FDA recall Z-2235-2021

Product

Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X

Reason for recall

The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon.

Distribution

Worldwide distribution - US Nationwide distribution in the states of CA, OH, and the countries of Switzerland, Portugal, and Poland.

Key facts

Status

Terminated

Initiation date

2021-07-19

Report date

2021-08-18

Termination date

2023-02-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami Lakes, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2235-2021