Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Ca

FDA device recall Z-1641-2025 · posted 2025-04-21 · Open, Classified

Recall details

Recalling firm

Merit Medical Systems, Inc.

Reason for recall

Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.

Action taken

On March 14, 2025, Merit Medical issued a "Urgent Medical Device Recall Notice via E-Mail, followed by mail to affected consignees. Merit asked consignees to take the following actions: 1. Read and understand this communication and the updated IFU referenced in the attached poster. 2. There is no need to return product to Merit. 3. Post the attached poster on or near the affected products so users are aware of the updated IFU. 4. Discard the current IFU with the product at point of use. 5. Ensure that applicable personnel within your organization are made aware of this communication. 6. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them. 7. If you require paper IFUs, please contact RESPONSE@merit.com. 8. Please acknowledging you are aware of the information communicated and have completed the actions required of you. 9. If you require additional product training regarding the IFU updates, please contact your Merit Sales Representative to schedule.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

ODE

Quantity affected

7453 units

Distribution

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR

Date initiated

2025-03-14

Date posted

2025-04-21

Location

South Jordan, UT

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