INTERA AP-03000HRecalls & reported problems

Summary

The FDA's MAUDE database contains 274 adverse event reports that list this exact device (DI 00850014110147), received between Feb 8, 2022 and Sep 29, 2026 — classified as 110 injuries, 164 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (40 reports).

2 FDA recall records name this device's identifier.

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.

Recalls naming this device

1. May 11, 2026Completed

   There is the potential for leakage along the drug pathway from the pump through the end of the catheter.

   Z-2580-2026 · Root cause: Process control · FDA record ↗

2. Jul 10, 2022Terminated

   Higher than expected flow rate.

   Z-1522-2022 · Root cause: Process design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 274 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Material Integrity Problem; No Flow

  It was reported that there was no flow to the pump, resulting in additional surgery.The patient was implanted with an Intera 3000 Hepatic Artery Infusion Pump. During a pump refill procedure on an unknown date, all 30 mL of medication was returned, indicating no flow. Imaging revealed that the catheter was twisted around a suture within the pump pocket. The surgeon opened the pump pocket and unraveled the catheter. The catheter was flushed using a special bolus needle to confirm that it was not occluded, and the pump was re-sutured into the pocket. The troubleshooting resolved the observed catheter twisting. The patient was scheduled for a Hepatic Arterial Perfusion Scintigraphy (HAPS) scan in a few days and a pump refill the following week.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933395 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50916728 ↗
• MalfunctionSep 9, 2026Excess Flow or Over-Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50694784 ↗
• MalfunctionSep 8, 2026Excess Flow or Over-Infusion

  It was reported that the pump was flowing faster than intended. The patient had the Intera 3000 Hepatic Artery Infusion (HAI) Pump implanted in (b)(6) 2026. The pump was first filled with Floxuridine on July 29, 2026, and the patient had no complications. On (b)(6) 2026, the patient contacted Boston Scientific and reported that the pump was running fast, at an average of 1.7 ml/day instead of 1.2 ml/day. The patient reported that her care team was aware, but was unable to resolve the issue via troubleshooting. Follow-up contact was attempted by telephone and email to obtain additional information; no further information was received at the time of this report.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674820 ↗
• MalfunctionAug 29, 2026Excess Flow or Over-Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50510014 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Erosion; Necrosis; Wound Dehiscence

  MAUDE report 50495178 ↗
• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient developed an infection at the pump pocket site, leading to device explant.On(b)(6) 2026, the patient was implanted with an Intera 3000 Hepatic Artery Infusion Pump in the left abdomen. The patient had their pump refilled every two weeks. On (b)(6) 2026, the patient presented for follow-up due to redness at the pump pocket site, signaling infection. The infection was treated by performing a revision procedure on (b)(6) 2026, during which the original pump was explanted, a new pump was implanted, and the replacement device was positioned on the opposite side of the abdomen.It was the physicians opinion that the device and implantation procedure did not contribute to the reported infection. The physician speculated that the infection may have been associated with either the colorectal team's involvement during the combination surgical procedure or inadequate skin preparation with Chloraprep prior to a refill procedure. No other adverse patient events or clinical consequences were reported.

  Patient problems: Unspecified Infection

  MAUDE report 50304657 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed seroma. The physician contacted Boston Scientific to request information regarding the management of the seroma. The seroma was identified during a postoperative follow-up visit approximately three weeks after the implant procedure. The patient had a history of atrial fibrillation and was receiving Eliquis (apixaban), which was reported as a medical condition and concomitant medication. Additional medications included atenolol, dorzolamide, latanoprost, and Bumex.The fluid collection was located directly over the Intera 3000 HAI Pump and presented as painless swelling without redness. The seroma was diagnosed based on physical examination only; no imaging studies were performed. The estimated fluid volume was approximately 50 mL, and the fluid was reported to be slightly bloody. The pump was not explanted or replaced. At the time of reporting, no recurrence of the seroma had been observed.

