PowerPort ClearVUE 1616070Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00801741026461), received between Jun 8, 2018 and Sep 25, 2026 — classified as 17 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Fracture” (20 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 66 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported through litigation process that on (b)(6) 2023, the patient underwent PowerPort placement via her left internal jugular vein. Approximately four months and five days later, on (b)(6) 2023, the patient was diagnosed with staph aureus bacteremia. Additionally, on or about (b)(6) 2023, patient tested positive for methicillin sensitive staphylococcus aureus infection. Subsequently, on or about (b)(6) 2023, the port was removed. However, the current status of the patient was unknown.

  Patient problems: Bacteremia

  MAUDE report 50894470 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported through litigation process that on or about (b)(6) 2025, the patient underwent PowerPort placement via her right internal jugular vein, for durable IV access for nutrition due to Crohns disease. Approximately one month and twenty seven days later, on or about(b)(6) 2025, the patient was diagnosed with Klebsiella pneumonia and Enterobacter cloacae. Subsequently, on or about (b)(6) 2025, the port was removed. However, the current status of the patient was unknown.

  Patient problems: Bacterial Infection; Pneumonia

  MAUDE report 50894174 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported through litigation process that on or about (b)(6) 2023, the patient underwent PowerPort placement via the left internal jugular vein. Approximately five months and five days later, on or about (b)(6)2024, the patient was diagnosed with staphylococcus hominis and Acinetobacter ursingii. Subsequently, on or about(b)(6)2024, the port was removed. However, the current status of the patient was unknown.

  Patient problems: Bacteremia; Bacterial Infection

  MAUDE report 50893721 ↗
• MalfunctionSep 24, 2026Reflux within Device; Improper or Incorrect Procedure or Method; Malposition of Device

  On (b)(6) 2026, a patient underwent a port placement procedure using the PowerPort ClearVUE Slim. During the procedure, an arterial puncture occurred. The procedure was discontinued after the arterial puncture was identified while a micropuncture kit and sheath introducer from another manufacturer were being used. The arterial puncture was managed with pressure hemostasis and did not require any additional medical or surgical intervention. It was further reported that a significant backflow of blood was observed when the catheter was inserted into the other manufacturer's sheath, leading to the recognition of the arterial puncture. It was also reported that, prior to the puncture, a pocket had been created for port placement, resulting in a scar at the pocket site. A PICC was placed at a later date. The current status of the patient is healthy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50880556 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported through the litigation process that, sometime after the port placement, the patient was diagnosed with an unspecified infection. However, the current status of the patient was unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50096238 ↗
• InjuryMay 27, 2026Device Appears to Trigger Rejection

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

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25297897 ↗
• InjuryMay 12, 2026Fracture

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, ON (B)(6) 2023, A PATIENT UNDERWENT A PORT PLACEMENT USING THE BARD POWERPORT CLEARVUE SLIM ISP IMPLANTABLE PORT CATHETER DEVICE, VIA RIGHT INTERNAL JUGULAR VEIN TO TREAT SYSTEMIC LUPUS ERYTHEMATOSUS. ABOUT TWO YEARS, SIX MONTHS AND TWENTY-EIGHT DAYS LATER, ON (B)(6) 2026, IMAGING CONFIRMED THAT, THE PORT WAS ALLEGEDLY CRACKED. IT WAS ALSO REPORTED THAT THE PATIENT HAD EXTRAVASATION OF THE MEDICATION INTO THE CHEST TISSUE. SUBSEQUENTLY, ON (B)(6) 2026, THE PORT WAS REMOVED. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Extravasation

  MAUDE report 25147236 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 25146488 ↗
• MalfunctionApr 23, 2026Difficult or Delayed Separation

  ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE SLIM. DURING THE PROCEDURE, THE VALVE EQUIPPED SHEATH FAILED TO TEAR PROPERLY AT THE STRAIGHT CUT WHERE THE AIRGUARD WAS ENGAGED. THE REMAINDER OF THE SHEATH WAS PEELED AWAY, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968222 ↗
• MalfunctionApr 16, 2026Fracture; Difficult to Insert; Deformation Due to Compressive Stress

  ON (B)(6) 2026, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE SLIM. DURING THE PROCEDURE, IT WAS NOTED THAT THE SHEATH DILATOR WAS FRAYED AND COULD NOT BE INSERTED PROPERLY, SO THE CATHETER PLACEMENT COULD NOT BE PERFORMED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24902052 ↗
• MalfunctionMar 31, 2026Fracture

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE CATHETER HAD ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24740151 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, A PATIENT UNDERWENT AN IMPLANTABLE PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE SLIM. AFTER SOME TIME, IT WAS REPORTED POST A PORT PLACEMENT, THE PATIENT DEVELOPED A PORT SITE INFECTION, WHICH LED TO REMOVAL OF THE PORT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24684309 ↗
• InjuryDec 22, 2025Fluid/Blood Leak; Fracture; Deformation Due to Compressive Stress; Naturally Worn; Fluid/Blood Leak; Fracture; Deformation Due to Compressive Stress; Naturally Worn

  ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE SLIM. IT WAS REPORTED THAT DURING INFUSION, LEAKAGE WAS OBSERVED DURING DRUG ADMINISTRATION. UPON INSPECTION OF THE CATHETER, CRACKS WERE CONFIRMED. REPORTEDLY, THE DEVICE WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Extravasation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23861439 ↗
• InjuryDec 19, 2025Fluid/Blood Leak; Fracture; Suction Problem; Fluid/Blood Leak; Fracture; Suction Problem

  ON (B)(6)2025, IT WAS REPORTED THAT DURING DRUG ADMINISTRATION VIA AN IMPLANTED PORT, THE PATIENT ALLEGEDLY EXPERIENCED SUBCUTANEOUS LEAKAGE AT THE INTERNAL JUGULAR VEIN INSERTION SITE. IT WAS FURTHER REPORTED THAT THERE WAS A VERTICAL TEAR ALONG THE DIRECTION OF CATHETER TRAVEL AND THE CATHETER HAD A PROBLEM IN BLOOD RETURN OR ASPIRATION. THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.

