BardPort 0606100Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00801741026041), received between Jan 17, 2018 and Jun 4, 2026 — classified as 1 death, 27 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Fracture” (18 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, ON OR ABOUT (B)(6) 2015, THE PATIENT UNDERWENT PORT PLACEMENT VIA THE RIGHT SUBCLAVIAN VEIN FOR CHEMOTHERAPY IV ACCESS RELATED TO CANCER OF THE TONGUE. APPROXIMATELY TWO MONTHS AND FOUR DAYS LATER, ON OR ABOUT (B)(6) 2015, THE PATIENT TESTED POSITIVE FOR METHICILLIN SUSCEPTIBLE STAPHYLOCOCCUS AUREUS (MSSA) AND WAS DIAGNOSED WITH SEVERE SEPSIS AND A PORT A CATH INFECTION. THE PORT WAS SUBSEQUENTLY REMOVED ON THE SAME DAY. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Bacterial Infection; Sepsis; Unspecified Infection

  MAUDE report 25390589 ↗
• MalfunctionMar 9, 2026Fracture

  IT WAS REPORTED THROUGH THE LITIGATION THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PORT MALFUNCTIONED AND THE CATHETER ALLEGEDLY FRACTURED. HOWEVER, THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543696 ↗
• InjuryNov 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY FOUR MONTHS AND NINETEEN DAYS OF PORT PLACEMENT PROCEDURE VIA LEFT SUBCLAVIAN VEIN DUE TO THE NEED TO TREAT SICKLE CELL DISEASE, PLAINTIFF PRESENTED TO HOSPITAL WITH COMPLAINTS OF YELLOW DISCHARGE COMING FROM THE DEVICE. BLOOD CULTURES WERE DRAWN AND CAME BACK POSITIVE FOR BACILLUS. REPORTEDLY, THE PORT WAS REMOVED. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacterial Infection

  MAUDE report 23531568 ↗
• MalfunctionJun 5, 2025Fracture; Fracture

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME AFTER PORT PLACEMENT PROCEDURE, THE PORT CATHETER FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22148033 ↗
• MalfunctionOct 10, 2024Malposition of Device; Deformation Due to Compressive Stress; Malposition of Device; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY TAKEN AN ODD DIRECTION AT THE LEVEL OF THE CLAVICLE, AND PROBABLY CAUGHT UP ON SOME CARTILAGE. IT WAS FURTHER REPORTED THAT THE ATTEMPTS AT STRAIGHTENING THE CATHETER WERE UNSUCCESSFUL, BUT THE CATHETER IS FUNCTIONING WELL WITHOUT ANY DIFFICULTY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20418173 ↗
• MalfunctionOct 10, 2024Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT TWO YEARS, TWO MONTHS AND TWENTY-FOUR DAYS POST A PORT PLACEMENT, IN THE PROCESS OF REMOVING THE PORT, IT WAS NOTED THAT THE CONNECTOR THAT HOLDS THE CATHETER ONTO THE PORT BODY HAD FRACTURED LENGTHWISE IN HALF AND WAS NOT INTACT. IT WAS FURTHER REPORTED THAT THE PIECES WERE SEPARATE FROM EACH OTHER BUT HELD WITHIN A FIBROUS CAPSULE. REPORTEDLY, THE PORT WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20418079 ↗
• DeathOct 1, 2024Fracture; Material Separation; Material Twisted/Bent; Migration; Fracture; Material Separation; Material Twisted/Bent; Migration

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

  Patient problems: Embolism/Embolus; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20343470 ↗
• MalfunctionSep 9, 2024Fracture; Fracture

  IT WAS REPORTED THAT SOMETIMES POST A PORT PLACEMENT PROCEDURE, THE CATHETER WAS PARTIALLY FRACTURED. REPORTEDLY, THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20171497 ↗
• InjuryJul 25, 2024Reflux within Device; Suction Problem; Reflux within Device; Suction Problem

