Z-1153-2024Class II

EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510

Name: Z-1153-2024 EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510
Creator: Boston Scientific Corporation
Published: 2023-12-19
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2023-12-19 / Open, Classified / root cause: labeling and UDI

FDA source

Boston Scientific Corporation began a recall of EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510 on 2023-12-19. FDA classified it as Class II and gives the reason as "Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F. Use of defective product may lead to undersizing the button, which may...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1153-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-19
Posted: 2024-02-16
Recalling firm: Boston Scientific Corporation
Product: EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
Product code: PIF Gastrointestinal Tubes With Enteral Specific Connectors
Reason for recall: Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F. Use of defective product may lead to undersizing the button, which may cause embedding with erosion into the gastric wall, tissue necrosis, infection, sepsis, and associate sequelae.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On December 19, 2024, the firm notified affected customers via URGENT MEDICAL DEVICE PRODUCT REMOVAL letters. Customers were instructed to cease further distribution or use of any remaining affected product. Distributors should forward the notice to their customers to ensure the recall is carried out to the end-user level. Customers were instructed to discontinue use and segregate affected product. Customers will receive a Return Goods Authorization (RGA) number after completing and returning their Reply Verification Tracking Form (RVTF). Customers will receive credit for returned affected product. Reach out to your local Boston Scientific representative with any questions.
Quantity in commerce: 0 US; 74 OUS
Distribution: International distribution to the country of Japan only.
Product codes and lots: UPN M00509500, GTIN (UDI-DI) 08714729902713, Lot 31073152; UPN M00509510, GTIN (UDI-DI) 08714729902720, Lots 31221751, 31761882, 32409573.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1153-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1153-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-16

Product code PIF

K161003Class IIEndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit ConnectorBoston Scientific Corporation / cleared 2016-06-17

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)