PowerPort ClearVUE 1606052Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00801741026409), received between Jan 15, 2019 and Jul 27, 2026 — classified as 15 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Fracture” (19 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 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Difficult to Flush

  Patient problems: Chest Pain; Discomfort

  MAUDE report 50032761 ↗
• MalfunctionApr 6, 2026Fracture; Material Separation

  ON (B)(6) 2026, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE ISP. DURING THE PROCEDURE, IT WAS NOTED THAT THE ATTACHED HUBER NEEDLE BROKE OFF. THE PROCEDURE WAS COMPLETED BY ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24787524 ↗
• MalfunctionDec 19, 2025Disconnection; Fracture; Material Separation; Detachment of Device or Device Component; Disconnection; Fracture; Material Separation; Detachment of Device or Device Component

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE ISP. POST THE PROCEDURE ON (B)(6) 2025, IT WAS NOTED THAT THE CATHETER DISCONNECTED FROM THE PORT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23847555 ↗
• MalfunctionDec 10, 2025Fracture; Material Separation; Fracture; Material Separation

  ON (B)(6) 2025, IT WAS REPORTED THAT DURING THE CV PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE ISP, UPON OPENING THE KIT, THE SYRINGE PLUNGER BOTTOM WAS FOUND BROKEN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23764954 ↗
• MalfunctionDec 8, 2025Disconnection; Detachment of Device or Device Component; Disconnection; Detachment of Device or Device Component

  ON (B)(6) A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F INTO THE RIGHT SUBCLAVIAN VEIN. ON (B)(6) 2025, IT WAS REPORTED THAT THE PORT BODY AND CATHETER CONNECTION WAS ALLEGEDLY FOUND DETACHED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23739455 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23655491 ↗
• MalfunctionOct 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE VIA LEFT SUBCLAVIAN VEIN APPROACH USING THE POWERPORT CLEARVUE ISP. ON (B)(6) 2025, SUBCUTANEOUS LEAKAGE WAS FOUND. THE PORT WAS REMOVED ON(B)(6) 2025 AND WAS REPLACED WITH A NEW PORT VIA RIGHT SUBCLAVIAN APPROACH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23242644 ↗
• MalfunctionSep 25, 2025Component Missing; Device Markings/Labelling Problem; Missing Information; Component Missing; Device Markings/Labelling Problem; Missing Information

  ON (B)(6) 2025, A PATIENT WAS PREPPED FOR A PORT PLACEMENT PROCEDURE USING THE POWER PORT CLEAR VUE ISP. PRIOR TO THE PROCEDURE, THE LABEL WAS ALLEGEDLY FOUND TO BE REMOVED WHEN THE ITEM WAS DELIVERED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23141401 ↗
• MalfunctionSep 11, 2025Entrapment of Device; Fracture; Material Separation; Deformation Due to Compressive Stress; Entrapment of Device; Fracture; Material Separation; Deformation Due to Compressive Stress

  ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE INVOLVING THE INSERTION OF A DILATOR OVER A 0.035-INCH GUIDEWIRE USING THE POWERPORT CLEARVUE ISP. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DILATOR BECAME CAUGHT ON THE SKIN, RESULTING IN A PARTIAL LATERAL TEAR OF THE OUTER SHEATH. ADDITIONALLY, THE TIP OF THE SHEATH BENT OVER DURING USE, THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23023421 ↗
• InjurySep 10, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  ON (B)(6) 2024, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE ISP. 11 MONTHS AND 6 DAYS POST PROCEDURE, THE CATHETER WAS ALLEGEDLY FOUND RAPTURED. REPORTEDLY, THE CATHETER ALLEGEDLY FOUND LEAKING. THE DEVICE WAS REMOVED BY INTERVENTIONAL RADIOLOGY. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 23013188 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22661993 ↗
• MalfunctionJul 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2024, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE LOW ARTIFACT POWER PORT. ON (B)(6) 2025 THE PORT ALLEGEDLY LEAKED IN THE MIDDLE OF THE CATHETER. PORT WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22478043 ↗
• MalfunctionJun 24, 2025Fracture; Material Separation; Stretched; Unraveled Material; Failure to Advance; Deformation Due to Compressive Stress; Fracture; Material Separation; Stretched; Unraveled Material; Failure to Advance; Deformation Due to Compressive Stress

  ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE LOW ARTIFACT POWER PORT. DURING THE PROCEDURE WHEN GUIDE WIRE WAS INSERTED INTO A PUNCTURE NEEDLE, THE TIP ALLEGEDLY BROKE OFF, CREATING A LOOP IN THE NEEDLE'S LUMEN AND PREVENTING IT FROM PASSING THROUGH THE NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322147 ↗
• MalfunctionJun 24, 2025Fluid/Blood Leak; Deformation Due to Compressive Stress; Fluid/Blood Leak; Deformation Due to Compressive Stress