  IT WAS REPORTED THAT SOMETIMES POST A PORT PLACEMENT, THERE WAS A BLOOD POOLING AT THE ACCESS SITE AND REGURGITATION OF BLOOD IN THE CATHETER. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS FINE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19824538 ↗
• MalfunctionJul 25, 2024Reflux within Device; Suction Problem; Reflux within Device; Suction Problem

  IT WAS REPORTED THAT SOMETIMES POST A PORT PLACEMENT, THERE WAS A BLOOD POOLING AT THE ACCESS SITE AND REGURGITATION OF BLOOD IN THE CATHETER. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS FINE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19824479 ↗
• MalfunctionJul 13, 2024Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE TIP OF THE DILATOR WAS ALLEGEDLY FOUND TO BE BROKEN OFF WHILE REMOVING FROM THE PATIENT'S SKIN. THE PROCEDURE WAS COMPLETED BY USING A NEW DILATOR. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19736765 ↗
• InjuryMay 29, 2024Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THE CATHETER ALLEGEDLY TOOK AN ODD DIRECTION AT THE LEVEL OF THE CLAVICLE AND ATTEMPTS AT STRAIGHTENING IT WERE UNSUCCESSFUL, BUT THE CATHETER FUNCTIONED WELL WITHOUT ANY DIFFICULTY. IT WAS FURTHER REPORTED THAT TWO YEARS, TWO MONTHS AND TWENTY-SIX DAYS POST THE PORT PLACEMENT, IN THE PROCESS OF REMOVING THE PORT, THE CONNECTOR THAT HOLDS THE CATHETER ONTO THE PORT BODY WAS ALLEGEDLY FOUND TO BE FRACTURED LENGTHWISE IN HALF AND WAS NOT INTACT. FURTHERMORE, THE PIECES WERE SEPARATE FROM EACH OTHER BUT HELD WITHIN A FIBROUS CAPSULE, AND A SMALL BROKEN PIECE HAD MOVED SLIGHTLY. REPORTEDLY, THE CAPSULE WAS GROSSLY DISSECTED, AND THE PIECES WERE REMOVED WITH FORCEPS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 19413539 ↗
• InjuryMay 14, 2024Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND SWELLING WHICH WERE OBSERVED IN THE RIGHT UPPER LIMB WHEN THE CATHETER WAS ACTIVATED IN THE CHEMOTHERAPY DEPARTMENT. IT WAS FURTHER REPORTED THAT CATHETER WAS BROKEN AND IT WAS ALLEGEDLY FOUND IN THE INTRACARDIAC AREA. REPORTEDLY, THE CATHETER WAS REMOVED BY RADIO INTERVENTION AND THERE WAS EVIDENCE OF A BREAK IN THE PORT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Swelling/ Edema

  MAUDE report 19308070 ↗
• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 19247071 ↗
• InjuryNov 16, 2023Disconnection; Migration or Expulsion of Device; Migration; Disconnection; Migration or Expulsion of Device; Migration

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT VIA THE RIGHT INTERNAL JUGULAR VEIN, THE PORT WAS ALLEGEDLY MIGRATED TO THE RIGHT VENTRICLE. REPORTEDLY, THE PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 18154854 ↗
• MalfunctionOct 2, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE DILATOR ALLEGEDLY HAD A DEFORMITY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17850067 ↗
• MalfunctionSep 6, 2023Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT THREE WEEKS AND SIX DAYS POST PORT PLACEMENT VIA THE LEFT SUBCLAVIAN VEIN, THE CONNECTOR THAT ATTACHES TO THE IMPLANTED PORT TO THE CATHETER WAS ALLEGEDLY FRACTURED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS ALLEGEDLY SEPARATED. FURTHERMORE, THE PATIENT EXPERIENCED LOCAL BURNING, PAIN AND EDEMA. HOWEVER, THERE IS NO INFORMATION PROVIDED REGARDING TREATMENT OR MEDICATION FOR THESE SYMPTOMS. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17688687 ↗
• MalfunctionAug 25, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE DISTAL PART OF THE CATHETER WAS ALLEGEDLY TORN DURING THE INSERTION OF THE CONNECTION RING TO THE IMPLANTABLE CHAMBER. THE DISTAL PART WAS CUT AND THE CATHETER WAS RECONNECTED TO THE IMPLANTABLE CHAMBER WITHOUT THE RING JOINING THE END OF THE CHAMBER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15291698 ↗
• InjuryAug 1, 2022Disconnection; Fracture; Material Separation; Connection Problem; Migration; Disconnection; Fracture; Material Separation; Connection Problem; Migration

