Z-1521-2018Class II

Advance 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: PTA5-35-135-6-2 .0 and...

Name: Z-1521-2018 Advance 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: PTA5-35-135-6-2 .0 and...
Creator: Cook Inc.
Published: 2018-04-16
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2018-04-16 / Terminated / root cause: labeling and UDI

FDA source

Cook Inc. began a recall of 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... on 2018-04-16. FDA classified it as Class II and gives the reason as "Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm balloon label and vice-versa". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1521-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-16
Posted: 2018-04-25
Terminated: 2019-06-27
Recalling firm: Cook Incorporated
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.
Product code: DQY Catheter, Percutaneous
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On April 16, 2018 Cook Medical Inc. mailed an Urgent Medical Device recall notification to affected customers. Customers were instructed to: 1) Examine your inventory immediately to determine if you have affected product(s), and quarantine affected product(s). Immediately cease all distribution and use of these products; 2) Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. NOTE: Unaffected products that are returned will not be credited; 3) Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return it via fax (812.339.7316) or email ([email protected]); 4) Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time) or by email to [email protected] Cook Incorporated
Quantity in commerce: 40 total products
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
Product codes and lots: Catalog number: PTA5-35-135-6-2 .0 lot 8429883; Catalog number: PTA5-35-135-4-4.0 lot 8426883

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1521-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1521-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-25

Product code DQY

K091527Class IIAdvance 35Lp Low Profile Pta Balloon Dilatation CatheterCook, Inc. / cleared 2009-06-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)