# FDA recall Z-1521-2018

> **Cook Inc.** · Class II · device recall initiated 2018-04-16.

## Product

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.

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-1521-2018
- **Recalling firm:** Cook Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-16
- **Report date:** 2018-05-02
- **Termination date:** 2019-06-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomington, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1521-2018

## Citation

> AI Analytics. FDA recall Z-1521-2018. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1521-2018. Source: US FDA. Licensed CC0.

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