Class 2 Device Recall EndoVive Safety and Standard 20 Fr Push PEG Kits

• Date Initiated by Firm: February 20, 2024
• Date Posted: April 11, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1515-2024
• Recall Event ID: 94165
• 510(K)Number: K031538
• Product Classification: Tubes, gastrointestinal (and accessories) - Product Code KNT
• Product: EndoVive 20Fr Push Safety PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00566471
• Code Information: GTIN: 08714729802631 Lot Numbers: 32295181 , 32295182 , 32306054 , 32306055 , 32316800 , 32323673 , 32342013 ,32367049 , 32367050 , 32374782 , 32472868 , 32486230 , 32486231 , 32486232 , 32486233 , 32506056 , 32515039 , 32523243 , 32523244 , 32531793 , 32531794 , 32531795 , 33113026 , 33113027 , 33113028 , 33113029 , 33170338
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 100 Boston Scientific Way; Marlborough MA 01752-1234
• For Additional Information Contact: Rebecca KinKead Rubio; 651-581-0761
• Manufacturer Reason for Recall: Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
• FDA Determined Cause: Process design
• Action: Boston Scientific issued Urgent Medical Device Removal letter on 2/20/24 via courier. Letter states reason for recall, health risk and action to take: is readily accessible to all handlers and users of the device. Share this notice with any health care professional within your organization and with any organization where the affected devices may have been transferred. This removal affects only the products listed in Attachment 1 (Affected Products). No other material numbers or batches are impacted by this removal. Further distribution or use of any remaining product affected by this removal should cease immediately. If you are a distributor, this notification must be forwarded to your customers to ensure notification of this product removal is carried out to the end-user level. If you are a facility that has sent products to another hospital or a facility within your network, ensure this notification is forwarded to them. Please read carefully through the Removal Instructions included with this notification. Affected products have been distributed as EndoViveTM Standard Push PEG and EndoViveTM Safety Push PEG Kit. If you are a facility that has received EndoViveTM Safety Push PEG Kits, the full (sealed) procedure kit must be returned. You will not receive credit for opened procedure kits. Your local sales representative can answer any questions you may have regarding this notification. If you have any further questions, please contact your local Boston Scientific sales representative.
• Quantity in Commerce: 2501 units
• Distribution: Worldwide distribution - US Nationwide and the country of Japan.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KNT