Merit Medical

Merit Medical Systems' Splashwire Hydrophilic Guide Wire — used by doctors in vascular procedures — has been recalled because some product pouches were not sealed properly. Unsealed pouches can allow contamination or damage to the sterile device before use.

Merit Medical Systems is recalling certain BioFlo DuraMax Catheters because the sheath introducer may not split as designed. This defect could lead to complications during medical procedures, including bleeding, blood clots, or difficulty removing the catheter.

Merit Medical Systems is recalling certain DuraMax chronic hemodialysis catheters due to a design defect in the 16F dual-valved splittable sheath introducer. The sheath may not split properly during insertion, which could cause bleeding, blood clots, catheter malfunction, or loss of future vascular access.

Merit Medical Systems is recalling specific lots of its 16F dual-valved splittable sheath introducer because of a design defect that may prevent it from splitting properly during use. This could lead to serious complications including bleeding, blood clots, or damage to blood vessels.

Merit Medical Systems is recalling certain ProGuide Chronic Dialysis Catheters with a 16F dual-valved splittable sheath introducer due to a design defect. The sheath may not split as intended during insertion, which could cause serious complications including bleeding, blood clots, or damage to blood vessels.

Merit Medical Systems is recalling certain CentrosFLO hemodialysis catheters because the introducer sheath may not split properly during placement. This design defect could lead to bleeding, blockages, or difficulty placing the catheter correctly.

Merit Medical Systems is recalling certain Allwell Angioplasty Packs because the inflation device handle may detach from the syringe during a procedure. This could interrupt treatment and require the procedure to be stopped or repeated. No injuries have been reported.

Merit Medical Systems is recalling certain Custom Procedure Kits because the inflation device handle may detach from the syringe during a medical procedure. This could interrupt the procedure or cause other complications. No injuries have been reported.

Merit Medical Systems is recalling its Custom Manifold Kit (model K09-13203A) because the inflation device handle may detach from the syringe during a medical procedure. This could interrupt treatment or require procedure restart. No injuries have been reported.

Merit Medical Systems is recalling multiple Custom Inflation Kit models because the handle may detach from the syringe during use. This could interrupt a medical procedure. No injuries have been reported so far.

Merit Medical Systems is recalling specific lots of their Custom Waste Management Kit Vascular Tray because the inflation device handle may detach from the syringe during a medical procedure. This could interrupt patient care. No injuries have been reported.

Merit Medical Systems is recalling the Allwell Inflation Device (model IS-30-A) used in angiographic procedures because the handle may detach from the syringe during use. This could compromise the procedure and patient safety. The recall affects specific lot numbers distributed worldwide.

Merit Medical Systems' basixCOMPAK inflation device handle may detach from the syringe during a medical procedure. This affects multiple reference numbers and lots of the 20 mL, 30 atm/bar model used in clinical settings.

Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.