Class II

Medical Device Recall: Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only

Stryker Sustainability Solutions · May 10, 2024

Reason for Recall

Diagnostic electrophysiology (EP) catheters do not meet testing requirements.

Distribution

International distribution to the country of Japan.

Quantity Affected

6 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2268-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.