INTERA AP-07004 (REF AP07004)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850014110130), received between Mar 7, 2025 and Nov 18, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE CIRCULATOR STARTED TO SERVE OR PREP KIT TO STERILE FIELD. WHEN THE CIRCULATOR OPENED THE CORNER OF THE PEEL PACK WITH SYRINGE AND TUBING, A SMALL BLACK LOOKING BUG/FLY WAS OBSERVED IN THE PEEL PACK. THE CIRCULATOR IMMEDIATELY CLOSED THE PEEL PACK, PUT IT BACK IN THE OR PREP BOX AND PULLED A NEW OR PREP KIT FROM ANOTHER PUMP BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23587651 ↗
• MalfunctionJul 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  INTERA ONCOLOGY RECEIVED A COMPLAINT FROM A SCRUB TECHNICIAN THAT THEY WERE EMPTYING THE PUMP DURING THE PUMP PREP PROCEDURE AND THE CONNECTION AT THE NON-CORING NEEDLE AND TUBING LEAKED. THE SCRUB TECHNICIAN HAND TIGHTENED THE NEEDLE AND FINISHED EMPTYING THE PUMP. THE SCRUB TECHNICIAN ATTACHED THE HIGH DOSE HEPARIN/SALINE, AND IT STILL LEAKED. SHE TIGHTENED THE NEEDLE AGAIN USING AN INSTRUMENT AND THE LEAK DIMINISHED TO JUST A SMALL DROP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22650114 ↗
• MalfunctionMar 7, 2025Difficult to Flush; Difficult to Flush

  INTERA ONCOLOGY RECEIVED A REPORT OF AN OR PREP KIT NEEDLE (SBN) THAT WOULDN'T FLUSH THE CATHETER. THE PUMP WAS PREPPED WELL AND WAS BEING SUPPORTED THE CASE REMOTELY BY AN INTERA ONCOLOGY CLINICAL ACCOUNT SPECIALISTS (CAS). THE PHYSICIAN IMPLANTED THE PUMP AND CATHETER, NEEDLE WAS FULLY DEPRESSED AND UNCLAMPED, BUT IT WOULD NOT FLUSH. THE CAS REPRESENTATIVE ASKED THE PHYSICIAN TO REMOVE THE NEEDLE, PRIME, RE-ACCESS, HOWEVER IT STILL WOULD NOT FLUSH. ANOTHER INTERA ONCOLOGY EMPLOYEE WALKED THROUGH THE IMPLANT WITH THE PHYSICIAN AND RELATED THE SAME INFORMATION PROVIDED BY THE CAS REPRESENTATIVE. THE PHYSICIAN WAS TOLD TO USE THE BACKUP OR PREP KIT NEEDLE (SBN), TO PRIME AND REACCESS. THE OUTCOME WAS THAT THE PHYSICIAN WAS ABLE TO FLUSH THE CATHETER WITH THE BACKUP OR PREP KIT NEEDLE. INTERA ONCOLOGY ASKED THE PHYSICIAN TO SALVAGE THE NEEDLE AND RETURNED TO INTERA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21549516 ↗