Class II recallCompleted

Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, recall — FDA event 99063

FDA · FDA event 99063 · Posted Jun 25, 2026

Published Jun 25, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

There is the potential for leakage along the drug pathway from the pump through the end of the catheter.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

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.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This FDA record lists Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, by Boston Scientific Corporation.

Products affected by FDA event 99063
Model	Description	Lot / serial range	Manufactured	Status
Z-2580-2026	Z-2580-2026	GTIN 00850014110147, Serial Number 20175	Not provided in the normalized record	Completed

Distribution: US Nationwide distribution in the state of OH.
Units affected: See official FDA record
Category: Infusion pumps

Timeline

May 11, 2026
Recall initiated
Date recorded by the FDA.
Jun 25, 2026
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 99063
Published: Jun 25, 2026
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

How MedWatcher checks these sources

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In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

FDA · FDA event 99192Posted Jul 10, 2026

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Plum Duo Infusion Pump, 40002-0401 recall — FDA event 98872

Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.

FDA · FDA event 98872Posted Jun 5, 2026

Class I recallOngoing

LVP software of the Ivenix Infusion System (IIS) recall — FDA event 98929

Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.

FDA · FDA event 98929Posted Jun 3, 2026

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Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, recall — FDA event 99063

FDA · FDA event 99063 · Posted Jun 25, 2026

Published Jun 25, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

Affected products and models

This FDA record lists Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, by Boston Scientific Corporation.

Products affected by FDA event 99063
Model	Description	Lot / serial range	Manufactured	Status
Z-2580-2026	Z-2580-2026	GTIN 00850014110147, Serial Number 20175	Not provided in the normalized record	Completed

Distribution

US Nationwide distribution in the state of OH.

Units affected

See official FDA record

ICU Medical Plum Duo Infusion Pump, v1 recall — FDA event 99192

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

FDA · FDA event 99192Posted Jul 10, 2026

Class II recallOngoing

Plum Duo Infusion Pump, 40002-0401 recall — FDA event 98872

FDA · FDA event 98872Posted Jun 5, 2026

Class I recallOngoing

LVP software of the Ivenix Infusion System (IIS) recall — FDA event 98929

FDA · FDA event 98929Posted Jun 3, 2026

Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, recall — FDA event 99063

Follow Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H,

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, recall — FDA event 99063

Follow Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H,

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline