CLASS I Device recall · Reported 31 Aug 2022 · FDA Enforcement Report
Intera 3000 Hepatic Artery Infusion Pump, Sterile recalled
Intera Oncology is recalling Intera 3000 Hepatic Artery Infusion Pump, Sterile, distributed in 13 states. The recall was initiated on 10 Jul 2022 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1522-2022
- FDA event ID
- 90642
- Recalling firm
- Intera Oncology, Wellesley, MA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 10 Jul 2022
- FDA classified
- 22 Aug 2022
- Reported
- 31 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Infusion Pumps
Timeline
| 10 Jul 2022 | Recall initiated by company | |
| 22 Aug 2022 | Classified by FDA | +43 days |
| 31 Aug 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Higher than expected flow rate.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
Where it was distributed
US distribution to states of: AL, CA, IL, KY, MN, MO, NC, NJ, NY, OH, OR, PA, & TX.
AlabamaCaliforniaIllinoisKentuckyMinnesotaMissouriNorth CarolinaNew JerseyNew YorkOhioOregonPennsylvaniaTexas
Questions about this recall
Is Intera 3000 Hepatic Artery Infusion Pump, Sterile recalled?
Yes. Intera Oncology recalled Intera 3000 Hepatic Artery Infusion Pump, Sterile on 10 Jul 2022. The recall is Class I and its status is Terminated. Recall number Z-1522-2022.
Why was it recalled?
Higher than expected flow rate.
Which lots are affected?
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.
Where was it sold?
US distribution to states of: AL, CA, IL, KY, MN, MO, NC, NJ, NY, OH, OR, PA, & TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Infusion Pumps recalls
All 546| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS I | Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product recalled | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical | ICU Medical | Other | Nationwide |
| Device | CLASS II | Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled | Boston Scientific | Packaging Defects | Nationwide |