Z-2580-2026 Class II
FDA device recall Z-2580-2026 was initiated by Boston Scientific Corporation on May 11, 2026 and is designated Class II. Reason for recall: There is the potential for leakage along the drug pathway from the pump through the end of the catheter. Affected quantity: 1 device.
Recall Details
- Product Type
- Devices
- Report Date
- July 1, 2026
- Initiation Date
- May 11, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 device
Product Description
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
Reason for Recall
There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
Distribution Pattern
US Nationwide distribution in the state of OH.
Code Information
GTIN 00850014110147, Serial Number 20175