INTERA IP-37957Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850014110093), received between Aug 11, 2023 and Oct 24, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Obstruction of Flow” (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.

• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTERA ONCOLOGY RECEIVED A REPORT FROM A PHYSICIAN THAT THE IMPLANT WAS ABORTED DUE TO PATIENT'S ANATOMY BEING INSUFFICIENT FOR TAPERED CATHETER. THE PHYSICIAN REPORTED THAT THE PUMP WAS FUNCTIONING PROPERLY PRIOR TO IMPLANTATION. DURING COMMUNICATION WITH THE PHYSICIAN, HE MENTIONED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE REACTIONS. HE CONFIRMED THE PUMP WAS IN THE PUMP POCKET AND REMOVED AFTER DETERMINING THAT THE PATIENT'S ANATOMY IS INSUFFICIENT TO THE TAPERED CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23381444 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITERATURE CITATION: DUTTA, A.K., SHANKAR, V., SANTOS, E.G. ET AL. PERCUTANEOUS TRANSHEPATIC ARTERIAL ACCESS FOR COIL EMBOLIZATION OF HEPATIC ARTERY INFUSION PUMP-ASSOCIATED BLEEDING. CVIR ENDOVASC 8, 5 (2025). HTTPS://DOI.ORG/10.1186/S42155-024-00515-W. CASE PRESENTATION A PATIENT PRESENTED WITH AN ENLARGING HEMATOMA DUE TO BLEEDING AT THE GASTRODUODENAL ARTERY HAIP (HEPATIC ARTERY INFUSION PUMP) CATHETER INSERTION SITE. EMERGENT ANGIOGRAPHY REVEALED CONCOMITANT COMMON HEPATIC ARTERY OCCLUSION AND RETROGRADE PERFUSION OF THE GDA VIA TORTUOUS, DIMINUTIVE HEPATIC COLLATERALS WHICH PRECLUDED STANDARD ANTEGRADE APPROACH. COLLATERAL INFOW FROM THE DORSAL PANCREATIC ARTERY WAS UTILIZED TO OPACIFY THE RIGHT HEPATIC ARTERY. THE SEGMENT 5 HEPATIC ARTERY WAS PERCUTANEOUSLY ACCESSED UNDER FLUOROSCOPIC GUIDANCE, AND MICROCOILS WERE DEPLOYED BOTH PROXIMAL AND DISTAL TO ORIGIN OF THE GASTRODUODENAL ARTERY. THE PATIENT REMAINED STABLE THROUGHOUT THE POSTOPERATIVE PERIOD AND WAS DISCHARGED AFTER AN OTHERWISE UNEVENTFUL ADMISSION. FOLLOW-UP COMPUTED TOMOGRAPHY DEMONSTRATED RESOLUTION OF THE HEMATOMA AND NO BLEEDING OR BILIARY COMPLICATION FROM TRANSHEPATIC ACCESS.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21316042 ↗
• InjuryAug 11, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT WITH A INTERA TAPERED CATHETER SPLICED TO A NON-INTERA INFUSION PUMP WAS OCCLUDED. THE PATIENT WAS TO UNDERGO REVISION SURGERY TO REPLACE THE NON-INTERA PUMP WITH AN INTERA PUMP. IT WAS DETERMINED BY THE SURGEON THAT THE CATHETER CLOSEST TO THE GDA (GASTRODUODENAL ARTERY) WAS OCCLUDED. THE OCCLUSION MAY OR MAY NOT HAVE BEEN RELATED TO THE OPERATION OF THE NON-INTERA PUMP. THE PLANNED REVISION WITH THE INTERA PUMP WAS ABORTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17515927 ↗