  Patient problems: Seroma

  MAUDE report 50256092 ↗
• MalfunctionAug 7, 2026Improper Flow or Infusion

  It was reported that the measured flow rate did not match the labeled arterial flow rate.The physician reported that flow rates were measured in several INTERA pumps following their implant procedures and alleged that the measured flow rates did not match the device's labeled arterial flow rates. The specific infusate was not reported. The devices remain implanted in the patients. Good faith efforts are being attempted for additional information regarding patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50175264 ↗
• MalfunctionAug 6, 2026Improper Flow or Infusion

  It was reported that the measured flow rate did not match the labeled arterial flow rate. The physician reported that flow rates were measured in several INTERA pumps following their implant procedures and alleged that the measured flow rates did not match the device's labeled arterial flow rates. The specific infusate was not reported. The devices remain implanted in the patients. Good faith efforts are being attempted for additional information regarding patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50155753 ↗
• MalfunctionJul 27, 2026Insufficient Flow or Under Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50046195 ↗
• InjuryJul 1, 2026Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem

  INTERA ONCOLOGY WAS NOTIFIED ON (B)(6) 2026, OF A PUMP EXCHANGE PROCEDURE. THE ORIGINALLY IMPLANTED PUMP (SERIAL NO. (B)(6)), IMPLANTED ON (B)(6) 2026, WAS ASSOCIATED WITH PERSISTENT WOUND DEHISCENCE AND HEMATOMA, RESULTING IN EXPOSURE AND CONTAMINATION OF THE DEVICE. THE PHYSICIAN REPORTED THAT THE PUMP WAS FUNCTIONING AS INTENDED WITH NO PERFORMANCE ISSUES. DURING SURGICAL EXPLORATION, CONTAMINATION OF THE IMPLANTED PUMP WAS CONFIRMED. THE CONTAMINATED PUMP (SERIAL NO. (B)(6)) WAS EXPLANTED AND REPLACED WITH A NEW PUMP (SERIAL NO. (B)(6)). ACCORDING TO THE PHYSICIAN, THE PUMP EXCHANGE WAS PERFORMED DUE TO CONTAMINATION ASSOCIATED WITH FAILURE OF THE INCISION SITE TO HEAL. THE PHYSICIAN REPORTED THAT THE EVENT WAS NOT RELATED TO PUMP PERFORMANCE OR MALFUNCTION AND STATED THAT THE DEVICE WAS REMOVED BECAUSE IT HAD BECOME EXPOSED SECONDARY TO WOUND HEALING COMPLICATIONS.

  Patient problems: Hematoma; Wound Dehiscence

  MAUDE report 25679635 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  INTERA ONCOLOGY WAS NOTIFIED THAT AN MEDICAL SCIENCE LIAISON (MSL) RECEIVED AN EMAIL FROM THE PHYSICIAN REQUESTING GUIDANCE REGARDING DOSE REDUCTION PROTOCOLS FOR LIVER FUNCTION TEST (LFT) ELEVATIONS ASSOCIATED WITH FLOXURIDINE (FUDR) THERAPY. THE MSL RECOMMENDED A TELEPHONE DISCUSSION, WHICH OCCURRED ON (B)(6) 2026. DURING THE CALL, THE PHYSICIAN REPORTED THAT THE HEPATIC ARTERY INFUSION PUMP HAD BEEN PLACED DURING LIVER RESECTION; HOWEVER, THE PATIENT HAD RESIDUAL GROSS DISEASE IN THE LIVER AND WAS THEREFORE BEING MANAGED AS AN UNRESECTABLE PLACEMENT. THE PHYSICIAN STATED THAT FOLLOWING CYCLE 3 OF FUDR, THE PATIENT EXPERIENCED ELEVATED LFTS PRIOR TO A PLANNED VACATION. AS A RESULT, FLOXURIDINE TREATMENT WAS HELD AND THE PUMP WAS FILLED WITH HEPARIN/SALINE SOLUTION WITHOUT DEXAMETHASONE. THE PHYSICIAN REPORTED THAT THE LFT ELEVATIONS RESOLVED DURING THE TREATMENT HOLD. DUE TO THE PATIENT'S VACATION SCHEDULE, AN ADDITIONAL CYCLE OF HEPARIN/SALINE WITHOUT DEXAMETHASONE WAS ADMINISTERED. UPON THE PATIENT'S RETURN ON (B)(6) 2026, LFT ELEVATIONS WERE AGAIN OBSERVED. THE PHYSICIAN REPORTED THAT THE PUMP WAS REFILLED WITH HEPARIN/SALINE WITHOUT DEXAMETHASONE AND CONTACTED INTERA ONCOLOGY

