Merit Medical Systems, Inc. is recalling approximately 472,730 medical devices, including various CentrosFLO, ProGuide, DuraMax, and BioFlo DuraMax catheters, as well as standalone sheath introducers. The 16F dual-valved splittable sheath introducer contains a design defect that may prevent it from splitting as intended during medical procedures. This defect can lead to serious complications such as severe bleeding, foreign bodies left in the patient, procedure delays, blood clots, and impaired catheter function. These devices were distributed worldwide between February 2023 and February 2026.
The sheath may fail to split during the catheter insertion process, which can cause vessel damage, hemorrhage, or the creation of fragments (foreign bodies) that may enter the bloodstream and cause an embolism or thrombosis.
Recall number Z-1575-2026.
Recall number Z-1576-2026.
Recall number Z-1577-2026.
Recall number Z-1578-2026.
Recall number Z-1579-2026.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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