reptiles like bearded dragons and geckos can make people very ill. People can get infected with Salmonella…
Hillrom Recalls Liko Multirall 200 Overhead Lift Due to Failure to Properly Attach Q-Link Strap Lock (Also Known as Q-Link 1 Strap Lock) to S65 Hook
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Products Hillrom Liko Multirall 200 Overhead Lift Model Number, Product Codes, Catalog or Lot numbers: Liko Multirall 200 (product number 3130001) Universal SlingBar 450 R2R (product number…
Pulse Oximeter Accuracy and Limitations: FDA Safety Communication
Date Issued: February 19, 2021 The Coronavirus Disease 2019 (COVID-19) pandemic has caused an increase in the use of pulse oximeters, and a recent report (Sjoding et al.) suggests that the devices may be less accurate in people with dark skin pigmentation. The U.S. Food and Drug Administration (FDA) is informing patients and health care…
How AEDs in Public Places Can Restart Hearts
Image Español Sudden cardiac arrest occurs when the heart suddenly and unexpectedly stops pumping blood. It can happen to anyone, at any time, and signs include sudden collapse and immediate loss of consciousness. Unlike heart attacks, which are caused by a blockage in an artery to the heart, sudden cardiac arrest is caused when the…
Boston Scientific Corporation Recalls EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) System Due to Risk of Short-Circuit
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product (Include the following information) EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) Lots: See below Model: S-ICD A209 and MRI S-ICD A219 Distribution Dates: June 1, 2015 – September…
Tattoo Removal: Options and Results
[embedded content] Español That tattoo on your arm of a former flame—the one that seemed like a great idea years ago—is kind of embarrassing today. And your spouse is not too crazy about it either. But removing a tattoo isn’t as easy as it might seem. It can be painful, and risks include possible scarring and…
Eliminación de tatuajes: Opciones y resultados
[embedded content] English Ese tatuaje de un antiguo amor que tiene en el brazo —el que parecía una gran idea hace años— ya no es tan atractivo. Y tampoco enloquece a su esposa. Eliminar el tatuaje no es tan fácil como pudiera parecer. Puede ser doloroso y conllevar riesgos tales como cicatrices e infecciones. Sin…
Transcript: FDA D.I.S.C.O.: FDA approval of Xalkori (crizotinib) and Darzalex Faspro (daratumumab plus hyaluronidase)
Podcast Welcome to the DISCO, FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on two recent FDA cancer drug approvals. On January 14, 2021, the FDA approved crizotinib (brand name Xalkori)…