  Patient problems: Reaction to Medicinal Component of Device

  MAUDE report 25678539 ↗
• InjuryJul 1, 2026Insufficient Flow or Under Infusion; Adverse Event Without Identified Device or Use Problem

  Intera Oncology was notified that an Intera 3000 Hepatic Artery Infusion Pump was flowing glycerin slower-than-expected during routine follow-up. Documented glycerin refill/calculated flow rates were as follows: 0.22 mL/day on (b)(6) 2025 (18 mL residual, 56 days); 0.21 mL/day on (b)(6) 2025 (18 mL residual, 56 days); 0.16 mL/day on (b)(6) 2026 (21 mL residual, 61 days); 0.18 mL/day on (b)(6) 2026 (20 mL residual, 56 days); and 0.186 mL/day on (b)(6) 2026 (24 mL residual, 35 days). The reported glycerin flow remained steady without interruption. The pump was explanted on (b)(6) 2026, primarily due to progression of disease and not solely due to the observed glycerin flow rate.

  Patient problems: Unspecified Hepatic or Biliary Problem

  MAUDE report 25678483 ↗
• MalfunctionJun 15, 2026Inaccurate Delivery; Improper Flow or Infusion

  INTERA ONCOLOGY WAS NOTIFIED OF A PUMP PREPARATION ISSUE PRIOR TO IMPLANTATION. THE PUMP WAS PLACED IN A STERILE WATER WARMER WHILE AWAITING SURGEON PREPARATION. WHEN THE USER ATTEMPTED TO EMPTY THE PUMP RESERVOIR, NO FLUID WAS RETURNED. PER TROUBLESHOOTING PROTOCOL, A 10 ML SYRINGE CONTAINING LOW-DOSE HEPARINIZED SALINE WAS ATTACHED TO THE REFILL NEEDLE AND APPROXIMATELY 5 ML WAS INJECTED INTO THE RESERVOIR. UPON RELEASE OF PRESSURE, NO FLUID RETURNED TO THE SYRINGE AND ONLY AIR BUBBLES WERE OBSERVED. THIS TROUBLESHOOTING STEP WAS REPEATED A SECOND TIME WITH THE SAME RESULT. AS NO FLUID RETURN COULD BE OBTAINED, THE PUMP WAS SUBSEQUENTLY FILLED WITH HIGH-DOSE HEPARINIZED SALINE ACCORDING TO THE PREPARATION PROCEDURE. CORRECT PLACEMENT OF THE REFILL NEEDLE WAS CONFIRMED AFTER EACH 5 ML INCREMENT DURING FILLING. THE PUMP WAS THEN FLUSHED WITH LOW-DOSE HEPARINIZED SALINE PER THE PREPARATION INSTRUCTIONS. THE STERILE WATER WARMER REACHED APPROXIMATELY 103°F. HISTORICALLY, THIS TEMPERATURE HAD NOT RESULTED IN PREPARATION ISSUES AT THE FACILITY. THE CLINICAL TEAM WAITED FOR BEAD FORMATION; HOWEVER, AN ADEQUATE BEAD DID NOT DEVELOP. THE SURGEON INDEPENDENTLY ASSESSED THE PUMP, CONFIRMED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25512971 ↗
• MalfunctionJun 9, 2026Inaccurate Delivery; Improper Flow or Infusion

