FDA recall Z-1685-2022

Product

MEGA 8Fr 50cc Intra-Aortic Balloon Catheter

Reason for recall

Certain lots containing undersized dilator.

Distribution

Awaiting domestic distribution. Foreign: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Iceland, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

Key facts

Status

Ongoing

Initiation date

2022-08-05

Report date

2022-09-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fairfield, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1685-2022