Z-1940-2020Class II

Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611...

Name: Z-1940-2020 Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611...
Creator: Cook Inc.
Published: 2020-04-15
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2020-04-15 / Terminated

FDA source

Cook Inc. began a recall of Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611 Balloon-expandable stent made of 316L stainless steel with a... on 2020-04-15. FDA classified it as Class II and gives the reason as "The firm received complaints on five devices from one specific lot where the stent dislodged from the balloon delivery system prior to deployment. Use of affected product may lead to increased procedural time and...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1940-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-15
Posted: 2020-05-08
Terminated: 2024-04-15
Recalling firm: Cook Incorporated
Product: Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611 Balloon-expandable stent made of 316L stainless steel with a slotted tube configuration. It is pre-mounted on an over-the-wire balloon catheter, which serves as the delivery system. The stent is positioned between two radiopaque marker bands, which are located inside the balloon at the proximal and distal tapers of the balloon.
Product code: NIN Stent, Renal
Reason for recall: The firm received complaints on five devices from one specific lot where the stent dislodged from the balloon delivery system prior to deployment. Use of affected product may lead to increased procedural time and additional intervention to remove a stent that dislodged within an unintended location.
FDA root cause: Under Investigation by firm
Action: On April 15, 2020, the firm distributed Urgent Medical Device Recall letters to affected consignees via email. The letter described the product defect and advised that customers do the following: 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all distribution and use of this product. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving the letter. Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return via fax (812.339.7316) or email ([email protected]). 4. The recall notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred. 5. Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: [email protected]. Cook Medical is removing impacted devices from the market. Additionally, an investigation has been opened to determine the appropriate corrective action(s) to prevent reoccurrence of a similar issue.
Quantity in commerce: 10
Distribution: Domestic distribution to OH, IA, VA, and NC. Foreign distribution to Canada.
Product codes and lots: Lot number 10153876

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1940-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1940-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-08

Product code NIN

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)