PowerPort M.R.I., ChronoFlex 1808060Recalls & reported problems

Summary

The FDA's MAUDE database contains 383 adverse event reports that list this exact device (DI 00801741027031), received between May 11, 2018 and Sep 30, 2026 — classified as 15 deaths, 273 injuries, 95 malfunctions.

The most frequently reported specific device problem is “Fracture” (51 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 14, 2019Class IIOpen, Classified

   Complaints received that products packaged with the incorrect introducer sheath size.

   Z-0582-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 383 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 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 50944380 ↗
• InjurySep 29, 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 50929317 ↗
• MalfunctionSep 24, 2026Fracture

  It was reported through the litigation process that, sometime after the port placement, the catheter allegedly fractured. However, there was no patient injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50880549 ↗
• MalfunctionAug 18, 2026Packaging Problem

  On (b)(6) 2026, a patient underwent a port placement procedure using the PowerPort M.R.I. isp. During the preparation, the outer plastic package was allegedly broken and sterility found affected. There was no patient contact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50292400 ↗
• MalfunctionAug 17, 2026Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50270306 ↗
• MalfunctionAug 17, 2026Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50270101 ↗
• InjuryAug 13, 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 50232581 ↗
• MalfunctionAug 12, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50218443 ↗
• InjuryAug 10, 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 50191609 ↗
• DeathAug 10, 2026Device Appears to Trigger Rejection

  It was reported through the litigation process that sometime after the port placement, the patient was diagnosed with an unspecified infection and thrombosis. It was further reported that the patient eventually expired. However, the cause of death was not reported.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 50191242 ↗
• InjuryAug 5, 2026Migration

  It was reported through the litigation process that, sometime after the port placement, the port migrated and required surgical intervention. However, the current status of the patient was unknown.

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

  MAUDE report 50137957 ↗
• 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 thrombosis. However, the current status of the patient remains unknown.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50137942 ↗
• InjuryAug 5, 2026Fracture; Obstruction of Flow

  It was reported through the litigation process that, sometime after the port placement procedure, the catheter had allegedly fractured. It was further reported that, patient was diagnosed with an unspecified infection and blood clots. However, the current status of the patient was unknown.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 50137934 ↗
• 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 sepsis. However, the current status of the patient was unknown.

  Patient problems: Sepsis

  MAUDE report 50096236 ↗
• InjuryJul 27, 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 50021885 ↗
• InjuryJul 10, 2026Expulsion

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PORT ALLEGEDLY ERODED. ADDITIONALLY, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION AND SKIN EROSION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Skin Erosion; Unspecified Infection

  MAUDE report 25775937 ↗
• InjuryJun 30, 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 25662689 ↗
• MalfunctionJun 29, 2026Migration

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25650930 ↗
• InjuryJun 29, 2026Migration

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

  Patient problems: Unspecified Infection

  MAUDE report 25649359 ↗
• InjuryJun 28, 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 25647449 ↗
• InjuryJun 24, 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 REMAINS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25606544 ↗
• InjuryJun 22, 2026Expulsion

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED EROSION OR WOUND COMPLICATIONS AT THE PORT BODY SITE. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Skin Erosion; Unspecified Infection

  MAUDE report 25576003 ↗
• InjuryJun 17, 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 25530722 ↗
• InjuryJun 12, 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 25484873 ↗
• InjuryJun 12, 2026Device Appears to Trigger Rejection; Material Protrusion/Extrusion

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, ON (B)(6) 2015, A PATIENT UNDERWENT PORT PLACEMENT PROCEDURE VIA THE RIGHT INTERNAL JUGULAR VEIN FOR CHEMOTHERAPY RELATED TO ENDOCERVICAL CANCER. APPROXIMATELY EIGHTEEN DAYS LATER, ON (B)(6) 2015, THE PATIENT WAS DIAGNOSED MILD ERYTHEMA AROUND THE PORT. ADDITIONALLY, SOME PROTRUSION WITH A SLIGHT OPEN AREA ON THE RIGHT SIDE OF PORT WAS REPORTED. APPROXIMATELY, ONE DAY LATER, ON (B)(6) 2015, THE PATIENT WAS DIAGNOSED WITH A SKIN INFECTION. APPROXIMATELY, ONE MONTH AND SIX DAYS LATER, ON (B)(6) 2015, THE PATIENT WAS DIAGNOSED WITH CHEST PAIN. IT WAS FURTHER REPORTED THAT THE PATIENT DEVELOPED BLOOD CLOT. SUBSEQUENTLY, ON (B)(6) 2015, THE PORT WAS REMOVED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Chest Pain; Erythema; Skin Infection; Thrombosis/Thrombus

  MAUDE report 25481772 ↗