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MEDWATCH: THE FDA SAFETY INFORMATION AND ADVERSE EVENT REPORTING PROGRAM

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MedWatch, the FDA’s medical product safety reporting program for health
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MedWatch receives reports from the public and when appropriate, publishes safety
alerts for FDA-regulated products such as:

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Search Showing 1 to 10 of 661 entries


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Year 20242023202220212020201920182017
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DateSafety AlertProduct Type 08/28/2024Tandem Diabetes Care, Inc. Recalls
Version 2.7 of the Apple iOS t:connect Mobile App Used in Conjunction with
t:slim X2 Insulin Pump with Control-IQ Technology Prompted by a Software Problem
Leading to Pump Battery DepletionMedical Devices08/26/20242023 Safety
CommunicationsMedical Devices, Radiation-Emitting Products08/26/2024Voluntary
Recall of SoClean Equipment Intended for Use with CPAP Devices and Accessories:
FDA Safety CommunicationMedical Devices08/23/20242024 Medical Device
RecallsMedical Devices, Radiation-Emitting Products08/23/2024Clot Removal Device
Correction: Inari Medical Updates Use Instructions for ClotTriever XL Catheter
due to Reports of Patient Injury and Death from Device Entrapment and Pulmonary
Emboli Medical Devices08/23/2024Convenience Kit Component Recall: Medline
Industries, LP, Removes Convenience Kit Syringes Manufactured in China that May
Be Contaminated, Break, Leak, or Otherwise Fail Medical Devices08/22/2024Chest
Compression Device Recall: Defibtech, LLC, Removes RMU-2000 ARM XR Chest
Compression Device due to Risk of Device Stopping Compressions Medical
Devices08/20/2024Infusion Pump Battery Correction: ICU Medical Updates
Instructions for Use Regarding Batteries in Plum 360, A+ and A+3 Infusion System
due to Diminished Battery Life that May Impact Infusion Delivery Medical
Devices08/16/20242024 Safety CommunicationsMedical Devices, Radiation-Emitting
Products08/16/2024UPDATE: Evaluating Plastic Syringes Made in China for
Potential Device Failures: FDA Safety CommunicationMedical Devices

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