FDA recall Z-2268-2024

Product

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

Reason for recall

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

Distribution

International distribution to the country of Japan.

Key facts

Status

Ongoing

Initiation date

2024-05-10

Report date

2024-07-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Phoenix, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2268-2024