FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: EndoVive 20Fr Push Safety PEG Kit w/ENFit (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: M00509011
- Recall number
- Z-1513-2024
- Recalling firm
- Boston Scientific Corporation
- Product
- EndoVive 20Fr Push Safety PEG Kit w/ENFit (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: M00509011
- Status
- Open, Classified
- Initiated
- 2024-02-20
- Posted
- 2024-04-11
- Terminated
- not on file
- Reason
- 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
- 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
- 2726 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Japan.
- Lot, serial or model codes
- GTIN: 08714729880417 Lot Numbers: 32257549, 32257552, 32267521, 32270820, 32358475, 32358478, 32367048, 32374780, 32374781, 32385061, 32506053, 32506054, 32515036, 32531791, 32545183, 32545184, 32623024, 32802227, 32802228, 32810934, 32810935, 32958981, 32958982 ,32968819, 32970723, 33080372,33080373,33087966 ,33209008
- 510(k) numbers
- ["K150679"]
- PMA numbers
- not on file
- Product code
- PIF
- Firm FEI
- 3005099803
- Firm city
- Marlborough
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28