Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump recall
Boston Scientific Corporation is recalling the Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump (model AP-0300H) due to potential leakage along the drug pathway from the pump through the catheter.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a risk-of-harm product (potential leakage in an implanted drug delivery pump) where no injuries have been reported to date. Class II recalls with risk of harm but no reported adverse events typically score at 3 (High) under the rubric.
Plain-English summary
Boston Scientific Corporation is recalling the Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, model AP-0300H, an implantable drug delivery device. The device may develop leakage along the drug pathway from the pump through the end of the catheter.
Patients who have received this device should contact their healthcare provider immediately to discuss the potential leakage risk and determine appropriate next steps. The recalled device has been distributed nationwide in Ohio.
The recalled product
- Product
- Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- GTIN 00850014110147
- Serial Number 20175
Distribution
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