Merit Medical CentrosFLO Hemodialysis Catheter Recall - Design Defect

FDA: Device Recalls Class I

Filed April 1st, 2026

Detected April 7th, 2026

Summary

FDA issued a Class I recall for Merit Medical CentrosFLO Hemodialysis Catheters due to a design defect in the 16F dual-valved splittable sheath introducer that may not split as intended. The defect may result in hemorrhage, foreign bodies remaining in the patient, and procedure delays. The recall affects multiple product codes and models distributed nationwide across at least 22 states.

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What changed

FDA classified a Class I recall for Merit Medical CentrosFLO Hemodialysis Catheters (Recall Number Z-1575-2026) due to a design defect in the 16F dual-valved splittable sheath introducer. The defect may prevent proper splitting of the introducer, potentially causing hemorrhage, foreign bodies, and procedure delays. Affected products include multiple REF codes across the CENFP and CENFT product lines. The recall involves worldwide distribution with US nationwide coverage to at least 22 states.

Healthcare providers and medical facilities should immediately identify and quarantine all affected CentrosFLO Hemodialysis Catheters in their inventory. Practitioners who have implanted these devices should contact patients for follow-up assessment. Any adverse events associated with these devices must be reported to FDA through MedWatch. Merit Medical Systems, Inc. has initiated the recall, which remains ongoing as of the filing date.

What to do next

Quarantine and stop use of all affected CentrosFLO Hemodialysis Catheter products immediately
Notify all healthcare facilities and practitioners who received the recalled devices
Contact patients who may have received these devices and arrange for clinical follow-up
Report any adverse events or complications associated with these devices to FDA via MedWatch

Source document (simplified)

Merit Medical Systems, Inc.

Device Recalls (Class I)

← All Device Recalls (Class I) Class I Z-1575-2026 · 20260401 · Ongoing

Product

CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A, CENFT19...

Reason for Recall

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.

Distribution

Worldwide distribution: US (nationwide) to states of: TX, LA, OR, NM, MI, FL, CO, CA, GA, NC, AK, NY, PA, WI, NJ, VA, AZ, IN, KY, MO, DE, SC, MT, N...

Source: openFDA Enforcement API