C.R. Bard, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0405-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Bard Inlay Optima¿ Multi-Length Ureteral Stent Coated Double Pigtail Ureteral Stent with Stent and Multi- Length Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.

Product Classification:

Class II

Date Initiated: October 13, 2016

Date Posted: November 23, 2016

Recall Number: Z-0405-2017

Event ID: 75492

Reason for Recall:

Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.

Status: Terminated

Product Quantity: 75,089 units

Code Information:

Product Codes: 777400, 777600, 777700, 777800, 778400, 778600, 778700, 778800, 786400, 786600, 786700,786800, 787400, 787600, 787700, 787800, 788400, 788600, 788700 and 788800.

Distribution Pattern:

U.S. Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated