FDA recall Z-1555-2020

Product

Imager II 5F Angiographic Catheters, 5 units per package.

Reason for recall

Potential for tip detachment of Imager II 5F Angiographic Catheters

Distribution

Worldwide distribution. US nationwide, Australia, Belgium, Brazil, Canada, Switzerland, China, Colombia, Cyprus, Czech Republic, Germany, Spain, Finland, France, Great Britain, Greece, Croatia, Hungary, Indonesia, Israel, India, Italy, Jordan, Japan, South Korea, Lebanon, Lithuania, Mexico, Malaysia, Netherlands, Norway, Poland, Russia, Sweden, Slovakia, Turkey, Taiwan, and South Africa.

Key facts

Status

Ongoing

Initiation date

2020-02-11

Report date

2020-04-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Maple Grove, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1555-2020