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Due to unsealed portions of pouches.
catheter may experience resistance when being advanced over the guidewire
catheter may experience resistance when being advanced over the guidewire
catheter may experience resistance when being advanced over the guidewire
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.
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.
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.
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.
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.
Inflation device handle may detach from the syringe during procedure.
Merit Medical Systems recalled 173,645 Allwell Inflation Devices on December 4, 2025. The device handle may detach from the syringe during procedures, posing a high hazard. Healthcare providers and patients should stop using the device immediately.
Merit Medical Systems recalled 2,192 units of its Custom Manifold Kit on December 4, 2025. The inflation device handle may detach from the syringe during procedures. This poses a significant risk to patients and healthcare providers.
Inflation device handle may detach from the syringe during procedure.
Merit Medical Systems recalled 18,897 custom inflation kits on December 4, 2025. The inflation device handle may detach from the syringe during use, posing a risk of injury. Healthcare providers and patients should stop using the device immediately.
Inflation device handle may detach from the syringe during procedure.
Inflation device handle may detach from the syringe during procedure.
Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.