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U.S. Department of Health and Human Services

Class 2 Device Recall Gateway OTW 2.75mm x 9mm;

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  Class 2 Device Recall Gateway OTW 2.75mm x 9mm; see related information
Date Initiated by Firm October 22, 2014
Date Posted December 16, 2014
Recall Status1 Terminated 3 on February 12, 2015
Recall Number Z-0482-2015
Recall Event ID 69669
HDE Number H050001 
Product Classification intracranial neurovascular stent - Product Code NJE
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.
Code Information Model M00320072209270, Lot number: 12693091; Exp. Jun 2012.
Recalling Firm/
Manufacturer		 Stryker Neurovascular
47900 Bayside Pkwy
Fremont CA 94538-6515
For Additional Information Contact Gary Rebman
510-413-2263
Manufacturer Reason
for Recall		 Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
FDA Determined
Cause 2		 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: 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.
Quantity in Commerce 1 unit
Distribution US Distribution to the states of: VA, NH, OH and TX.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
HDE Database HDEs with Product Code = NJE and Original Applicant = STRYKER CORP.
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