  Patient problems: Extravasation

  MAUDE report 23847418 ↗
• MalfunctionDec 15, 2025Fracture; Deformation Due to Compressive Stress; Fracture; Deformation Due to Compressive Stress

  ON 20 NOV 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING POWERPORT. DURING INSERTION OF THE SHEATH INTRODUCER, THE SHEATH COMPONENT BECAME FRAYED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23800287 ↗
• MalfunctionOct 14, 2025Fracture; Fracture

  IT WAS REPORTED THAT A 01-YEAR-OLD FEMALE PATIENT UNDERWENT PLACEMENT OF POWERPORT CLEARVUE SLIM. POST PORT PLACEMENT, THE LINE ALLEGEDLY FOUND CRACKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23276004 ↗
• MalfunctionSep 10, 2025Fluid/Blood Leak; Fracture; Material Puncture/Hole; Material Separation; Fluid/Blood Leak; Fracture; Material Puncture/Hole; Material Separation

  ON (B)(6) 2025, A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE FOR AN UNKNOWN MEDICAL CONDITION. SOMETIMES LATER POST PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY CRACKED. THE PATIENT SUBSEQUENTLY UNDERWENT THE DEVICE REMOVAL PROCEDURE ON (B)(6) 2025. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23014710 ↗
• MalfunctionSep 8, 2025Loss of or Failure to Bond; Peeled/Delaminated; Loss of or Failure to Bond; Peeled/Delaminated

  ON (B)(6) 2025, PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE PRODUCT ARRIVED IN A STATE WHERE THE MEDICON SEAL HAD BEEN PEELED OFF AND THEN REATTACHED. THE HOSPITAL REFUSED TO ACCEPT IT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22990350 ↗
• MalfunctionSep 8, 2025Loss of or Failure to Bond; Peeled/Delaminated; Loss of or Failure to Bond; Peeled/Delaminated

  ON (B)(6) 2025, A PATIENT UNDERWENT FOR A PORT PLACEMENT PROCEDURE USING POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE PRODUCT ARRIVED IN A STATE WHERE THE MEDICON SEAL HAD BEEN PEELED OFF AND THEN REATTACHED. THE HOSPITAL REFUSED TO ACCEPT IT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22990298 ↗
• MalfunctionSep 8, 2025Loss of or Failure to Bond; Peeled/Delaminated; Loss of or Failure to Bond; Peeled/Delaminated

  ON (B)(6)2025, A PATIENT UNDERWENT FOR A PORT PLACEMENT PROCEDURE USING POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE PRODUCT ARRIVED IN A STATE WHERE THE MEDICON SEAL HAD BEEN PEELED OFF AND THEN REATTACHED. THE HOSPITAL REFUSED TO ACCEPT IT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22990265 ↗
• MalfunctionSep 8, 2025Loss of or Failure to Bond; Peeled/Delaminated; Loss of or Failure to Bond; Peeled/Delaminated

  ON 15-AUG-2025, PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE PRODUCT ARRIVED IN A STATE WHERE THE MEDICON SEAL HAD BEEN PEELED OFF AND THEN REATTACHED. THE HOSPITAL REFUSED TO ACCEPT IT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22990133 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  It was reported through the litigation process that, on (b)(6), 2019, a patient underwent port placement via the right internal jugular vein for chemotherapy related to lymphoma. Approximately two months later, on December 11, 2019, the patient was diagnosed with bacteremia, sepsis and septic shock. Subsequently, the port was removed on the same day. However, the current status of the patient was unknown.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 22336708 ↗
• MalfunctionJun 23, 2025Component Missing; Component Misassembled; Component Missing; Component Misassembled

  ON (B)(6) 2025, A PATIENT UNDERWENT FOR A LOW ARTIFACT POWER PORT PLACEMENT PROCEDURE. DURING THE PROCEDURE, THERE WERE TWO STRAIGHT NEEDLES AND NO L-SHAPED NEEDLES WERE NOTED. NORMALLY, THERE ARE TWO TYPES OF NON-CORING NEEDLES, STRAIGHT AND L-SHAPED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22306130 ↗
• InjuryApr 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A SUBCUTANEOUS LEAK OCCURRED AS THE AREA BECAME SWOLLEN DURING THE ADMINISTRATION OF THE DRUG IN A PATIENT WITH AN IMPLANTED CV PORT PLACED IN (B)(6) 2025. BUT AFTER REMOVAL, A HUBER NEEDLE WAS PUNCTURED INTO THE CV PORT TO CHECK FOR PASSAGE, BUT THERE WAS NO LEAKAGE FROM THE CATHETER. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Swelling/ Edema

  MAUDE report 21916859 ↗
• MalfunctionApr 11, 2025Difficult to Remove; Defective Component; Difficult to Remove; Defective Component

  IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT PROCEDURE, THE LOCK ON THE SHEATH OF THE MICRO INTRODUCER IS ALLEGEDLY TOO TIGHT AND THE INNER TUBE CANNOT BE REMOVED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21824712 ↗