PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: July 10, 2024 Initiated: May 10, 2024 #Z-2268-2024

Product Description

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.

Details

Units Affected
6 units
Distribution
International distribution to the country of Japan.
Location
Phoenix, AZ

Frequently Asked Questions

What product was recalled?
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. Recalled by Stryker Sustainability Solutions. Units affected: 6 units.
Why was this product recalled?
Diagnostic electrophysiology (EP) catheters do not meet testing requirements.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 10, 2024. Severity: Moderate. Recall number: Z-2268-2024.