Cook Inc.: Medical Device Recall in 2018 - (Recall #: Z-1521-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: PTA5-35-135-6-2 .0 and PTA5-35-135-4-4 .0; UDI: 10827002522647 and 10827002522524 Product Usage: The Advance¿ 35LP Low Profile PTA Balloon Dilation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Product Classification:

Class II

Date Initiated: April 16, 2018

Date Posted: May 2, 2018

Recall Number: Z-1521-2018

Event ID: 79861

Reason for Recall:

Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm balloon label and vice-versa.

Status: Terminated

Product Quantity: 40 total products

Code Information:

Catalog number: PTA5-35-135-6-2 .0 lot 8429883; Catalog number: PTA5-35-135-4-4.0 lot 8426883

Distribution Pattern:

Worldwide Distribution - US Nationwide in the states of AZ, DE, FL, GA, ID, IL, KY, MI, MO, NH, NJ, PA, RI, TX, UT and the country of Peru

Voluntary or Mandated:

Voluntary: Firm initiated