Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter — Class II medical device recall Z-1521-2018

Terminated recall by Cook Inc., reported 2018-05-02, distributed nationwide. Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm balloon label

Recall number	`Z-1521-2018`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Cook Inc., Bloomington, IN, United States
Recall initiated	2018-04-16
Classified	2018-04-25
Reported by FDA	2018-05-02
Terminated	2019-06-27
Distributed	Nationwide (US)
Countries outside the US	PE
Quantity	40 products
Reason classes	labeling
UPC / GTIN / UDI-DI	`10827002522524`, `10827002522647`
Lot numbers	`8426883`, `8429883`
Model numbers	`PTA5-35-135-4-4`, `PTA5-35-135-4-4.0`, `PTA5-35-135-6-2`

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1521-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.