FDA-Device2026-07-01Class IIPROCESSING DEFECT
Boston Scientific INTERA 3000 Hepatic Artery Infusion Pump recalled for potential drug leakage
What this means
Boston Scientific has recalled one INTERA 3000 Hepatic Artery Infusion Pump (model AP-0300H) due to the potential for leakage along the drug pathway from the pump through the catheter end. This is an implantable device used to deliver medication directly to the liver. The affected device was distributed in Ohio.
- Contact your healthcare provider immediately if you have this device implanted
- Do not attempt to remove or adjust the device yourself
- Ask your provider about whether replacement or repair is needed
The agency's original wording
Hazard
There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the state of OH.
Affected count
1 device
Manufactured in
1 Scimed Pl, N/A, Maple Grove, MN, United States
Products
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2580-2026More Boston Scientific recalls
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- FDA-Device2026-07-29Boston Scientific FARADRIVE Steerable Sheath recalled for air embolism risk from valve damage
- FDA-Device2026-07-29Boston Scientific FARADRIVE Steerable Sheath recalled for air embolism risk from valve damage
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