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Background Implantable Dopplers (IDs) are widely used for postoperative free flap vascular monitoring. However, IDs may contribute to free flap complications or failure and better understanding of device malfunctions is needed.

Methods The U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience database was queried for all reports of ID adverse events from two leading manufacturers (Cook Vascular and Synovis Life Technologies) in free flap surgery from January 2010 to March 2020. Reports were reviewed and categorized. A comparison of reoperations within select categories was performed using Chi-square analysis.

Results Of 209 included reports, the most common device malfunctions were venous anastomotic coupler misalignment (35.4%) and coupler ring detachment (24.4%). Synovis devices were used in 100% of reports of vessel compression and Cook …