  INTERA ONCOLOGY WAS NOTIFIED OF A DEVICE ISSUE DURING PUMP PREPARATION PRIOR TO IMPLANTATION. AN INTERA FIELD REPRESENTATIVE PROVIDED ON-SITE SUPPORT. DURING OPERATING ROOM PREPARATION, THE SCRUB NURSE SUCCESSFULLY EMPTIED, REFILLED, AND FLUSHED THE PUMP AT A FLUID WARMER SETTING OF 120°F. BEAD FORMATION WAS OBSERVED AT THIS TEMPERATURE. WHEN THE FLUID WARMER TEMPERATURE WAS REDUCED TO 95°F, IT WAS NOTED THAT AT APPROXIMATELY 109°F THE PUMP WAS NO LONGER PRODUCING A BEAD. THE INTERA FIELD REPRESENTATIVE CONTACTED THE INTERA MEDICAL SCIENCE LIAISON (MSL) FOR GUIDANCE. PER INSTRUCTION, THE CATHETER PATHWAY WAS RE-FLUSHED USING THE SPECIAL BOLUS NEEDLE AND OBSERVED FOR APPROXIMATELY 10 MINUTES; NO BEAD FORMATION OCCURRED. A SMALL ADDITIONAL PORTION OF THE CATHETER WAS THEN TRIMMED, THE CATHETER PATHWAY WAS RE-FLUSHED, AND THE FLUID WARMER TEMPERATURE WAS INCREASED TO 120°F. AN INSUFFICIENT BEAD FORMED BUT DID NOT DEVELOP INTO A FULL BEAD AFTER APPROXIMATELY 15 MINUTES. THE INTERA MSL AND AN ADDITIONAL INTERA REPRESENTATIVE WERE CONSULTED REGARDING THE EVENT. FOLLOWING DISCUSSION, IT WAS RECOMMENDED THAT A BACKUP PUMP (SERIAL NUMBER (B)(6)) BE OPENED AND PREPARED. THE BACKUP PUMP WAS S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25446146 ↗
• InjuryMay 22, 2026Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion; No Flow

  INTERA ONCOLOGY WAS NOTIFIED THAT A PHYSICIAN IMPLANTED AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP ON (B)(6) 2026, WITH A MANUFACTURER-LABELED FLOW RATE OF 1.2 ML/DAY. POST-OPERATIVE HEPATIC ARTERIAL PERFUSION SCINTIGRAPHY (HAPS) SCAN PERFORMED ON (B)(6) 2026, DEMONSTRATED NO EXTRAHEPATIC PERFUSION. THE PATIENT REMAINED HOSPITALIZED FOLLOWING IMPLANTATION AND EXPERIENCED FEVER POST-OPERATIVELY. AT THE FIRST REFILL ON (B)(6) 2026 (16 DAYS POST-IMPLANT), 0 ML RESIDUAL VOLUME ("DRY PUMP") WAS OBSERVED, SUGGESTING POSSIBLE FAST-FLOW CONDITION. DURATION OF DRY PUMP CONDITION AND POTENTIAL INTERRUPTION OF FORWARD CATHETER FLOW WERE UNKNOWN. THE PUMP WAS REFILLED WITH 30 ML HEPARINIZED SALINE WITHOUT ISSUE. INTERA ONCOLOGY MEDICAL SCIENCE LIAISON (MSL) DISCUSSED PRECAUTIONARY BOLUS FLUSH WITH THE SURGEON DUE TO CONCERN FOR POSSIBLE CATHETER CLOTTING; SURGEON ELECTED SHORT-TERM FOLLOW-UP INSTEAD. AT FOLLOW-UP ON (B)(6) 2026, NEARLY THE FULL 30 ML RESIDUAL VOLUME WAS RETURNED, RAISING CONCERN FOR POSSIBLE SLOW-FLOW CONDITION. THE PUMP WAS AGAIN REFILLED WITH 30 ML HEPARINIZED SALINE WITHOUT ISSUE. MSL AGAIN DISCUSSED BOLUS FLUSH AND PROVIDED STANDARD RESPONSE LETTER REGARDING TROUBLESHOOTI

  Patient problems: Fever; Obstruction/Occlusion

  MAUDE report 25257017 ↗
• InjuryMay 22, 2026Device Contamination with Chemical or Other Material

