PowerPort 1708160Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741026676), received between Apr 19, 2019 and Jan 26, 2026 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 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 PULMONARY EMBOLISM. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pulmonary Embolism

  MAUDE report 24176020 ↗
• InjuryOct 15, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION AND THROMBOSIS. IT WAS FURTHER REPORTED THERE WAS OCCLUSION. REPORTEDLY THE PATIENT WAS EXPIRED, AND THE CAUSE OF DEATH WAS NOT PROVIDED.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 23288099 ↗
• InjurySep 2, 2025Migration; Migration

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE CATHETER HAD ALLEGEDLY MIGRATED. IT WAS ALSO REPORTED THAT PATIENT DEVELOPED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22936611 ↗
• InjurySep 2, 2025Migration; Migration

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE CATHETER HAD ALLEGEDLY MIGRATED. IT WAS ALSO REPORTED THAT PATIENT DEVELOPED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22936569 ↗
• InjuryAug 19, 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 22836944 ↗
• InjuryFeb 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT TWO WEEKS AND TWO DAYS POST PORT PLACEMENT VIA THE LEFT INTERNAL JUGULAR VEIN, THE PATIENT ALLEGEDLY EXPERIENCED PAIN OVER THE PORT SITE. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED BACTERIAL INFECTION AND THE CULTURES SHOWED POSITIVE FOR METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS AND FOUND TO HAVE SUSTAINED BACTEREMIA. FURTHERMORE, THE PATIENT WAS DIAGNOSED WITH SEPSIS AND SEPTIC EMBOLI. REPORTEDLY, PATIENT WAS TREATED WITH ANTIBIOTICS AND THE INFECTED PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Bacteremia; Bacterial Infection; Embolism/Embolus; Pain; Sepsis; Unspecified Infection

  MAUDE report 18674864 ↗
• MalfunctionNov 29, 2022Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT SOMETIMES POST PORT PLACEMENT PROCEDURE, THE COMPUTED TOMOGRAPHIC RADIOPAQUE MARK WAS ALLEGEDLY NOT VISUALIZED UNDER IMAGING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15875704 ↗
• MalfunctionApr 19, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT DURING PREPARATION OF A PORT PLACEMENT PROCEDURE, WRONG DEVICE WAS ALLEGEDLY SENT IN THE PACKAGE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14139907 ↗
• MalfunctionApr 8, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT DURING PREPARATION OF A PORT PLACEMENT PROCEDURE, THE WRONG TYPE OF PORT WAS ALLEGEDLY SENT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14050042 ↗
• MalfunctionApr 8, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT DURING PREPARATION OF A PORT PLACEMENT PROCEDURE, THE WRONG TYPE OF PORT WAS ALLEGEDLY SENT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14050040 ↗
• InjuryMay 15, 2020Break; Fracture; Migration or Expulsion of Device; Deformation Due to Compressive Stress; Break; Fracture; Migration or Expulsion of Device; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT SOME TIME POST PORT DEVICE IMPLANT IN THE RIGHT CHEST WALL FOR VENOUS ACCESS, IMAGING IDENTIFIED THAT THE CATHETER ALLEGEDLY FRACTURED (BROKE) NEAR THE NOZZLE FROM THE PORT BODY AND MIGRATED INTO THE RIGHT ATRIUM. IT WAS RETRIEVED WITHOUT INCIDENT. IT WAS REPORTED THAT THE PATIENT UNDERWENT FIBRIN SHEATH STRIPPING PROCEDURES. A NEW PORT WAS PLACED AT THE SAME TIME AS REMOVAL AND FOREIGN BODY RETRIEVAL. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 10062959 ↗
• MalfunctionApr 19, 2019Material Deformation; Material Deformation

  THIS REPORT SUMMARIZES FOUR MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODEL 1708160 PP TI ISP 8CF WITH SUTURE PLUGS - BUMPLESS - INTERMEDIATE KIT EXPERIENCED MATERIAL DEFORMATION. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. OF THE FIVE EVENTS, ALL INVOLVED PATIENTS WITH NO REPORTED INJURIES. THE PATIENTS RANGED FROM 38 TO 77 YEARS OF AGE AND WEIGHT WAS NOT PROVIDED. OF THE REPORTED PATIENTS, ONE WAS MALE, THREE WERE FEMALE. THE 1708160 PP TI ISP 8CF WITH SUTURE PLUGS - BUMPLESS - INTERMEDIATE KITS WERE NOT RETURNED FOR DIRECT EXAMINATION, BUT X-RAY IMAGES WERE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8533350 ↗