FDA-Device2026-10-21Class IIPROCESSING DEFECT
Merit Medical Scout MD Delivery System recalled for implantable clip deployment failure
What this means
The implantable clip in Merit Medical's Scout MD Delivery System may not deploy properly during surgery. This could prevent the reflector from working as intended to guide the surgical procedure.
- If you have one of the affected lots (H3515477, H3507786, or H3507794), contact Merit Medical Systems or your healthcare provider immediately.
- Do not use the device if deployment issues are suspected.
- Healthcare facilities should review affected inventory and quarantine recalled lots.
The agency's original wording
Hazard
The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.
Intended for
Adults
Illnesses reported
None reported
Sold states
US: AZ, CA, FL, IN, LA, NV, RI OUS: None
Manufactured in
1600 W Merit Pkwy, South Jordan, UT, United States
Products
Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance System, Rx Only, Sterile-EO
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0187-2027More Merit Medical recalls
- FDA-Device2026-10-07Merit Medical Embosphere microspheres recalled for compromised sterile packaging
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