Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump… recallZ-2580-2026 · Boston Scientific Corporation · initiated May 11, 2026
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
FDA root cause category: Process control
What the company is doing
Boston Scientific issued an Urgent Medical Device Removal - Immediate Action Required notice to it sole consignee on 5/11/2026 via hand delivery. The notice explained the issue and requested the following: "Instructions: " Immediately stop further use of this specific Intera HAI Pump (S/N 20175). " A Boston Scientific representative will retrieve the impacted device and process the return. " Complete and return the enclosed Reply Verification Tracking Form per the included instructions. " Report any adverse events or quality concerns associated with the use of this device to Boston Scientific via email at [email protected] or FDA s MedWatch Adverse Event Reporting program [www.fda.gov/MedWatch/report.htm or 1.800.FDA.1088 (332.1088)]." The unit was collected by a representative of the firm and subsequently destroyed.
Recall details
- Recall number
- Z-2580-2026
- Status
- Completed
- Initiated by the company
- May 11, 2026
- Posted by the FDA
- Jun 25, 2026
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 1 device
- Product code
- LKK
- FDA submissions
- P890055
- Distribution
- US Nationwide distribution in the state of OH.
Product description
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
Code information (models, lots, serial numbers)
GTIN 00850014110147, Serial Number 20175
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- INTERA AP-03000HIntera Oncology Inc. · Pump, Infusion, Implanted, Programmable2 recalls274 reports
Other devices under the same FDA submission
6 devices cleared under P890055 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- CODMAN AP-03000HCerenovus, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 deaths32 reports
- CODMAN AP-03000LCerenovus, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE17 reports
- NA IP-37957Medos International Sàrl · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE6 reports
- CODMAN AP-03000MCerenovus, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE3 reports
- MEDSTREAM 91-4201USCerenovus, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE3 reports
- CODMAN AP-03000ULCerenovus, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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