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U.S. Department of Health and Human Services

Class 2 Device Recall Intera Oncology

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 Class 2 Device Recall Intera Oncologysee related information
Date Initiated by FirmMay 11, 2026
Date PostedJune 25, 2026
Recall Status1 Completed
Recall NumberZ-2580-2026
Recall Event ID 99063
PMA NumberP890055 
Product Classification Pump, infusion, implanted, programmable - Product Code LKK
ProductIntera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
Code Information GTIN 00850014110147, Serial Number 20175
FEI Number 3002095335
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information ContactClara Johnson
763-494-1133
Manufacturer Reason
for Recall		There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
FDA Determined
Cause 2		Process control
ActionBoston 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 HAI-quality@bsci.com 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.
Quantity in Commerce1 device
DistributionUS Nationwide distribution in the state of OH.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA DatabasePMAs with Product Code = LKK
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