—#206499

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

FDA product code: KNT — Tubes, Gastrointestinal (And Accessories)
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K031538
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the country of Japan.

Timeline

Recall initiated: 2024-02-20
Posted by FDA: 2024-04-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206499. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.