Medical Device Problems

To continue the fight for #PatientsOverProfits, we are handing the reins of @bleedingedgedoc social media accounts to the activists behind Medical Device Problems. See the image for a message from The Bleeding Edge filmmakers.

Medicare has different standards than the FDA. That’s how it should be. trib.al/12Fab3k

The troubles with 510(k)-cleared Profemur hip implants continue. This is a prime example of why 510(k) clearance should be a LIMITED EXCEPTION, not a rule for implantable devices! @US_FDA @FDADeviceInfo kffhealthnews.org/news/article/p…

What fresh hell is this, asking patients TO MONITOR A #MEDICALDEVICE THEY USE WHILE SLEEPING for overheating/fire?! Add a smoke detector on your CPAP machine, I guess? Why do we have an #FDA? This is embarrassing, y'all. #DoTheRightThing?

More modifications to high risk devices = more recalls of those devices. Who would've guessed THAT? 🙄 ~10% of U.S. residents will have #medicaldevices implanted during their lifetime, and physicians should be aware of this association! #patientsafety medpagetoday.com/publichealthpo…

AdvaMed spent 4 yrs lobbying against restrictions on ethylene oxide, stating it's "too hard" to find alternatives. So the industry you defend as masters of rapid innovation CAN'T innovate when it comes to safety, only when it comes to profits? Uh-uh... #FAIL #medicaldevices #FDA

EPA proposes limits to a carcinogen used to sterilize #medicaldevices while FDA encourages alternatives. Meanwhile, @AdvaMedUpdate CEO Scott Whitaker INSISTS many medical devices “simply cannot” be sterilized by another method. statnews.com/2023/04/11/eth…

Did you know companies aren't required to provide a full list of the materials in their #medicaldevices? We think this is wrong! If you have new-onset problems after being implanted w/ a device, consider LTT testing like @MELISA_test for these metals & alloys.

The #FDA stated on Thursday that several Exactech joint replacement #medicaldevices were packaged in defective bags. Patients are recommended to contact their healthcare providers about any pain, swelling, weakness, grinding, noise, etc. #patientsafety medpagetoday.com/orthopedics/or…

Thanks to @WRAL for this segment on the struggles for women who need to have recalled #breastimplants removed, but why no mention of the recent @US_FDA statement regarding the risks of OTHER types of cancers due to these #medicaldevices? @AbbVie wral.com/women-struggle…

Ah, yes, good ol' @Medtronic, up to their usual #DirtyDeeds with complicit doctors to perform unnecessary procedures so they can sell #medicaldevices that cost $15,000 each and experiment on unwitting low-income minority patient populations. #PatientSafey latimes.com/business/story…

For those of you that have received an implanted medical device, did you receive an implant card which listed your device’s unique device identifier? The UDI acts almost like the VIN on your vehicle and is used to relay important recall information.

Urgent Voluntary Recall: 🚨 On January 5, 2022, CorneaGen discovered that Cornea Patch Grafts were obtained from a donor who tested reactive for HIV-1/HIV-2 Plus O antibody and were shipped prior to being medically cleared. fda.gov/vaccines-blood…

Recall Notice 🚨 Arrow International, LLC (Subsidiary of Teleflex Inc.) Recalls the Arrow-Trerotola Percutaneous Thrombolytic Device Due to Risk of Tip Damage During Use fda.gov/medical-device…

Leadless Pacing Systems: Risk of Major Complications Related to Cardiac Perforation During Implantation - Letter to Health Care Providers fda.gov/medical-device…

Recall Notice 🚨 DeRoyal Industries, Inc. Recalls Procedure Packs Containing Smiths Medical NORMOFLO Irrigation Warming Set Due to the Possibility of Harmful Levels of Aluminum Leaching into the Fluid Path of the Warmers fda.gov/medical-device…

Recall Notice 🚨 Medtronic Recalls MiniMed Insulin Pumps for Incorrect Insulin Dosing fda.gov/medical-device…

Recall Notice 🚨 Magellan Diagnostics Recalls LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests Due to Risk of Falsely Low Results fda.gov/medical-device…

Left Atrial Appendage Occlusion (LAAO) Devices Potentially Associated with Procedural Outcome Differences Between Women and Men (Watchman Device) – Letter to Health Care Providers fda.gov/medical-device…

Recall Notice 🚨 Armstrong Medical Limited Recalls AMSORB PLUS PREFILLED G-CAN 1.0L Due to Reduced Gas Flow to Patients During Anesthesia fda.gov/medical-device…