  THE PATIENT UNDERWENT PUMP INSERTION PROCEDURE. DURING INSERTION, THE PUMP BECAME CONTAMINATED SECONDARY TO BOWEL EXPOSURE AND WAS IMMEDIATELY REMOVED FROM THE STERILE FIELD. FOLLOWING DISCUSSION WITH BOSTON SCIENTIFIC SPECIALISTS PRESENT IN THE OPERATING ROOM DURING PUMP REPLACEMENT, IT WAS DISCLOSED THAT THE PHYSICIAN'S RESIDENT WAS PERFORMING THE PROCEDURE. THE PHYSICIAN REQUESTED A REPLACEMENT PUMP DUE TO CONTAMINATION ENCOUNTERED DURING SURGERY. ALTHOUGH FULL VISUAL CONFIRMATION WAS NOT OBTAINED BY THE BOSTON SCIENTIFIC SPECIALIST, THE CONTAMINATION WAS LIKELY RELATED TO INADVERTENT BOWEL NICKING DURING THE SURGICAL PROCEDURE, RESULTING IN NON-STERILE CONTAMINATION OF THE INITIAL PUMP. THE REQUEST FOR REPLACEMENT WAS NOT RELATED TO ANY CONCERN REGARDING PUMP FUNCTIONALITY OR PRODUCT STERILITY UPON OPENING, BUT RATHER TO INTRAOPERATIVE EVENTS OCCURRING DURING THE SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25255980 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED A POSSIBLE INFECTION TO THE PHYSICIAN APPROXIMATELY FIVE DAYS PRIOR TO ADMISSION. THE PATIENT WAS ADVISED TO PRESENT TO THE LOCAL EMERGENCY ROOM FOR EVALUATION AND LATER TRANSFER TO A HOSPITAL, AS THE PATIENT RESIDES APPROXIMATELY FOUR HOURS FROM THE TREATING FACILITY. THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2026. IMAGING WAS PERFORMED ON (B)(6) 2026, AND UPON FURTHER REVIEW, IT WAS DETERMINED THAT PUMP REMOVAL WAS THE BEST COURSE OF ACTION DUE TO DISEASE PROGRESSION WITH TUMOR SPREAD TO THE LUNG. THE PHYSICIAN ALSO REPORTED THAT THE PUMP WAS ERODING THROUGH THE SKIN, AND WITH PROGRESSION OF THE DISEASE, THIS WAS THE REASON FOR REMOVAL. THE PUMP WAS EXPLANTED ON (B)(6) 2026. INFECTION WAS NOT CONFIRMED. THE EXPLANTED PUMP IS BEING DISPOSED OF PER HOSPITAL PROTOCOL.

  Patient problems: Bacterial Infection; Erosion

  MAUDE report 25232970 ↗
• MalfunctionMay 15, 2026Insufficient Flow or Under Infusion

  INTERA ONCOLOGY WAS NOTIFIED THAT AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP FLOW RATE EXPERIENCED SLOW FLOW. ON (B)(6) 2026, THE FLOW RATE WENT FROM AROUND 1.4ML/DAY TO 0.96ML/DAY. ON (B)(6) 2026, THE CATHETER WAS FLUSHED USING THE SPECIAL BOLUS NEEDLE AND A PUMP STUDY WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25185643 ↗
• MalfunctionMay 14, 2026Use of Device Problem

  INTERA ONCOLOGY WAS NOTIFIED BY A PHYSICIAN THAT THE CATHETER WAS NICKED BY A GRASPER WHILE ADVANCING IT THROUGH THE ABDOMINAL WALL. THE TIP OF THE CATHETER WAS REPLACED BY A TAPERED CATHETER. THE PHYSICIAN RESOLVED THE ISSUE WITHIN 30 MINUTES. DURING COMMUNICATION WITH THE CLINIC, THE PHYSICIAN MENTIONED THAT THEY "DO NOT KNOW THAT THE CATHETER WAS NICKED BY A GRASPER, THERE WAS A SMALL HOLE IN THE TUBING THAT WAS DISCOVERED AFTER THE CATHETER WAS PLACED INTO THE ARTERY WHILE FLUSHING. I DO NOT KNOW HOW IT GOT THERE OR IF IT WAS THERE FROM THE BEGINNING. THAT IS ONE HYPOTHESIS.". THERE WAS NO HARM TO THE PATIENT OTHER THAN AN EXTRA 30 MINUTES OF ANESTHESIA TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25178732 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  INTERA ONCOLOGY WAS NOTIFIED BY A PHYSICIAN THAT THROMBOSIS CLOGGED THE CATHETER. THE DOCTOR USED ROBOTIC SURGERY TO REOPEN AND REINSERT THE CATHETER INSIDE THE ABDOMEN. THE PUMP WAS EXPLANTED AND NEW PUMP WAS IMPLANTED ON THE SAME DAY. THE PATIENT CONTINUES TO RECEIVE HEPATIC ARTERY INFUSION (HAI) THERAPY.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25178718 ↗
• MalfunctionMay 13, 2026Insufficient Flow or Under Infusion

