Merit Medical Systems has issued an active recall affecting 35,591 CentrosFLO Hemodialysis Catheters sold worldwide. The recall centers on a 16F dual-valved splittable sheath introducer that may fail to split as intended. This failure can cause hemorrhage, foreign-body retention, and procedure delays. Healthcare providers should stop using the device and follow Merit Medical's recall instructions.
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, and procedure delay.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Merit Medical Systems, Inc. or your healthcare provider for instructions
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Quantity recalled: 35,591 units. Distribution: Worldwide; US distribution to multiple states listed; international distribution to Canada, Spain, United Arab Emirates, Brazil, and more. Recall date: 2026-02-13. Report date: 2026-04-01. Brand: Merit Medical Systems. Product: CentrosFLO Hemodialysis Catheters with 16F dual-valved splittable sheath introducer (REFs listed) and related lot/UDI identifiers.
The 16F dual-valved splittable sheath introducer has a design defect that may prevent the sheath from splitting as intended during use. This can lead to hemorrhage, retained foreign bodies, and delays in the dialysis procedure.
No injuries or incidents have been reported.
1. Stop using the product immediately. 2. Follow the recall instructions provided by Merit Medical Systems or your healthcare provider. 3. Contact Merit Medical Systems or your healthcare supplier for instructions on next steps and potential replacement or refund.
Recall page and official information accessible via the FDA enforcement report at the provided recall URL. Direct Merit Medical contact details are not included in the data provided.
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