Medical Device Recall Case Study

Medical Device Recalls | FDA

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls

The FDA posts summaries of information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health...

Recalls, Corrections and Removals (Devices) | FDA

https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices

Seven serious medical device failures that have led to urgent …

https://www.nsmedicaldevices.com/analysis/medical-device-failures-fda-recalls/

Anatomy of a medical device recall: How defective …

https://www.medtechdive.com/news/medical-device-recall-process-fda-philips-medtronic/608205/

Medical device recalls require speed to ensure patient safety. But the system used to pull defective products with potential risk of serious injury or death is clunky and …

Regulatory Control on Medical Devices -A Case Study …

https://www.researchgate.net/publication/361691254_Regulatory_Control_on_Medical_Devices_-A_Case_Study_on_Device_Recalls_by_USFDA

Further, a case study was performed to identify the medical devices that were recalled in the year 2020, to investigate the reason for the recall, the subsequent effects …

Recalled Medical Devices Fast-Tracked Through FDA Approval …

https://www.aboutlawsuits.com/510k-fda-approval-recall-study/

Recalled Medical Devices Fast-Tracked Through FDA Approval Process Were Often Based on Flawed, Older Designs: Study Many recalled medical devices, …

The Hidden Cost of a Product Recall

https://hbswk.hbs.edu/item/the-hidden-cost-of-a-product-recall

A recall can delay a company’s incremental innovations by six months. Medtech product development teams typically focus on a single product category or line, allowing them to apply their …

Recall of a Class I Medical Device: A …

https://publicsafetyandvigilance.com/2020/04/recall-of-a-class-i-medical-device-a-most-serious-type-recall/

On 10 Mar 2020, the firm LeMaitre Vascular, Inc. has initiated an “Urgent medical device recall” for their product “LeMaitre 5F Plus Over the Wire Embolectomy Catheter” (510(k) number: …

Device Recall Case Study - [PPT Powerpoint] - vdocuments.net

https://vdocuments.net/device-recall-case-study.html

S. Waldman MECH 393 Medical Device Recall Case Study The objective of this lecture is to examine one of the many medical device recalls that have occurred …

Case Study: How is My Medical Device Classified?

https://www.fda.gov/media/131272/download

Case Study: How is My Medical Device Classified? Classes of Medical Devices *3% of devices are Unclassified Learning Objective Describe how to approach …