PowerPort ClearVUE 1606062Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 00801741026416), received between Jun 18, 2018 and Sep 23, 2026 — classified as 3 deaths, 23 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Fracture” (24 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Insufficient Device Problem Information

  It was reported through the litigation process that, sometime after port placement, the port allegedly malfunctioned or experienced a mechanical failure. However, no patient injury was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868149 ↗
• MalfunctionSep 23, 2026Device Markings/Labelling Problem

  On (b)(6) 2026, a patient underwent a port placement procedure using the PowerPort ClearVUE isp. Post procedure, it was reported that an X ray was performed to assess for complications and confirmed that the CT marker was inverted; however, the CV port itself was not inverted. A review of 50 cases implanted during August identified one additional case with a similarly inverted marker. It was further noted that the issue was initially identified in a batch manufactured on August 27, and a retrospective review revealed the same issue in a batch manufactured on August 14. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865155 ↗
• MalfunctionSep 23, 2026Device Markings/Labelling Problem

  On (b)(6)2026, a patient underwent a port placement procedure using the PowerPort ClearVUE isp. Post procedure, it was reported that an X ray was performed to assess for complications and confirmed that the CT marker was inverted; however, the CV port itself was not inverted. A review of 50 cases implanted during August identified one additional case with a similarly inverted marker. It was further noted that the issue was initially identified in a batch manufactured on August 27, and a retrospective review revealed the same issue in a batch manufactured on August 14. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865152 ↗
• DeathAug 27, 2026Device Appears to Trigger Rejection

  It was reported through the litigation process that, sometime after the port placement, the patient was diagnosed with an unspecified infection and thrombosis. It was further reported that the patient eventually expired. However, the cause of death was not reported.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 50472946 ↗
• MalfunctionAug 17, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50272766 ↗
• MalfunctionJul 3, 2026Difficult to Flush

  ON (B)(6) 2026, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE IN THE RIGHT INTERNAL JUGULAR VEIN USING THE POWERPORT CLEARVUE ISP. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED DURING FLUSHING. PORT WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25700846 ↗
• MalfunctionMay 6, 2026Fracture; Material Separation; Deformation Due to Compressive Stress; Naturally Worn

  THE PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING POWERPORT M.R.I ISP FOR CHEMOTHERAPY TREATMENT RELATED TO COLORECTAL CANCER. THE CATHETER WAS USED AS A CHEMOTHERAPY ACCESS LINE AND WAS NO LONGER IN USE FOLLOWING COMPLETION OF TREATMENT, WITH INTERMITTENT FLUSHING AND BACKFLUSHING PERFORMED FOR MAINTENANCE. POST THE PROCEDURE ON (B)(6) 2026, DURING A RECENT CATHETER REMOVAL PROCEDURE, THE DEVICE COMPLETELY FRACTURED WHILE TRACTION WAS APPLIED DURING REMOVAL WITH THE PORT DEVICE BEING HELD, AND THE CATHETER WAS SUBSEQUENTLY SURGICALLY REMOVED FROM THE INSERTION SITE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25091039 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE DEVICE WAS ALLEGEDLY PINCHING THE NERVES OF THE PATIENT RESULTING IN NERVE DAMAGE. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.

  Patient problems: Nerve Damage

  MAUDE report 24557133 ↗
• InjuryMar 10, 2026Obstruction of Flow

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION AND OCCLUSION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Obstruction/Occlusion; Unspecified Infection

  MAUDE report 24554732 ↗
• InjuryMar 10, 2026Obstruction of Flow

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION AND OCCLUSION. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.

  Patient problems: Obstruction/Occlusion; Unspecified Infection

  MAUDE report 24554729 ↗
• MalfunctionMar 5, 2026Fluid/Blood Leak; Fracture

  ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE ISP VIA LEFT INTERNAL JUGULAR VEIN AT TWO TRANSVERSE FINGERBREADTHS BELOW THE LEFT CLAVICLE SITE. ON (B)(6) 2026, POST-PROCEDURE THE PATIENT EXPERIENCED PAIN DURING IV PORT USE. UPON EXAMINATION, IT WAS NOTED THAT THE CATHETER WAS FRACTURED. IT WAS FURTHER REPORTED THAT IT HAD LEAKAGE. THE CATHETER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Pain

  MAUDE report 24516752 ↗
• InjuryMar 5, 2026Device Appears to Trigger Rejection; Improper or Incorrect Procedure or Method