  ON (B)(6) 2025, A PATIENT UNDERWENT FOR A PORT PLACEMENT USING POWERPORT CLEARVUE ISP IMPLANTABLE PORT,CHRONOFLEX SINGLE-LUMEN, 6F. SOMETIMES POST A PORT PROCEDURE THE DEVICE ALLEGEDLY FOUND LEAKAGE. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY FOUND TO BE KINKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22313507 ↗
• InjuryJun 20, 2025Disconnection; Fracture; Material Separation; Migration; Disconnection; Fracture; Material Separation; Migration

  ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE LOW ARTIFACT POWER PORT TO SECURE THE ROUTE FOR BLOOD COLLECTION. ON MAY 15TH, THE CATHETER WAS FOUND TO HAVE COME OFF AND FLOWN INTO THE RIGHT VENTRICLE BY CT. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 22294950 ↗
• InjuryJun 20, 2025Improper or Incorrect Procedure or Method; Suction Problem; Improper or Incorrect Procedure or Method; Suction Problem

  ON (B)(6), 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE LOW ARTIFACT POWER PORT TO SECURE THE ROUTE FOR BLOOD COLLECTION. IT WAS LEFT FOR TWO MONTHS WITHOUT FLUSHING. ON (B)(6), WHEN BLOOD WAS COLLECTED, THE BLOOD DID NOT DRAIN AND THERE WAS SWELLING AROUND THE AREA. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Swelling/ Edema

  MAUDE report 22294830 ↗
• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TEN DAYS POST PORT PLACEMENT, THE PATIENT ALLEGEDLY HAD FEVER AND REDNESS. IT WAS FURTHER REPORTED THAT THE METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) WAS DETECTED AT THE CATHETER TIP. REPORTEDLY, THE PORT WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Bacterial Infection; Fever

  MAUDE report 21706038 ↗
• MalfunctionDec 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE DEVICE WAS ALLEGEDLY BROKEN WHEN IT WAS ABOUT TO SUCK THE SALINE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20861849 ↗
• MalfunctionNov 27, 2024Detachment of Device or Device Component; Packaging Problem; Physical Resistance/Sticking; Detachment of Device or Device Component; Packaging Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE FLUSHING CONNECTOR WAS ATTACHED TO THE CUSHIONING MATERIAL, SO WHEN PICKED UP THE CUSHIONING MATERIAL, THE FLUSHING CONNECTOR ALSO LIFTED UP AND FELL OFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20793906 ↗
• InjuryNov 14, 2024Device Tipped Over; Device Tipped Over

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THE REGULAR CT SCAN REVEALED THAT PORT WAS ALLEGEDLY ROTATED ONCE IN THE SUPERIOR VENA CAVA. IT WAS FURTHER REPORTED THAT THERE WAS A CONSIDERABLE AMOUNT OF BLOOD CLOT ON THE TIP END POINT OF THE CATHETER AND ANTICOAGULATION WAS PERFORMED AND IT WAS REMOVED. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 20681434 ↗
• MalfunctionOct 14, 2024Fracture; Material Separation; Difficult or Delayed Separation; Fracture; Material Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, AFTER INSERTING THE CATHETER INTO THE SHEATH TO ATTEMPT TEAR, THE SHEATH ALLEGEDLY COULD NOT BE TORN SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20439250 ↗
• InjurySep 30, 2024Expulsion; Expulsion

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED WITH INFECTION AND SKIN EROSION AT THE PORT SITE. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Skin Erosion; Unspecified Infection

  MAUDE report 20331006 ↗
• MalfunctionAug 28, 2024Fracture; Fitting Problem; Defective Component; Fracture; Fitting Problem; Defective Component

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE STEM ALLEGEDLY BROKE WHILE ATTEMPTING TO CONNECT IT TO THE CATHETER. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY DID NOT CONNECT TO THE STEM PROPERLY, AND IT ALLEGEDLY BROKE WHEN TOUCHED IT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20092946 ↗
• MalfunctionAug 12, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING PREPARATION FOR A PORT PLACEMENT PROCEDURE, THE PORT WAS ALLEGEDLY NOT ABLE TO PASS WATER AS IT WAS FOUND TO BE CLOGGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19961493 ↗
• MalfunctionAug 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWENTY-FIVE DAYS POST A PORT PLACEMENT, THE FLUID ALLEGEDLY LEAKED SUBCUTANEOUSLY EVEN AFTER BEING PUNCTURED. REPORTEDLY, THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19960261 ↗