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Lower risk Medical device recall · FDA · Published May 11, 2026

Boston Scientific Intera 3000 Hepatic Artery Pump Recall: Drug Leakage Risk

Boston Scientific recalls Intera 3000 Hepatic Artery Infusion Pump AP-0300H due to potential drug leakage from the pump through the catheter. Affected units have specific serial numbers and GTIN.

🇺🇸 FDA recall #Z-2580-2026Medical deviceBoston Scientific ›
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Recalling firmBoston Scientific Corporation1 Scimed Pl · Maple Grove, MN 55311-1565
✎ GovInfoNow plain-language explainer

Boston Scientific is recalling the Intera 3000 Hepatic Artery Infusion Pump (AP-0300H) because it may leak medication through the catheter. This could lead to improper drug delivery or exposure to the patient. The recall affects specific units with the serial number 20175 and GTIN 00850014110147. Read more at govinfonow.com/recall/49187-boston-scientific-intera-3000-hepatic-artery-pump-recall-drug-leakage.

Source Summary by GovInfoNow · govinfonow.com/recall/49187-boston-scientific-intera-3000-hepatic-artery-pump-recall-drug-leakage · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2580-2026

Cite this page

“Boston Scientific Intera 3000 Hepatic Artery Pump Recall: Drug Leakage Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49187-boston-scientific-intera-3000-hepatic-artery-pump-recall-drug-leakage. Based on FDA recall #Z-2580-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2580-2026%22&limit=1).

The FDA announced on May 11, 2026, that Boston Scientific Corporation is recalling the Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump due to potential drug leakage. The recall affects devices distributed in Ohio.

How to tell if you have it

  • Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H
  • UPC 00850014110147
  • Serial Number 20175

The hazard

According to the FDA, there is potential for leakage along the drug pathway from the pump through the end of the catheter.

Context

GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Recent recalls include the August 24, 2026 Imager II Angiographic Catheters Recall for tip fracture risk and the August 6, 2026 LUX-Dx Cardiac Monitor System Recall for delayed AF burden alerts. Other recent recalls of similar products include the August 10, 2026 Fresenius Medical Care 5008X HD/HDF with CLiC Blood Tubing Set Recall and the October 29, 2025 B Braun Medical Blood Set Recall.

How to tell if you have this one

Check for the serial number 20175 or GTIN 00850014110147 on the pump. The product is an implantable drug delivery device used for hepatic artery infusion therapy.

  • Brand
    Boston Scientific
  • Product
    Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Number

    Verify the serial number on the pump; affected units have serial number 20175.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution in the state of OH.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 51 days after the firm started it.

1. Firm started the recall: May 11, 202612. FDA classified it Class II: Jun 25, 202623. Published in FDA’s Enforcement Report: Jul 1, 202632026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2580-2026 (May 11, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2580-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA