PowerFlow, ChronoFlex A710962Recalls & reported problems

Summary

The FDA's MAUDE database contains 133 adverse event reports that list this exact device (DI 00801741129438), received between Sep 8, 2017 and Sep 28, 2026 — classified as 57 injuries, 76 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (28 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 133 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Device Appears to Trigger Rejection; Obstruction of Flow

  It was reported through the litigation process that, sometime after the port placement, the patient was diagnosed with an unspecified infection, thrombosis and occlusion. However, the current status of the patient was unknown.

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

  MAUDE report 50911647 ↗
• InjuryAug 27, 2026Difficult to Flush; Fracture; Device Appears to Trigger Rejection; Improper or Incorrect Procedure or Method; Suction Problem; Obstruction of Flow; Air/Gas in Device

  On (b)(6) 2026, a patient underwent port placement procedure using the PowerFlow Apheresis Port. On (b)(6) 2026, during a red blood cell exchange procedure, the healthcare worker reported successful access of the implanted port on the first attempt without difficulty. Blood return was obtained, and there was no pain or swelling at the port site upon initial access. After 107 mL of blood had been removed, air was identified in the inlet line. A clot was subsequently observed in the cartridge, and no flow was achieved following clot removal. Swelling was then noted in the patients body near the port during a flushing attempt. Additionally, there was an issue with aspiration and infusion. The port was explanted, and upon removal, a crack was reportedly observed in the port. The current status of the patient is unknown.

  Patient problems: Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 50472624 ↗
• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  On (b)(6) 2024, a 17-year-old female patient underwent a port placement procedure using a Power Flow Apheresis Port. Following the procedure, on (b)(6) 2026, the patient was involved in a car accident. During a subsequent exchange procedure, hemolysis was observed. The healthcare team reportedly ruled out the exchange machine, disposable kit, and blood products as potential causes and suspected that the implanted port may have been damaged during the accident due to seatbelt-related trauma at the implant site. The port was scheduled for replacement and was anticipated to be replaced by (b)(6) 2026. No additional patient complications were reported. The patient's current condition was unknown.

  Patient problems: Hemolysis

  MAUDE report 50400081 ↗
• InjuryAug 12, 2026Device Appears to Trigger Rejection; Obstruction of Flow

  It was reported through the litigation process that, sometime after the port placement procedure, the patient was diagnosed with an unspecified infection, thrombosis and occlusion. However, the current status of the patient remains unknown.

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

  MAUDE report 50220014 ↗
• InjuryAug 12, 2026Device Appears to Trigger Rejection; Obstruction of Flow

  It was reported through the litigation process that, sometime after the port placement procedure, the patient was diagnosed with an unspecified infection, thrombosis and occlusion. However, the current status of the patient remains unknown.

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

  MAUDE report 50219979 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24311818 ↗
• InjuryDec 13, 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 23797174 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 23786843 ↗
• InjuryNov 4, 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 23464101 ↗
• InjuryNov 4, 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 23464100 ↗
• InjuryOct 28, 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 23400754 ↗
• InjuryOct 27, 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 WAS DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23388761 ↗
• InjuryOct 22, 2025Blocked Connection; Migration; Blocked Connection; Migration

  ON (B)(6) 2025, DURING ROUTINE PATIENT FOLLOW-UP, DUE TO IMPLANTED POWERFLOW PORT, THE PATIENT EXPERIENCED COMPLICATIONS RELATED TO CLOTTING, WHICH MAY HAVE IMPACTED THE FUNCTIONALITY OR SAFETY OF THE DEVICE. ADDITIONALLY, THE PORT WAS NOTED TO BE FLOATING WITHIN THE POCKET, MAKING IT DIFFICULT TO ACCESS FOR INTENDED USE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23355676 ↗
• InjuryOct 22, 2025Blocked Connection; Blocked Connection

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, IT WAS DIFFICULT TO ACCESS THE PORT AND WAS FURTHER REPORTED THAT PATIENT DEVELOPED WITH INFECTION AND THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 23355111 ↗
• InjuryOct 22, 2025Blocked Connection; Blocked Connection

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, IT WAS DIFFICULT TO ACCESS THE PORT AND WAS FURTHER REPORTED THAT PATIENT DEVELOPED WITH INFECTION AND THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 23354939 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT W PORT PLACEMENT PROCEDURE USING APHERESIS PORT. POST PORT PLACEMENT, IT WAS REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED BLEEDING FROM THE SITE AFTER THE APHERESIS WAS COMPLETED. IT WAS FURTHER REPORTED THAT PATIENT ALLEGEDLY EXPERIENCED PAIN AND DISCOMFORT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Discomfort; Hematoma; Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 23070831 ↗
• MalfunctionSep 11, 2025Difficult to Flush; Suction Problem; Blocked Connection; Difficult to Flush; Suction Problem; Blocked Connection

  A PATIENT UNDERWENT IMPLANTATION OF TWO POWERFLOW IMPLANTABLE PORTS. SOMETIMES LATER, IT WAS REPORTED THAT ONE OF THE PORTS IS EXPERIENCING ACCESS ISSUES. DESPITE CONFIRMATION FROM INTERVENTIONAL RADIOLOGY (IR) THAT THE PLACEMENT AND POSITIONING APPEARED SATISFACTORY, INFUSION STAFF CONTINUE TO ENCOUNTER DIFFICULTY ACCESSING AS WELL AS INFUSION AND ASPIRATION ISSUES FOR THERAPY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23023770 ↗
• InjuryJul 2, 2025Obstruction of Flow; Blocked Connection; Migration; Obstruction of Flow; Blocked Connection; Migration

  A FEMALE PATIENT UNDERWENT A PORT PLACEMENT SURGERY USING THE APHERESIS PORT AND IT WAS REPORTED THAT APPROXIMATELY 4 MONTHS POST PORT PLACEMENT, THE NURSES ALLEGEDLY EXPERIENCED DIFFICULTY ACCESSING PORT. IT WAS FURTHER REPORTED THAT THE DEVICE WAS ALLEGEDLY FOUND OCCLUDED AND PORT HAD MIGRATED AND CAUSES THE CATHETER TO NARROW. REPORTEDLY, PATIENT HAD ALLEGEDLY EXPERIENCED PAIN AND HER BLOOD PRESSURE DROPS DURING THE APHERESIS PROCESS AND HAD ANTI-THROMBOLYTICS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Low Blood Pressure/ Hypotension; Pain; Thrombosis/Thrombus

  MAUDE report 22381322 ↗
• InjuryJul 2, 2025Obstruction of Flow; Blocked Connection; Migration; Obstruction of Flow; Blocked Connection; Migration

  A FEMALE PATIENT UNDERWENT A PORT PLACEMENT SURGERY USING THE APHERESIS PORT AND IT WAS REPORTED THAT APPROXIMATELY 4 MONTHS POST PORT PLACEMENT, THE NURSES ALLEGEDLY EXPERIENCED DIFFICULTY ACCESSING PORT. IT WAS FURTHER REPORTED THAT THE DEVICE WAS ALLEGEDLY FOUND OCCLUDED AND PORT HAD MIGRATED AND CAUSES THE CATHETER TO NARROW. REPORTEDLY, PATIENT HAD ALLEGEDLY EXPERIENCED PAIN AND HER BLOOD PRESSURE DROPS DURING THE APHERESIS PROCESS AND HAD ANTI-THROMBOLYTICS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Low Blood Pressure/ Hypotension; Pain; Thrombosis/Thrombus

  MAUDE report 22381319 ↗
• MalfunctionJun 24, 2025Fracture; Suction Problem; Fracture; Suction Problem

  ON (B)(6) 2022, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE APHERESIS PORT. ON (B)(6) 2025, THE DEVICE COULD NOT BE ASPIRATED. IT WAS FURTHER REPORTED THAT UPON CHECKING IT WAS NOTED THAT THE CATHETER ALLEGEDLY FRACTURED AT THE INTERNAL JUGULAR VEIN. REPORTEDLY, THE PORT WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22313362 ↗
• InjuryJun 23, 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 A PORT PLACEMENT, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Bacteremia; Bacterial Infection; Unspecified Infection

  MAUDE report 22305338 ↗
• InjuryJun 23, 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 A PORT PLACEMENT, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22305122 ↗
• InjuryMay 21, 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 A PORT PLACEMENT, THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22058138 ↗
• InjuryMay 20, 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 A PORT PLACEMENT, THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22049672 ↗
• InjuryMay 12, 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 THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22000448 ↗