  INTERA ONCOLOGY WAS NOTIFIED THAT AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP FLOW RATE EXPERIENCED A SLOW FLOW. ON (B)(6) 2026, THE FLOW RATE WENT FROM AROUND 1.1ML/DAY TO 0.75ML/DAY. ON (B)(6) 2026, THE CATHETER WAS FLUSHED USING THE SPECIAL BOLUS NEEDLE AND A PUMP STUDY WAS DONE. ACCORDING TO THE CLINIC, THE PUMP STUDY RESULT WAS NORMAL. TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED. THE LATEST REFILL RESULT IS 1.07ML/DAY. THE PATIENT DID NOT EXPERIENCE AN ADVERSE REACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164554 ↗
• MalfunctionMay 7, 2026Insufficient Flow or Under Infusion; No Flow; Migration

  INTERA ONCOLOGY RECEIVED A REPORT OF A PATIENT THAT WAS IDENTIFIED DURING FOLLOW-UP WITH THE CLINICAL TEAM ABOUT THE INTERA 3000 HEPATIC ARTERY INFUSION PUMP HAVING SLOW FLOW RATES WHEN POTENTIALLY GLYCERIN WAS BEING ADMINISTERED. THE REVIEW INDICATED SLOW FLOW ASSOCIATED WITH A CATHETER KINK, PRESENT SINCE AT LEAST OCTOBER 2025. THE PATIENT HAD HISTORY WITH THE PUMP FLIPPING, WHICH REQUIRED MANUAL REPOSITIONING AND LATER SURGICAL REVISION. IT IS UNCLEAR HOW MANY EPISODES OF PUMP FLIPPING MAY HAVE OCCURRED AFTER THE SURGICAL REVISION. AT SUBSEQUENT FOLLOW-UP, NO FLOW WAS OBSERVED, AND IMAGING CONFIRMED A KINKED CATHETER. THE PATIENT IS REPORTED TO HAVE PROGRESSIVE DISEASE, AND PUMP EXPLANT IS SCHEDULED FOR ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25118122 ↗
• MalfunctionMay 7, 2026Insufficient Flow or Under Infusion

  INTERA ONCOLOGY RECEIVED A REPORT OF A PATIENT THAT WAS IDENTIFIED DURING FOLLOW-UP WITH THE CLINICAL TEAM ABOUT THE INTERA 3000 HEPATIC ARTERY INFUSION PUMP HAVING SLOW FLOW RATES UNDER GLYCERIN TREATMENTS. THE CLINIC PROVIDED US WITH THE HISTORY OF EACH OF THE REFILL FLOW RATES SINCE ON (B)(6) 2025: ON (B)(6) 2025: 0.23 ML/DAY, ON (B)(6) 2025: 0.23 ML/DAY, ON (B)(6) 2026: 0.14 ML/DAY, ON (B)(6) 2026: 0.11 ML/DAY. THE PATIENT IS PLANNED FOR SHORT-INTERVAL FOLLOW-UP IN 2 TO 4 WEEKS FOR REASSESSMENT OF FLOW RATE, WITH CONSIDERATION OF A BOLUS PATHWAY FLUSH TO FURTHER ASSESS CATHETER PATENCY. ON (B)(6) 2026, THE PATIENT TOLD THE CLINIC THEY DID NOT WANT ADDITIONAL MEDICAL TESTING/EVALUATION, AND THEY CONFIRMED THEY UNDERSTOOD THE RISKS AND BENEFITS THAT WERE EXPLAINED TO THEM. THE PATIENT IS CURRENTLY WITHOUT EVIDENCE OF DISEASE (NED). GLYCERIN IS BEING USED TO MAINTAIN CATHETER PATENCY SHOULD SALVAGE THERAPY BE REQUIRED IN THE FUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25115901 ↗