The FDA has posted 16 enforcement recalls of catheter introducer devices since 2025, including 6 Class I (most serious) recalls. Most recent report: Jul 1, 2026.
Potential for thrombus formation during prolonged use of the introducer.
Potential for thrombus formation during prolonged use of the introducer.
Potential for thrombus formation during prolonged use of the introducer.
Potential for thrombus formation during prolonged use of the introducer.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if ster…
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
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 o…
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification.…
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification.…
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification.…
Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device, rather than the packaged 6F version.
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Introducer, Catheter”). Informational only — verify against the FDA before acting.