PowerPort M.R.I., ChronoFlex 1808051Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741027017), received between Aug 2, 2018 and Aug 5, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Blocked Connection” (1 report).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2026Device Appears to Trigger Rejection

  It was reported through the litigation process that, sometime after the port placement, the patient was diagnosed with supraventricular tachycardia, acute chest pain, thrombosis and coronary artery disease. However, the current status of the patient was unknown.

  Patient problems: Chest Pain; Tachycardia; Thrombosis/Thrombus

  MAUDE report 50137965 ↗
• MalfunctionNov 10, 2025Suction Problem; Suction Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THERE WAS NO BLOOD RETURN AND THE PORT MALFUNCTIONED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23507773 ↗
• InjuryNov 7, 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 PROCEDURE, THE PATIENT ALLEGEDLY DEVELOPED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 20631040 ↗
• MalfunctionOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE YEARS POST A PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED TINGLING SENSATION IN HER ARM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20357138 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT TWO YEARS THREE MONTHS AND EIGHT DAYS POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED WITH FUNGAL INFECTION. IT WAS FURTHER REPORTED THAT THE INFECTED PORT WAS REMOVED. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Fungal Infection

  MAUDE report 19030566 ↗
• MalfunctionSep 6, 2023Difficult to Flush; Blocked Connection; Difficult to Flush; Blocked Connection

  IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT, ALLEGEDLY UNABLE TO ACCESS THE PORT WITH THE NEEDLE. IT WAS FURTHER REPORTED THAT THE LAST INFUSION ALLEGEDLY TOOK LONGER THAN USUAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17689546 ↗
• MalfunctionJul 17, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 1808051 IMPLANTABLE PORT ALLEGEDLY EXPERIENCED MIGRATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. AGE, WEIGHT, AND GENDER OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10289330 ↗
• MalfunctionAug 26, 2019Material Twisted/Bent

  PT SCHEDULED FOR INSERTION OF A POWER PORT. DURING THE PROCEDURE, THE INTRODUCER FROM THE POWER PORT SET (REF 1808051, LOT REDP0075, EXP 11/30/2020) BENT INTO A "WIGGLE" FORM RATHER THAN MAINTAINING ITS "STRAIGHT" INTEGRITY WHEN USED BY THE SURGEON. A REPLACEMENT INTRODUCER SET WAS OBTAINED AND UTILIZED. THE PT WAS PLACED INTO TRENDELENBURG TO PREVENT AN AIR EMBOLISM DURING THIS TRANSITION TIME. ULTIMATELY, THE POWER PORT WAS PLACED, CONFIRMED BY X-RAY AND PT WENT TO POST-OP AS SCHEDULED. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8935541 ↗
• MalfunctionAug 2, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PORT HAS ALLEGEDLY ROTATED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7744605 ↗