Z-1516-2024 Class II Ongoing
FDA device recall Z-1516-2024 was initiated by Boston Scientific Corporation on Feb 20, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 1475 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 17, 2024
- Initiation Date
- Feb 20, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1475 units
Product Description
EndoVive 20Fr Push Standard 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: M00568211
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
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Japan.
Code Information
GTIN: 08714729285205 Lot Numbers: 32151880, 32247311, 32810232
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1516-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026