The FDA has received 26 Medical Device Reports, with no deaths and one (1) injury from January 1, 2018 to March 23, 2020. Who May be Affected … Before the COVID-19 outbreak in the first quarter of 2020, there were sever significant events in the recall arena, including: Medical device software issues accounted for the highest number of recalls heading into four years straight. The .gov means it’s official.Federal government websites often end in .gov or .mil. Recalling Firm. This is a different alert to that issued on 4 March 2020 for Emerade 150 microgram auto-injectors.. Z-0808-2020 - Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. Software issues were the most common reason behind medical device recalls, accounting for 296 of … Medical Device Recalls. 13. 15. A Class I medical device recall is the most serious, meaning that use of the medical device could cause serious injuries or death. Mavidon and the FDA urge healthcare providers and facilities to check their medical devices to see if they are subject to this recall. Here is what we know about the recall. Recalls Alaris™ System Pump Module and Pump Module Door Assembly Replacement Kits Due to the Potential for Stuck or Unresponsive Keys, Becton Dickinson (BD) CareFusion 303 Inc. Dec. 23, 2020 FDA's list of medical device recalls in 2020 contains 32 separate entries, with infusion pumps appearing most frequently, followed by catheter issues related to detachment or separation of parts of the device. Recalls Alaris™ System PC Unit and PC Unit Front Case Keypad Replacement Kits Due to Risk of Stuck or Unresponsive Keys, Smiths Medical Recalls Medfusion 3500 and 4000 Syringe Pumps Due to Risk of Medication Delivery Error, CME America Updates Recall of BodyGuard Infusion Pump System Due to Risk of Over-, and Under-infusion, Verathon, Inc. Boston Scientific Corporation Recalls Imager II Angiographic Catheters Due to Tip Detachment The FDA has identified this as a Class I recall, the … If you wish to find information on a recall, or a correction or removal action that has not yet been classified, you can search the Medical Device Recalls Database. Sign up to receive email updates on medical device recalls, safety communications, and other safety information. Recalling Firm. However, it was unclear whether the bill would become law as pharmaceutical industries reported that they largely comply with FDA recall requests. Allergan breast implants. Please note that the FDA lists medical device recall notices by the date that it posts the recall rather than the recall initiation date. Childproof packaging recalls … The list below contains recalls that were issued in 2020. Recalls Langston Dual Lumen Catheter Due to Risk of Separation During Use, Boston Scientific Corporation Recalls Imager II Angiographic Catheters Due to Tip Detachment, LeMaitre Vascular Inc. 1. These products fall under the medical devices legislation and must be CE marked. 2. U.S. Food & Drug Administration ... Medical Device Recalls 1 2 > Results per Page New Search Export to Excel | Help. Learn more about medical device recalls here. 14. 07/10/2020 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Azure XT SR MRI, … A recall is an action taken to address a problem with a medical device that violates FDA law. Healthcare providers or consumers who experience an adverse event after using a Mavidon product should get medical treatment right away. For this article, let’s focus on the products that the FDA pulled from the market. Recalls LeMaitre Over the Wire Embolectomy Catheter Due to Balloon Deflation and Separation Issue, CME America Recalls BodyGuard Infusion Pump System Due to Risk of Over-, and Under-infusion, Medtronic Recalls Pipeline Flex Embolization Devices Due to Risk of Device Fracture, CME America Recalls BodyGuard Microset Infusion Sets for the BodyGuard Infusion Pump System Due to Risk of Under-Infusion, Becton Dickinson (BD) CareFusion 303 Inc. 2020 Recalls So Far. Boston Scientific Medical Device Recall Upgraded to Class I by FDA In Medical Device Recall Posted April 17, 2020 In February 2020, Boston Scientific announced a recall of Imager II 5F Angiographic Catheters. These products are on the list because there is a reasonable chance that they could cause serious health problems or death. Recalls GlideScope Core One TouchSmart Cable (“OneTouch cable”), Due to partial or complete loss of image during use, Arrow International Inc. Medical Device Recall for Medtronic Septostomy Catheters. 02/07/2020. List of Medical Device recalls in 2020. In January 2020, U.S. Rep. Rosa DeLauro (D-CT) reintroduced a bill called the Recall Unsafe Drugs Act, which would grant the FDA the ability to issue a mandatory recall on a drug. A medical device may contain an ancillary medicinal substance to support the proper functioning of the device. We take a look at seven medical devices that have been hit with Class I FDA recalls in the past few years. In total, the FDA approved 48 novel drugs in 2020. The site is secure. Before sharing sensitive information, make sure you're on a federal government site. Product Description. The medical device recall came after the company reported receiving more complaints than usual about the device’s tip becoming detached. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. 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