The FDA has posted 7 enforcement recalls of irrigation catheter devices since 2025, none of them Class I (most serious). Most recent report: Apr 15, 2026.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Catheter, Irrigation”). Informational only — verify against the FDA before acting.