The FDA has posted 36 enforcement recalls of reprocessed electrode recording catheter devices since 2025, including 9 Class I (most serious) recalls. Most recent report: Jul 8, 2026.
Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of…
Incomplete seals on sterile product
Incomplete seals on sterile product
Incomplete seals on sterile product
Incomplete seals on sterile product
Incomplete seals on sterile product
Incomplete seals on sterile product
Incomplete seals on sterile product
Incomplete seals on sterile product
Incomplete seals on sterile product
Incomplete seals on sterile product
Incomplete seals on sterile product
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Catheter, Recording, Electrode, Reprocessed”). Informational only — verify against the FDA before acting.