Merit Medical Systems recalled 47,153 BioFlo DuraMax Catheters distributed worldwide through medical distributors after a design defect in the 16F dual-valved splittable sheath introducer may fail to split as intended. The defect can cause hemorrhage, foreign bodies, and delays in procedures. Clinicians and patients should stop using the device immediately and follow recall instructions from Merit
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: 47,153 units. Distribution: Worldwide. US distribution includes 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. Countries: Canada, Spain, United Arab Emirates, Brazil, Jordan, Iraq, France, Indonesia, Malaysia, Thailand, Slovakia, Colombia, Saudi Arabia, Belize, Hong Kong, Mexico, Austria, Belgium, Chile, Germany, Sweden, Ireland, Poland, Latvia, Italy, South Africa, Switzerland, Bulgaria, Peru, Argentina, Qatar, Greece, United Kingdom, Brunei, Ecuador, Panama,,
A 16F dual-valved splittable sheath introducer may not split as intended during use. This can lead to hemorrhage, foreign bodies in the vascular system, and delays in the planned procedure.
No injuries or incidents have been reported.
1. Stop using the product. 2. Contact Merit Medical Systems or your healthcare provider for instructions. 3. Confirm if your device is part of the recall by comparing REF numbers to the list provided by the manufacturer. 4. Follow the recall instructions for disposal, replacement, or refund as directed by Merit Medical Systems. 5. For refund or replacement information, contact Merit Medical Systems at merit.com or your healthcare provider.
Merit Medical Systems website: https://www.merit.com. FDA recall information: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1579-2026. Hours: Unknown. Phone: Unknown.
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