Z-0482-2015Class II

Gateway OTW 2.75mm x 9mm; The Gateway PTA balloon catheter is indicated for balloon dilation of the stenotic...

Name: Z-0482-2015 Gateway OTW 2.75mm x 9mm; The Gateway PTA balloon catheter is indicated for balloon dilation of the stenotic...
Creator: Stryker Neurovascular
Published: 2014-10-22
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2014-10-22 / Terminated / root cause: manufacturing process

FDA source

Stryker Neurovascular began a recall of Gateway OTW 2.75mm x 9mm; The Gateway PTA balloon catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries for the purpose... on 2014-10-22. FDA classified it as Class II and gives the reason as "Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0482-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-22
Posted: 2014-12-16
Terminated: 2015-02-12
Recalling firm: Stryker Corp.
Product: Gateway OTW 2.75mm x 9mm; The Gateway PTA balloon catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries for the purpose of improving intracranial perfusion.
Product code: NJE Intracranial Neurovascular Stent
Reason for recall: Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Stryker Neurovascular sent an Urgent Medical Device Recall Notification dated October 22, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Letters request that users take the following actions: 1. Immediately locate the subject devices and quarantine them. 2. Distribute this notice to all affected Departments in your facility. 3. Inform Stryker Neurovascular if any of the subject devices have been distributed to other organizations. a. Please provide contact details so that Stryker Neurovascular can inform those recipients appropriately. 4. Complete and sign the attached Customer Response Form and: a. Fax it to: 1-866-876-4355 or b. E-mail a copy to: [email protected] c. Please complete this form even if you do not have any subject devices to return to prevent the need of follow up notices. 5. Keep a copy of the completed, signed Customer Response Form for your records. Stryker Customer Service reps will contact customers to arrange for replacement. Any returned product will be quarantined and destroyed.
Quantity in commerce: 1 unit
Distribution: US Distribution to the states of: VA, NH, OH and TX.
Product codes and lots: Model M00320072209270, Lot number: 12693091; Exp. Jun 2012.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0482-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0478-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-10	2014-11-28
Z-0479-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-10	2014-11-28
Z-0480-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-10	2014-11-28
Z-0481-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-10	2014-11-28
Z-0482-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-10	2014-11-28

Product code NJE

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)