FDA recall Z-0467-2019

Stryker Sustainability Solutions · Class II · device

Product

Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.

Reason for recall

Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for reprocessing.

Distribution

US: KS OUS: None

Key facts

Status
Terminated
Initiation date
2018-08-23
Report date
2018-11-21
Termination date
2021-02-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tempe, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0467-2019