Recall Z-2580-2026

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: Process control

Action taken

Boston 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.