CLASS I ONGOING Device recall · Reported 1 Apr 2026 · FDA Enforcement Report
BioFlo DuraMax Catheter recalled by Merit Medical Systems
Merit Medical Systems is recalling BioFlo DuraMax Catheter, distributed nationwide in the US. The recall was initiated on 13 Feb 2026 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1579-2026
- FDA event ID
- 98464
- Recalling firm
- Merit Medical Systems, South Jordan, UT
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 13 Feb 2026
- FDA classified
- 26 Mar 2026
- Reported
- 1 Apr 2026
- Type
- Voluntary: Firm initiated
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 13 Feb 2026 | Recall initiated by company | |
| 26 Mar 2026 | Classified by FDA | +41 days |
| 1 Apr 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/EU, H965103028051/A, H965103028051/EU, H965103028061/A, H965103028061/EU, H965103028070/A, H965103028070/EU, H965103028080/A, H965103028080/EU, H965103028090/A, H965103028090/EU, H965103028161/A, H965103028181/A, H965103028191/A, H965103028191/EU, H965103028201/A, H965103028211/A, H965103028220/A, H965103028230/A, H965103028240/A, H965103038181/A
Where it was distributed
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, NE, WV, OH, MA, MN, CT, MD, KS, WA, TN, ID, UT, DC, MS, IL, OK, AL, RI, AR, NV and OUS (International) to countries of : 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, Georgia, United Kingdom, Brunei Darussalam, Ecuador, Panama, Netherlands, Venezuela, Bolivarian Republic of, Costa Rica, Viet Nam, Cayman Islands, Iran, Islamic Republic of, Australia, Nicaragua, Dominican Republic, Bolivia, Plurinational State of, El Salvador, Guatemala, Honduras, Japan
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichigan
Questions about this recall
Why was it recalled?
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.
Which lots are affected?
REF:UDI-DI/Lot(Expiration): H965103028011/A:00884450793206/I3105589, I3115469, I3314948, I3343030; H965103028021/A:00884450793213/I2985084, I3235297, I3302100, I3343023; H965103028021/EU:00884450840733/I3254932; H965103028031/A:00884450786215/I2890967, I2909607, I2909610, I2909613, I2922255, I2928443, I2928445, I2973185, I2975817, I2979931, I2979932, I3010126, I3015730, I3015731, I3072562, I3108161, I3115487, I3120008, I3156395, I3161825, I3178917, I3202927, I3236144, I3236147, I3236157, I3236162, I3236164, I3368281; H965103028031/EU:00884450835326/I3219447, I3270828, I3288591; H965103028041/A:00884450786253/I2838431, I2910263, I2910264, I2910265, I2973186, I2975804, I2975805, I2979959, I2979960, I3015758, I3064923, I3064925, I3072563, I3108163, I3120003, I3120006, I3156399, I3165147, I3175748, I3178899, I3208677, I3236145, I3236148, I3236158, I3236163, I3236165, I3312321, I3315961, I3323271, I3347039; H965103028041/EU:00884450835333/I3217180, I3270829, I3302439; H965103028051/A:00884450793220/I2929337, I2997999, I3311219; H965103028051/EU:00884450840740/I3219448, I3270832, I3302440; H965103028061/A:00884450793237/I2920321, I2980492, I3154945, I3254911; H965103028061/EU:00884450835340/I3196140, I3270833, I3312332; H965103028070/A:00884450793244/I3015819, I3113237, I3170179, I3247943, I3288616; H965103028070/EU:00884450840757/I3255305, I3307483; H965103028080/A:00884450793251/I3002021, I306492, I3178919, I3302450, I3343031; H965103028080/EU:00884450840764/I3196137, I3302445, I3334625; H965103028090/A:00884450792353/I2920165, I3103138, I3178922, I3290565; H965103028090/EU:00884450840771/I3196135, I3302441, I3352493; H965103028161/A:00884450793268/I2914680, I2980457), I3098578; H965103028181/A:00884450793282/I2890978, I2902665, I2909617, I2909618, I2929338, I3076856, I3085067, I3098579, I3178915, I3254917, I3255301, I3283028; H965103028191/A:00884450793299/H2936911, I2870746, I2908636, I2909637, I2910257, I2920337, I2927199, I3144031, I3164176, I3219662, I3236146, I3288655, I3368110; H965103028191/EU:00884450835371/I3309111; H965103028201/A:00884450793305/I2973187, I3173621, I3178898), I3236149, I3288573; H965103028211/A:00884450793312/I2909764, I3144033, I3302435, I3343037; H965103028220/A:00884450793329/I2909788, I3394016; H965103028230/A:00884450793336/I2982337, I3044847, I3191920, I3288574, I3334623; H965103028240/A:00884450792360/I2929339, I3002035, I3049565, I3108165, I3254923, I3302451; H965103038181/A:00884450786314/I2890952, I2902661, I2902662
Where was it sold?
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, NE, WV, OH, MA, MN, CT, MD, KS, WA, TN, ID, UT, DC, MS, IL, OK, AL, RI, AR, NV and OUS (International) to countries of : 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, Georgia, United Kingdom, Brunei Darussalam, Ecuador, Panama, Netherlands, Venezuela, Bolivarian Republic of, Costa Rica, Viet Nam, Cayman Islands, Iran, Islamic Republic of, Australia, Nicaragua, Dominican Republic, Bolivia, Plurinational State of, El Salvador, Guatemala, Honduras, Japan
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 98464This product is part of a recall event; the main page for the event is CentrosFLO Hemodialysis Catheters recalled by Merit Medical Systems.
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