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING POWERPORT ISP. POST THE PROCEDURE, IT WAS REPORTED BY THE CALLER THAT HIS TREATING HOSPITAL ADVISED THAT THE PORT COULD REMAIN UNFLUSHED FOR UP TO 90 DAYS AND INDICATED THEY WOULD NOT FLUSH THE DEVICE WITH HEPARIN. HOWEVER, THE CALLER SOUGHT CONFIRMATION OF THIS INFORMATION, INQUIRED ABOUT RECOMMENDED FLUSHING PRACTICES, AND REPORTED A PAST INSTANCE OF FIBRIN BUILDUP REQUIRING A PORT-A-GRAM. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24516575 ↗
• MalfunctionMar 4, 2026Obstruction of Flow

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE IMPLANTED PORT. DURING THE PROCEDURE IT WAS NOTED THAT THERE WAS A BLOCKAGE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505046 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24386793 ↗
• MalfunctionFeb 19, 2026Fracture; Suction Problem

  ON (B)(6) 2026, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE ISP VIA INTERNAL JUGULAR VEIN. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BLOOD COULD NOT BE DRAWN BACK, AND IT WAS FURTHER NOTED THAT THE NEEDLE HAD A CRACK. THE PATIENT EXPERIENCED PAIN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Pain

  MAUDE report 24386352 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24386347 ↗
• DeathFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH BILATERAL PULMONARY EMBOLISM. IT WAS FURTHER REPORTED THAT THE PATIENT EVENTUALLY EXPIRED. HOWEVER, THE CAUSE OF DEATH WAS NOT REPORTED.

  Patient problems: Pulmonary Embolism

  MAUDE report 24386018 ↗
• MalfunctionFeb 2, 2026Disconnection; Fracture; Material Separation; Suction Problem; Deformation Due to Compressive Stress; Naturally Worn

  ON (B)(6) 2026, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE ISP. DURING THE PROCEDURE IT WAS NOTED THAT THERE WAS NO BACKFLOW. UPON INSPECTION, A DISCONNECTION WAS FOUND AT THE STEM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24231800 ↗
• DeathJan 29, 2026Fracture; Obstruction of Flow

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE CATHETER HAD ALLEGEDLY FRACTURED. ADDITIONALLY, THE PATIENT WAS DIAGNOSED WITH THROMBOSIS AND OCCLUSION. IT WAS FURTHER REPORTED THAT THE PATIENT EVENTUALLY EXPIRED. HOWEVER, THE CAUSE OF DEATH WAS NOT REPORTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24209946 ↗
• MalfunctionJan 14, 2026Obstruction of Flow

  ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE ISP. DURING THE PROCEDURE IT WAS NOTED THAT THERE WAS A BLOCKAGE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24064718 ↗
• MalfunctionJan 12, 2026Suction Problem; Obstruction of Flow

  ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE ISP VIA CEPHALIC VEIN. POST THE PROCEDURE, THE BLOOD FLOW ALLEGEDLY FAILED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24033124 ↗
• MalfunctionDec 24, 2025Fracture; Fracture

  ON (B)(6) 2025, A PATIENT PREPPED FOR A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE ISP VIA THE RIGHT INTERNAL JUGULAR VEIN ON THE RIGHT SIDE OF THE SIXTH THORACIC VERTEBRA. PRIOR TO THE PROCEDURE, OPENING THE PACKAGE, A CRACK WAS FOUND ON THE PLASTIC CONNECTOR AT THE TAIL END OF THE VASCULAR SHEATH. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23886156 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE ISP. IT WAS REPORTED THAT DURING THE PROCEDURE, THE PATIENT CONDITION WAS ALLEGEDLY DETERIORATED SUDDENLY. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23739966 ↗
• MalfunctionNov 11, 2025Device Contamination with Chemical or Other Material; Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT PROCEDURE, THE PORT SEAT'S PUNCTURE MEMBRANE WAS ALLEGEDLY DISCOVERED UNEXPLAINED BLACK SPOT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23519985 ↗
• MalfunctionNov 11, 2025Fracture; Manufacturing, Packaging or Shipping Problem; Fracture; Manufacturing, Packaging or Shipping Problem

  ON (B)(6) 2025 A PATIENT UNDERWENT FOR A PORT PLACEMENT PROCEDURE ON TWO TRANSVERSE FINGERBREADTHS BELOW THE CLAVICLE USING POWERPORT CLEARVUE ISP IMPLANTABLE PORT VIA INTERNAL JUGULAR VEIN SITE. PRIOR TO A PORT PLACEMENT PROCEDURE, INSPECTION OF THE FLUSH KIT PROCEDURE, THE CATHETER TIP ALLEGEDLY FOUND TEARED. ALTHOUGH TRIMMING IT FOR USE WAS CONSIDERED, CONCERNS AROSE THAT OTHER SECTIONS MIGHT ALSO BE COMPROMISED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23519984 ↗