Class 2 Device Recall EndoVive One Step Button , Low profile Initial Placement PEG Kit

• Date Initiated by Firm: September 11, 2015
• Date Posted: December 10, 2015
• Recall Status: Terminated on May 17, 2016
• Recall Number: Z-0402-2016
• Recall Event ID: 72364
• 510(K)Number: K910584
• Product Classification: Tube, gastro-enterostomy - Product Code KGC
• Product: One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.
• Code Information: Material Number (UPN) M00563020, Lot # 18184947, Exp. April 30, 2017; Material Number M00563080, Lot # 18179867, Exp. April 30, 2017; & Lot # 18212410 , Exp. May 31, 2017; Material Number M00568510, Lot # 18296155, Exp. May 31, 2018.
• Recalling Firm/ Manufacturer: Boston Scientific Corp; 780 Brookside Dr; Spencer IN 47460-1080
• For Additional Information Contact: Brendan Smith; 763-494-1133
• Manufacturer Reason for Recall: Boston Scientific Corp. initiated a voluntary recall of specific lots of the EndoVive One Step Button, including the Decompression Tube and Low Profile Replacement Button devices because they may contain decompression tube adapters with a protrusion that could impede its ability to be introduced or removed from the PEG Button.
• FDA Determined Cause: Under Investigation by firm
• Action: Boston Scientific Corp. sent an "Urgent Medical Device Recall Removal - Immediate Action Required" letter dated September 10, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If you identify any product from the affected lot within your inventory, please segregate the affected product immediately and return it to Boston Scientific in accordance with the enclosed recall instructions. You will receive replacements for all recalled product that is returned to Boston Scientific. If you are a distributor, or hospital please note that this recall is to the customer level. Please notify any customer who has received affected product. We are notifying affected worldwide regulatory authorities of this Recall Removal as required. Please read carefully through the enclosed Recall Removal Instructions. Your local Sales Representative can answer any questions that you may have regarding this Recall Removal. We regret any inconvenience that this action may cause, and we appreciate your understanding as we take action to ensure patient safety and customer satisfaction. We are committed to continuing to offer products that meet the highest quality standards that you expect from Boston Scientific. Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to Boston Scientific by calling 1-866-868-4004.
• Quantity in Commerce: 22 units
• Distribution: US Distribution to the states of : IN, NV, CA, PA, CT, TN, NY, WI, and WA, and Internationally to Ireland.
• 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.

• 510(K) Database: 510(K)s with Product Code = KGC and Original Applicant = APPLIED MEDICAL TECHNOLOGIES