Cordis Corporation: Medical Device Recall in 2021 - (Recall #: Z-2235-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 19, 2021

Date Posted: August 18, 2021

Recall Number: Z-2235-2021

Event ID: 88348

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.

Status: Terminated

Product Quantity: 8 units

Code Information:

Lot/Batch number 82219442

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated