PowerPort, ChronoFlex 1708060Recalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 00801741026621), received between Jan 26, 2018 and Aug 20, 2026 — classified as 4 deaths, 59 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (9 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 86 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2026Fluid/Blood Leak; Difficult to Flush; Device Tipped Over; Blocked Connection

  It was reported through the litigation process that, sometime after the port placement, the port allegedly flipped or rotated within the pocket, causing difficulty with cannulation, inability to access the port, port malfunction, and medication leakage from the port. Additionally, the patient was diagnosed with an unspecified infection. However, the current status of the patient remains unknown.

  Patient problems: Extravasation; Unspecified Infection

  MAUDE report 50341150 ↗
• InjuryAug 14, 2026Device Appears to Trigger Rejection

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

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50249309 ↗
• DeathAug 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. It was further reported that the patient eventually expired. However, the cause of death was not reported.

  Patient problems: Unspecified Infection

  MAUDE report 50232578 ↗
• 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 was unknown.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50137952 ↗
• InjuryJul 3, 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 25701598 ↗
• MalfunctionJun 30, 2026Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25662966 ↗
• MalfunctionJun 24, 2026Material Twisted/Bent

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY COILED AND DETERIORATED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25604930 ↗
• InjuryMay 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 AN UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 25274873 ↗
• InjuryMay 25, 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 25271089 ↗
• InjuryApr 20, 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 REMAINS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24924511 ↗
• InjuryApr 6, 2026Device Appears to Trigger Rejection; Adverse 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 THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24787804 ↗
• InjuryMar 19, 2026Obstruction of Flow

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT PROCEDURE, THE OBSTRUCTION OF FLOW OCCURRED, AND THE PATIENT 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 24637254 ↗
• InjuryFeb 25, 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 IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24439971 ↗
• InjuryJan 28, 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 IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24197331 ↗
• DeathJan 12, 2026Obstruction of Flow

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME AFTER THE PORT PLACEMENT, THE DEVICE WAS ALLEGEDLY OCCLUDED. ADDITIONALLY, THE PATIENT WAS DIAGNOSED WITH THROMBOSIS AND OCCLUSION. THE PATIENT EVENTUALLY PASSED AWAY; HOWEVER, THE CAUSE OF DEATH WAS NOT DISCLOSED.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 24033546 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT TI ISP. IT WAS REPORTED THAT POST PROCEDURE THE PATIENT HAD ALLEGEDLY EXPERIENCED ALLERGY. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 23986732 ↗
• InjuryDec 22, 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 AFTER PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23862520 ↗
• InjuryDec 9, 2025Device Tipped Over; Migration; Device Tipped Over; Migration

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT, THE PORT MIGRATED AND FLIPPED INTO RIGHT AXILLARY VEIN. ADDITIONALLY, THE PATIENT WAS DIAGNOSED WITH PULMONARY EMBOLISM AND THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 23755165 ↗
• InjuryDec 9, 2025Device Tipped Over; Migration; Device Tipped Over; Migration

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT, THE PORT MIGRATED AND FLIPPED INTO RIGHT AXILLARY VEIN. ADDITIONALLY, THE PATIENT WAS DIAGNOSED WITH PULMONARY EMBOLISM AND THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 23754558 ↗
• DeathDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIMES AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH UNSPECIFIED INFECTION. IT WAS FURTHER REPORTED THAT THE PATIENT EVENTUALLY EXPIRED. HOWEVER, THE CAUSE OF DEATH WAS NOT REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 23690408 ↗
• InjuryNov 27, 2025Fracture; Fracture

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PORT CATHETER FRACTURED. ADDITIONALLY, THE PATIENT DEVELOPED AN UNSPECIFIED INFECTION AND WAS ALSO DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 23665246 ↗
• InjuryNov 25, 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 AND THROMBOSIS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 23645647 ↗
• InjuryNov 25, 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 23643552 ↗
• DeathNov 21, 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 AND PATIENT EVENTUALLY EXPIRED. HOWEVER, THE CAUSE OF THE DEATH WAS NOT REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 23614757 ↗
• InjuryNov 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 ALLEGEDLY DEVELOPED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23532703 ↗