EndoFLIP EF-322N (UDI 05391530810012)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05391530810012), received between Apr 4, 2019 and Apr 27, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE CATHETER WAS ENTERED INTO THE TRACHEA INSTEAD OF THE ESOPHAGUS. THERE WAS A MINOR BLEEDING. THE CATHETER WAS NEVER FILLED WITH FLUID WHILE INSIDE THE PATIENT. THE PHYSICIAN REALIZED THE LOCATION AND REMOVED THE CATHETER WITHOUT HESI TATION/RESISTANCE. THE STAFF WORKED TO STABILIZE THE PATIENT AND ORDERED CHEST X-RAYS. THE X-RAYS CAME BACK OK AND THE PATIENT WAS CLEARED TO GO HOME. THEY DID NOT MOVE FORWARD WITH THE CASE AND IT WAS CANCELED. THE PATIENT HAD A SUSPECTED SWALLOWING DISORDER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14227316 ↗
• MalfunctionMay 8, 2019Product Quality Problem; Application Program Problem; Product Quality Problem; Application Program Problem

  ACCORDING TO THE REPORTER, WHEN THEY CONNECTED THE CATHETER, THEY RECEIVED AN ERROR MESSAGE "CATHETER NOT SUPPORTED/CATHETER NOT CON ECTED" AND THE SYRINGE HOLDER WAS NOT MOVING TO THE CORRECT POSITION FOR THE CATHETER TO FIT, BUT THERE WAS NO ISSUE WITH THE SYRINGE PLUNGER. IT TOOK THREE CATHETERS TO GET THIS DONE AND THE MACHINE WAS TURNED OFF AND TURNED ON AND THE CATHETER WAS DISCONNECTED AND RECONNECTED TO SEE IF THAT WOULD FIX THE PROBLEM, BUT IT DID NOT. TECHNICAL SUPPORT CONFIRMED THAT THE CATHETER CONNECTOR WAS INSERTED WITH THE GREEN DOTS ALIGNED. THE CATHETER DISPLAY DID NOT HAVE A REAL-TIME CLOCK BATTERY DEPLETED/CMOS ERROR, THERE WAS AN ISSUE WITH ARCHIVING THE DATA, BUT NOT THE CURRENT PROBLEM, AND THE CATHETER WAS NOT DIFFICULT TO REMOVE FROM THE PATIENT. THE CATHETER WILL BE RETURNED FOR INVESTIGATION. THERE WAS NO PATIENT AND USER HARM, BUT THEY REQUIRED ADDITIONAL ANESTHESIA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8593218 ↗
• MalfunctionApr 4, 2019Product Quality Problem; Application Program Problem; Product Quality Problem; Application Program Problem

  ACCORDING TO THE REPORTER, WHEN THEY CONNECTED THE CATHETER, THEY RECEIVED AN ERROR "CATHETER NOT SUPPORTED/CATHETER NOT CONNECTED" AND THE BLACK PIECE THAT LOCKS INTO THE SYRINGE WAS NOT MOVING TO THE CORRECT POSITION TO PROPERLY FIT THE CATHETER. IT TOOK THREE CATHETERS TO GET THE PROBLEM DONE. THE MACHINE WAS TURNED OFF AND ON AND THE CATHETER WAS DISCONNECTED AND RECONNECTED, BUT IT DID NOT FIX THE PROBLEM. TECHNICAL SUPPORT CONFIRMED THAT THE CATHETER CONNECTOR WAS INSERTED WITH THE GREEN DOTS ALIGNED. THERE WAS NO ISSUE WITH THE SYRINGE PLUNGER AND THE CATHETER DISPLAY DID NOT HAVE A REAL-TIME CLOCK BATTERY DEPLETED/CMOS ERROR. THEY HAD AN ISSUE WITH ARCHIVING THE DATA, BUT NOT THE CURRENT PROBLEM, AND THE CATHETER WAS NOT DIFFICULT TO REMOVE FROM THE PATIENT. THERE WAS NO PATIENT AND USER HARM, BUT THEY REQUIRED AN ADDITIONAL ANESTHESIA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8483521 ↗