  IT WAS REPORTED THAT FORTY EIGHT DAYS POST PORT IMPLANTATION PROCEDURE, THE DISLOCATION WAS ALLEGEDLY FOUND BETWEEN THE CATHETER AND THE CHAMBER HOUSING. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED BY USING SURGICAL OPERATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE PATIENT REPORTED TO BE STABLE.

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

  MAUDE report 15137416 ↗
• MalfunctionNov 2, 2021Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE DISTAL END OF THE DEVICE WAS ALLEGEDLY NOTED TO BE DEFORMED DURING INSERTION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12738330 ↗
• InjuryOct 26, 2021Disconnection; Fracture; Material Separation; Detachment of Device or Device Component; Migration; Disconnection; Fracture; Material Separation; Detachment of Device or Device Component; Migration

  IT WAS REPORTED THAT ONE YEAR POST CATHETER PLACEMENT PROCEDURE AND UPON X-RAY EXAMINATION, THE CATHETER OF THE DEVICE WAS ALLEGEDLY FOUND TO BE FRACTURED. IT WAS FURTHER NOTED THAT A PART OF THE CATHETER HAD MIGRATED TO THE PULMONARY ARTERY. THE DEVICE WAS REMOVED BY ADDITIONAL SURGERY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 12695881 ↗
• MalfunctionAug 26, 2021Difficult to Flush; Fracture; Material Puncture/Hole; Difficult to Flush; Fracture; Material Puncture/Hole

  IT WAS REPORTED THAT DURING THE PORT PLACEMENT, THE CATHETER ALLEGEDLY PIERCED AT THE RING INSERTION LEVEL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12370639 ↗
• InjuryAug 18, 2021Disconnection; Material Separation; Migration; Disconnection; Material Separation; Migration

  IT WAS REPORTED THAT POST DEVICE IMPLANT AND UPON X-RAY EXAMINATION OF THE CHEST, IT WAS NOTED THAT THE CATHETER OF THE DEVICE HAD ALLEGEDLY MIGRATED INTO THE CARDIAC DUE TO SEPARATION BETWEEN THE CHAMBER AND THE CATHETER. IT WAS FURTHER REPORTED THAT EDEMA WAS WITNESSED ON THE PATIENT. THE DEVICE WAS REPORTED TO BE REMOVED AND REPLACED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Swelling/ Edema

  MAUDE report 12334917 ↗
• InjuryMar 31, 2021Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT, THE CATHETER ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS TRANSFERRED TO INTERVENTIONAL RADIOLOGY FOR THE REMOVAL OF CATHETER UNDER GENERAL ANESTHESIA. REPORTEDLY, THE IMPLANTABLE CHAMBER WAS REMOVED. THE PATIENT EXPERIENCED PAIN AT THE SITE OF THE IMPLANTABLE CHAMBER; HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 11594355 ↗
• MalfunctionMar 31, 2021Failure to Advance; Deformation Due to Compressive Stress; Difficult or Delayed Separation; Failure to Advance; Deformation Due to Compressive Stress; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE PLASTIC STRIP DOES NOT RESIST AND DOES NOT PASS THROUGH THE VESSEL. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593961 ↗