FDA recall Z-1846-2020

Product

Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414; A4E03/(01)00607915113421; A4E04/(01)00607915113438; A4E05/(01)00607915113445; A4E06/(01)00607915113452; A4E08/(01)00607915113476; A4E09/(01)00607915113483

Reason for recall

The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.

Distribution

Worldwide distribution - United States: Nationwide OUS: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, Poland, Saudi Arabia, South Africa, Spain, Taiwan, United Kingdom

Key facts

Status

Terminated

Initiation date

2019-10-24

Report date

2020-05-13

Termination date

2023-06-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rancho Santa Margarita, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1846-2020