CLASS II Device recall · Reported 1 Jul 2026 · FDA Enforcement Report
Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled
Boston Scientific is recalling Intera Oncology Intera 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug, distributed nationwide in the US. The recall was initiated on 11 May 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2580-2026
- FDA event ID
- 99063
- Recalling firm
- Boston Scientific, Maple Grove, MN
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 11 May 2026
- FDA classified
- 25 Jun 2026
- Reported
- 1 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Packaging Defects
- Device type
- Infusion Pumps
Timeline
| 11 May 2026 | Recall initiated by company | |
| 25 Jun 2026 | Classified by FDA | +45 days |
| 1 Jul 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
Where it was distributed
US Nationwide distribution in the state of OH.
Questions about this recall
Why was it recalled?
There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
Which lots are affected?
GTIN 00850014110147, Serial Number 20175
Where was it sold?
US Nationwide distribution in the state of OH.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Infusion Pumps recalls
All 549| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | BD Alaris Pump Infusion Sets 10561554* recalled by BD Switzerland Sarl | BD Switzerland Sarl | Other | Nationwide |
| Device | CLASS II | IV Non-Dedicated Gravity Administration Sets with drip chambers recalled | ICU Medical | Foreign Material | Nationwide |
| Device | CLASS II | Plum administration sets recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |