RecallRadar

FDA Device recall Z-1522-2022

INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump

On 2022-08-31 the FDA classified a Class I recall of INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump by Intera Oncology, citing higher than expected flow rate.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1522-2022
ClassificationClass I
Statusterminated
Initiated2022-07-10
Published2022-08-31
Last updated2026-09-13 11:56 UTC
CompanyIntera Oncology
DistributionAL, CA, IL, KY, MN, MO, NC, NJ, NY, OH, OR, PA, TX

Product

INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.

Reason

Higher than expected flow rate.

Identifiers

code_info
UDI-DI: 00850014110147; Catalogue No. AP03000H; Serial No. 16145, 16151, 16154, 16171, 16177, 16179, 16196, 16201, 1620…UDI-DI: 00850014110147; Catalogue No. AP03000H; Serial No. 16145, 16151, 16154, 16171, 16177, 16179, 16196, 16201, 16204, 16211, 16212, 16219, 16220, 16235, 16244, 16247, 16260, 16270, 16273, 16298, 16304, 16309, 16313, 16319, 16338, 16346, 16354, 16376, 16379, 16389, 16393, 16394, 16395,16402, 16403, 16405, 16408, 16409, 16411, 16425, 16426, 16428, 16433, 16434, 16437, 16450, 16459, 16461, 16464, 16485.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1522-2022%22

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