FDA Medical Device Recalls (openFDA)
Intera Oncology, Inc.: INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
- Recall number
- Z-1522-2022
- Recalling firm
- Intera Oncology, Inc.
- Product
- INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
- Status
- Terminated
- Initiated
- 2022-07-10
- Posted
- 2022-08-22
- Terminated
- 2023-09-12
- Reason
- Higher than expected flow rate.
- Root cause
- Process design
- Action
- Customers were notified by a combination of letter, call, and/or email of this recall on July 10, 2022. Customers were informed via notification that Intera 3000 Hepatic Artery Infusion Pumps are being recalled due to complaints reporting higher-than-expected flow rates. Customers are asked to secure affected pumps in inventory to ensure they are not implanted and to contact Intera Oncology at 1-800-660-2660 to arrange return of product. Intera requests physicians continue to monitor the pump flow rate per standard refill procedure, and continue to monitor for liver toxicity to adjust dosing as per standard protocols.
- Quantity
- 50 units
- Distribution
- US distribution to states of: AL, CA, IL, KY, MN, MO, NC, NJ, NY, OH, OR, PA, & TX.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- ["P890055"]
- Product code
- LKK
- Firm FEI
- 3015537318
- Firm city
- Wellesley
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28