EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOF

FDA device recall Z-2950-2026 · posted 2026-08-14 · Open, Classified

Recall details

Recalling firm

Covidien, LLC

Reason for recall

Due to products are incorrectly flagged as expired due to the system's 24-hour usage limit, rendering the product unavailable for clinical procedures.

Action taken

On 05/13/2026, an "URGENT: MEDICAL DEVICE CORRECTION" letter was emailed/mailed to inform customer that EF-100 modules are affected by an end-of-life (EOL) software issue that prevents the units from recognizing Endoflip and Esoflip catheters after 01-January-2026, causing them to appear as expired. On 07/145/2026, an "Update to Urgent: Medical Device Correction" letter was sent via UPS 2-Day delivery updated potential patient harms Customers are instructed that: "May use the EF-300 system, if they have one. It is recommended to consult their biomedical staff for assistance in adjusting the internal clock. Instructions for this process are enclosed with this notification. As the product has reached end-of-life and end-of-service, Medtronic Technical Services is unable to assist in resetting the internal clock. The user is advised that effects of the data change workaround are seen in exported files. When a USB drive is inserted into the EF-100 system, the SAVE button is enabled to record raw data. For each procedure, a folder is generated and is automatically deleted when the next procedure begins. The folder name includes the Patient ID, the date (YYMMDD format), and the time (HH:MM). All files generated within this folder include the Patient ID in their filenames. The live data file contains raw data with time stamps. These timestamps will reflect the system date, which, under the Date Change Workaround, will be set to 2020. "Post this notice in all care environments where the affected products are used, to maintain awareness to this issue. "Share this notice with all relevant personnel within your organization, and with any organization to which the affected product listed in the Product Information table above has been transferred or distributed. "Complete and return the enclosed Customer Confirmation Form to [insert e-mail], even if you do not have any affected product in your inventory, to acknowledge that you have read and understand this letter.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

FFX

Quantity affected

327

Distribution

Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN,

Date initiated

2026-05-13

Date posted

2026-08-14

Location

Santa Clara, CA

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