FDA recall Z-3020-2018

Product

Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090, M003WE0250150, M003WE0300150, M003WE0350150, M003WE0400150, M003WE0450150, M003WE0250200, M003WE0300200, M003WE0350200, M003WE0400200, M003WE0450200

Reason for recall

Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported

Distribution

China

Key facts

Status

Terminated

Initiation date

2018-06-05

Report date

2018-09-19

Termination date

2020-11-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fremont, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3020-2018