FDA Enforcement
Class II
Ongoing
EndoVive 20 Fr Safety PEG Push w/ENFit 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: M00509191
Recall: Z-1517-2024
·
Reported April 17, 2024
Enforcement
- Recall Number
- Z-1517-2024
- Event ID
- 94165
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Boston Scientific Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 17, 2024
- Initiation Date
- February 20, 2024
- Classification Date
- April 11, 2024
- Address
- 100 Boston Scientific Way, N/A, Marlborough, MA, 01752-1234, United States
Description
EndoVive 20 Fr Safety PEG Push w/ENFit 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: M00509191
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
Code Info
GTIN: 08714729880691 Lot Numbers: 32234291
Distribution
Worldwide distribution - US Nationwide and the country of Japan.
Quantity
13 units (Japan)