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. Please be aware, this recall is a voluntary correction, not a product removal. Recalled Product Product Names and Product Codes: Impella 5.0 Blood Pump, Product Number 005062 Impella CP…
Abbott Recalls Amplatzer Steerable Delivery Sheath for Increased Risk of Air Embolism
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 Product Name: Amplatzer Steerable Delivery Sheath Product Model: ASDS-14F-075 Distribution Dates: October 4, 2022 to February 22, 2023 Devices Recalled in the U.S.: 672 Date Initiated by…
Do Not Use RoyalVibe Health, CellQuicken, or Well-Being Reality Ultrasound Medical Devices: FDA Safety Communication
Date Issued: July 17, 2023 The U.S. Food and Drug Administration (FDA) is warning consumers not to use ultrasound medical devices manufactured and distributed by RoyalVibe Health, CellQuicken, or Well-Being Reality. The devices have not been reviewed by the FDA. The safety and effectiveness of these devices have not been established to diagnose, treat, or…
Use Alternative Testing Method for the Quidel Cardiovascular Inc. Quidel Triage Cardiac Panel – Letter to Health Care Providers
July 19, 2023 The U.S. Food and Drug Administration (FDA) is recommending health care providers, laboratory personnel, and facilities stop using the Quidel Triage Cardiac Panel, manufactured by Quidel Cardiovascular Inc. (QuidelOrtho). On May 25, 2023, QuidelOrtho issued an Urgent Product Correction Notification to customers in which they recalled certain lots of the Quidel Triage…
Medtronic Recalls Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) with Glassed Feedthrough for Risk of Low or No Energy Output During High Voltage Therapy
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 Product Names: Cobalt XT, Cobalt, Crome ICDs and CRT-Ds Claria MRI, Amplia MRI, Compia MRI, Viva, Brava CRT-Ds Visia AF, Visia AF MRI, Evera, Evera MRI, Primo…
Quidel Cardiovascular Inc. Recalls Quidel Triage Cardiac Panels for Risk of False Negative Troponin Results that Could Cause Delayed Diagnosis or Missed Myocardial Infarction
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 Product Names: Quidel Triage Cardiac Panel Quidel Triage Cardiac Panel, Troponin I Quidel Triage Cardiac Panel, CK-MB and Troponin I Product Codes: 97000HS 97021HS 97022HS Product Lots:…
NOxBOX Ltd. Recalls NOxBOXi Nitric Oxide System for Manifold Failure that May Cause Gas Leaks and Interrupt Therapy to Neonates
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 Product Names: NOxBOXi Nitric Oxide Delivery System Product Serial Numbers: See Recall Database Entry Distribution Dates: May 21, 2021 to February 27, 2023 Devices Recalled in the…
Draeger Medical Recalls Oxylog 3000 Plus Emergency and Transport Ventilators for Risk of Unexpected Depleted Battery and Ventilator Stop
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 Product Names: Oxylog 3000 Plus Emergency and Transport Ventilator Part Numbers: 5704811 and 5704813 Product Material Numbers: See Recall Database Entry Distribution Dates: April 30, 2012 to…
Megadyne Recalls MEGA 2000 and MEGA Soft Reusable Patient Return Electrodes for Risk of Serious Burn Injuries to Patients
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 Product Names and Codes: Devices Recalled in the U.S.: 21,200 Dates Distributed: March 11, 2021 – May 9, 2023 Date Initiated by Firm: June 1, 2023 Device…
UPDATE: Paclitaxel-Coated Devices to Treat Peripheral Arterial Disease Unlikely to Increase Risk of Mortality – Letter to Health Care Providers
July 11, 2023 The U.S. Food and Drug Administration (FDA) is informing health care providers about updated information associated with paclitaxel-coated devices used to treat peripheral arterial disease (PAD). Based on the FDA’s review of the totality of the available data and analyses, we have determined that the data does not support an excess mortality…