PowerPort M.R.I., Groshong 1808561Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00801741027123), received between Jun 20, 2018 and Jun 18, 2026 — classified as 13 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (11 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2026Fracture; Material Separation; Migration

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE CATHETER HAD ALLEGEDLY FRACTURED, AND THE FRAGMENT MIGRATED TO THE RIGHT INTERNAL JUGULAR VEIN AND RIGHT ATRIUM. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 25545306 ↗
• MalfunctionMay 12, 2026Migration

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25146486 ↗
• InjuryJan 28, 2026Fracture

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

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24198353 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST PORT PLACEMENT, THE PATIENT DEVELOPED WITH INFECTION AND THROMBOSIS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 23578540 ↗
• MalfunctionSep 4, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22960713 ↗
• MalfunctionAug 12, 2025Fracture; Fracture

  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 22780476 ↗
• InjuryJul 1, 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 22370912 ↗
• MalfunctionJun 30, 2025Fracture; Migration; Fracture; Migration

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22356653 ↗
• InjuryMay 27, 2025Restricted Flow rate; Blocked Connection; Restricted Flow rate; Blocked Connection

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE CATHETER HAD POOR FLOW AND DIFFICULTY ACCESSING AND REQUIRED TPA FREQUENTLY. FURTHERMORE, THE PATIENT WAS DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22085810 ↗
• InjuryNov 27, 2024Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE CATHETER FRACTURED AND THE PATIENT ALLEGEDLY DEVELOPED THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Embolism/Embolus; Thrombosis/Thrombus

  MAUDE report 20794293 ↗
• InjuryJan 2, 2024Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY TWO YEARS LATER POST PORT PLACEMENT PROCEDURE, THE PORT FRACTURED AND MIGRATED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS DIAGNOSED WITH EMBOLISM, TOXIC SHOCK AND INFECTION AND THE PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Embolism/Embolus; Inflammation; Neck Pain; Shock; Unspecified Infection

  MAUDE report 18424364 ↗
• InjuryJul 25, 2023Difficult to Flush; Fracture; Difficult to Remove; Material Separation; Migration; Difficult to Flush; Fracture; Difficult to Remove; Material Separation; Migration

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST PORT PLACEMENT VIA THE RIGHT INTERNAL JUGULAR VEIN, THE PORT ALLEGEDLY DID NOT FLUSH. IT WAS FURTHER REPORTED THAT THE PORT HAD ALLEGEDLY FRACTURED, AND THE FRACTURED PIECE HAD MIGRATED TO THE PATIENT'S HEART. THE CURRENT STATUS OF THE PATENT IS UNKNOWN.

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

  MAUDE report 17386726 ↗
• InjuryApr 4, 2023Fluid/Blood Leak; Fracture; Material Separation; Migration; Fluid/Blood Leak; Fracture; Material Separation; Migration

  IT WAS REPORTED THAT EIGHTEEN DAYS POST PORT PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED BODY SPASMS, HEART PALPITATIONS AND PAIN ON LEFT SIDE. IT WAS FURTHER REPORTED THAT WHEN THE PORT WAS ATTEMPTED TO FLUSH, THE SALINE WAS NOTED TO BE LEAKING AROUND THE PORT PLACEMENT SITE. IT WAS ALSO REPORTED THAT UPON IMAGING, IT WAS CONFIRMED THAT THE TIP OF THE PORT ALLEGEDLY BROKE AND THE PORT TIP ALLEGEDLY PIERCED RIGHT VENTRICLE. REPORTEDLY, THE PATIENT UNDERWENT EMERGENCY SURGERY WHERE THE PORT AND BROKEN PIECE WAS REMOVED, AND RIGHT VENTRICLE WAS TREATED. THE DETAILS ON THIS SURGERY WERE NOT AVAILABLE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Perforation of Vessels

  MAUDE report 16673027 ↗
• InjuryMar 14, 2022Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE IN THE RIGHT INTERNAL JUGULAR VEIN, THE CATHETER ALLEGEDLY FRACTURED AND THE CATHETER MIGRATED FROM SUPERIOR VENA CAVA RIGHT ATRIUM TO CATHETER TIP IN RIGHT ATRIUM WITH FRACTURED END OF CATHETER TIP TO LEFT BRACHIOCEPHALIC VEIN. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED FROM THE PATIENT USING A GOOSENECK SNARE VIA AN ADDITIONAL ACCESS SITE THROUGH RIGHT COMMON FEMORAL VEIN. THE PATIENT REPORTED TO BE STABLE.

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

  MAUDE report 13758231 ↗
• InjurySep 22, 2021Fluid/Blood Leak; Material Protrusion/Extrusion; Fluid/Blood Leak; Material Protrusion/Extrusion

  IT WAS REPORTED THAT ONE YEAR POST PORT PLACEMENT, ALLEGEDLY THERE WAS A POPPING SOUND DURING FLUSHING THE PORT. THE PATIENT ALLEGEDLY HAD NECK AND ARM SWOLLEN AND SORE. UPON X-RAY EXAMINATION, IT WAS OBSERVED THAT THE DEVICE ALLEGEDLY HAD FLUID LEAK. PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Swelling/ Edema

  MAUDE report 12511423 ↗
• MalfunctionJul 27, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT DURING PORT PLACEMENT PROCEDURE, THE CATHETER COMPONENTS WERE ALLEGEDLY MISASSEMBLED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12230910 ↗
• MalfunctionOct 29, 2020Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT PROCEDURE, THE INTRODUCER NEEDLE SYRINGE IS POPPING OFF. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10754158 ↗
• InjuryAug 15, 2019Break; Break

  IT WAS REPORTED THAT SOME TIME POST PORT DEVICE IMPLANT, THE PORT ALLEGEDLY BROKE AND MIGRATED TO THE RIGHT VENTRICLE. IT WAS FURTHER REPORTED THE PORT BODY WAS REMOVED AND THE CATHETER SEGMENT WAS REMOVED AT ANOTHER FACILITY. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 8899305 ↗
• MalfunctionApr 19, 2019Defective Component; Defective Component

  THIS REPORT SUMMARIZES ONE(1) MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL 1808561 IMPLANTABLE PORT DURING PORT DEVICE IMPLANT, WHEN ADVANCING, THE TIP OF THE DILATOR ALLEGEDLY CURLED UP. IT WAS FURTHER REPORTED THAT A NEW PORT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS EVENT INVOLVED ONE PATIENT WITH NO REPORTED PATIENT INJURY. PATIENT AGE, WEIGHT, AND GENDER NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8532608 ↗
• MalfunctionSep 28, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE GUIDEWIRE BENT/FOLDED WHILE IN THE PATIENT¿S VESSEL. THE GUIDEWIRE WAS REMOVED AND ANOTHER GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7920118 ↗
• InjuryJun 20, 2018Break; Break

  IT WAS REPORTED THAT THE CATHETER FRACTURED AND MIGRATED. THE BROKEN CATHETER FRAGMENT WAS RETRIEVED THROUGH RIGHT VENTRICLE. INITIAL ATTEMPTS MADE FOR THE PROXIMAL PORTION WHICH ALLEGEDLY WAS ENDOTHELIALIZED AND INACCESSIBLE. SUCCESSFUL RETRIEVAL OF FOREIGN BODY FROM THE SUPERIOR VENA CAVA AND RIGHT VENTRICLE. THE PROXIMAL PORTION OF THE CATHETER WAS REMOVED DURING SURGERY THE FOLLOWING DAY AND A NEW CATHETER WAS PLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 7623200 ↗