Merit Medical Systems recalled 21,591 DuraMax chronic hemodialysis catheters worldwide. The devices use a 16F dual-valved splittable sheath introducer that may not split as intended, risking hemorrhage and procedure delays. Clinicians should stop using the devices immediately and follow the 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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The DuraMax Chronic Hemodialysis Catheter is a long-term vascular access device used in dialysis. It includes a 16F sheath introducer that may be splittable for catheter placement.
If the sheath does not split as designed, it can cause hemorrhage, leave foreign material in the patient, or delay a dialysis procedure.
This recall is not presented as part of a broader industry pattern in the available data.
Clinicians and patients may face procedure delays and potential surgical complications. A prompt stop-use and recall follow-through are essential.
On device labels, packaging, hospital procurement documents, and the FDA recall page linked in the notice.
Refunds or replacements typically complete within 4-8 weeks after qualification and authorization.
Keep photos of the device label, packaging, and recall notice. Save correspondence with Merit Medical and hospital procurement.
REF numbers: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H787103028051/A, H787103028055/A, H787103028061/A, H787103028075/A, H787103028085/A, H787103028095/A, H787103028165/A, H787103028181/A, H787103028185/A, H787103028191/A, H787103028195/A, H787103028205/A, H787103028215/A, H787103028225/A, H787103028235/A. Distribution: Worldwide. United States states listed include TX, LA, OR, NM, MI, FL, CO, CA, GA, NC, AK, NY, PA, WI, NJ, VA, AZ, IN, KY, MO, DE, SC, MT, NE, WV, OH, MA, MN, CT, MD, KS, WA, TN, ID, UT, DC, MS, IL, OK, AL, RI, AR,NV
No injuries or incidents have been reported.
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