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

FDA device recall Z-0482-2015 · posted 2014-12-16 · Terminated

Recall details

Recalling firm

Stryker Neurovascular

Reason for recall

Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.

Action taken

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: NeuroComplaints@stryker.com 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.

Root cause

Process control

Status

Terminated

Product code

NJE

Quantity affected

1 unit

Distribution

US Distribution to the states of: VA, NH, OH and TX.

Date initiated

2014-10-22

Date posted

2014-12-16

Date terminated

2015-02-12

Location

Fremont, CA