Merit Medical Systems Recalls BioFlo Dialysis Catheter Components Due to Design Defect

What Happened

Merit Medical Systems Inc. has initiated a voluntary recall of the 16F Dual-valved Splittable Sheath Introducer due to a design defect. The company has identified that the sheath introducer may not split as intended during use. This specific component is utilized in several finished medical devices, including the BioFlo DuraMax and BioFlo Dialysis Catheter with Endexo Technology.

Merit has received customer complaints regarding this issue, including reports of patient injury. If the sheath introducer fails to split correctly, it can lead to serious medical complications such as hemorrhage, the introduction of foreign bodies into the patient, and significant procedure delays.

Which Products Are Affected

The recall affects all lots of the BioFlo Dialysis Catheter With Endexo Technology. The following model/catalogue numbers are included in this action:

• H965103028041
• H965103028051
• H965103028061
• H965103028070
• H965103028090
• H965103028080
• H965103028031

What You Should Do

Merit Medical Systems is requesting that all customers immediately discontinue the use of the 16F dual-valved splittable sheath introducer. The affected sheath introducers should be destroyed at the point of use.

Note that other products included within the catheter kits, aside from the specific sheath introducer, may continue to be used according to the manufacturer’s instructions.

Why This Matters

This recall is significant because the defect poses a direct risk of physical injury and hemorrhage to patients undergoing dialysis catheter placement. The reported injuries and the potential for foreign bodies to remain in the patient necessitate immediate corrective action by medical facilities.

Source

Health Canada Recall Alert