Z-1514-2024Class II

EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach...

Name: Z-1514-2024 EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach...
Creator: Boston Scientific Corporation
Published: 2024-02-20
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2024-02-20 / Open, Classified / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are... on 2024-02-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1514-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-20
Posted: 2024-04-11
Recalling firm: Boston Scientific Corporation
Product: EndoVive 20Fr Push Standard 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: M00509051
Product code: PIF Gastrointestinal Tubes With Enteral Specific Connectors
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
Root cause tag: manufacturing process
FDA 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 in commerce: 572 units
Distribution: Worldwide distribution - US Nationwide and the country of Japan.
Product codes and lots: GTIN: 08714729880493 Lot Numbers: 32162452, 32370861, 32714500

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1514-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1513-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-17	2024-04-11
Z-1514-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-17	2024-04-11
Z-1515-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-17	2024-04-11
Z-1516-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-17	2024-04-11
Z-1517-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-17	2024-04-11

Product code PIF

K150679Class IIEndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit ConnectorBoston Scientific Corp / cleared 2015-05-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)