PowerPort, ChronoFlex 1708061Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00801741026638), received between Jan 15, 2020 and Sep 23, 2026 — classified as 24 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 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 50865892 ↗
• InjuryJun 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 25635303 ↗
• InjuryMay 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 25296828 ↗
• MalfunctionMar 30, 2026Fracture; Material Separation

  ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A PORT PLACEMENT PROCEDURE USING THE POWERPORT ISP IMPLANTABLE PORT. PRIOR TO PROCEDURE THE STAFF OBSERVED THAT A STRAIGHT NEEDLE BROKE OFF WHILE TESTING THE IMPLANTED PORT. THE ISSUE WAS IDENTIFIED DURING DEVICE TESTING PRIOR TO USE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24710348 ↗
• InjuryMar 23, 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 24659671 ↗
• InjuryFeb 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 IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24320344 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT ISP. AFTER THE PROCEDURE, IT WAS REPORTED THE PORT HAD NOT BEEN FLUSHED OR USED FOR A LONG TIME. ADDITIONALLY, THE PATIENT ALSO EXPERIENCED PAIN AND HAD BRUISING AROUND THE PORT SITE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Bruise/Contusion; Pain

  MAUDE report 24255406 ↗
• InjuryDec 10, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PATIENT DEVELOPED OCCLUSION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Obstruction/Occlusion

  MAUDE report 23765156 ↗
• InjuryDec 8, 2025Obstruction of Flow; Obstruction of Flow

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

  Patient problems: Obstruction/Occlusion

  MAUDE report 23736108 ↗
• InjuryDec 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 AND THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 23714131 ↗
• InjuryNov 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY HAD FIBRIN SHEATH FORMED AROUND THE CATHETER. IT WAS ALSO REPORTED THAT THE PATIENT WAS DIAGNOSED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23663863 ↗
• InjuryNov 26, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT POST PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED WITH THROMBOSIS AND FIBRIN SHEATH FORMED AROUND CATHETER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 23655265 ↗
• InjuryNov 6, 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 23484094 ↗
• InjuryNov 5, 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 23473708 ↗
• InjuryOct 29, 2025Decrease in Suction; Fluid/Blood Leak; Decrease in Suction; Fluid/Blood Leak

  A 58-YEAR-OLD FEMALE PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING POWERPORT ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN. IT WAS REPORTED THAT ON (B)(6) 2025 PATIENT ALLEGEDLY EXPERIENCED BURNING SENSATION WITH ATTEMPT TO PUSH SALINE THROUGH PORT, AND PORT WAS DEMONSTRATED SLUGGISH BLOOD RETURN. REPORTEDLY, THE CATHETER WAS ALLEGEDLY FOUND LEAKING. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Burning Sensation

  MAUDE report 23412804 ↗
• InjuryOct 29, 2025Decrease in Suction; Fluid/Blood Leak; Decrease in Suction; Fluid/Blood Leak

  A 58-YEAR-OLD FEMALE PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING POWERPORT ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN. IT WAS REPORTED THAT ON (B)(6) 2024, PATIENT ALLEGEDLY EXPERIENCED BURNING SENSATION WITH ATTEMPT TO PUSH SALINE THROUGH PORT, AND PORT WAS DEMONSTRATED SLUGGISH BLOOD RETURN. REPORTEDLY, THE CATHETER WAS ALLEGEDLY FOUND LEAKING. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Burning Sensation

  MAUDE report 23412757 ↗
• InjuryAug 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PORT DEVELOPED WITH FIBRIN SHEATH FORMATION. IT WAS FURTHER REPORTED THAT PATIENT WAS DIAGNOSED WITH UNSPECIFIED INFECTION AND THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 22921552 ↗
• InjuryAug 26, 2025Fracture; Fracture

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THERE WAS A BREAK ON CATHETER AND THE PATIENT DEVELOPED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22892280 ↗
• InjuryJul 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 22607502 ↗
• InjuryJul 24, 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 IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22585366 ↗
• InjuryJul 7, 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 UNSPECIFIED INFECTION AND THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 22409694 ↗
• MalfunctionJan 21, 2025Fluid/Blood Leak; Difficult to Flush; Fracture; Fluid/Blood Leak; Difficult to Flush; Fracture

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER POST PORT PLACEMENT PROCEDURE, THE PORT ALLEGEDLY DEVELOPED WITH CATHETER FRACTURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Extravasation; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 21197541 ↗
• InjuryAug 7, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT ONE MONTH AND TWENTY ONE DAYS POST A PORT PLACEMENT VIA THE RIGHT INTERNAL JUGULAR VEIN APPROACH, THE CATHETER ALLEGEDLY OCCLUDED. IT WAS FURTHER REPORTED THAT, THE PATIENT REPORTEDLY EXPERIENCED RIGHT NECK PAIN AND WAS ALLEGEDLY DIAGNOSED WITH OCCLUSIVE THROMBOSIS. REPORTEDLY, PATIENT WAS TREATED WITH ANTICOAGULANTS AND PAIN MEDICATIONS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Neck Pain; Thrombosis/Thrombus

  MAUDE report 19926876 ↗
• InjuryJun 14, 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 YEARS, ELEVEN MONTHS AND TWENTY-FOUR DAYS POST A PORT PLACEMENT VIA THE RIGHT INTERNAL JUGULAR VEIN, THE PATIENT ALLEGEDLY EXPERIENCED SWELLING IN FACE AND NECK. IT WAS FURTHER REPORTED THAT PATIENT WAS ALLEGEDLY DIAGNOSED WITH THROMBOSIS OF SUPERIOR VENA CAVA ASSOCIATED WITH THE PORT. REPORTEDLY, THE PORT WAS REMOVED. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 19536459 ↗
• InjuryMay 3, 2024Fracture; Suction Problem; Obstruction of Flow; Device Tipped Over; Deformation Due to Compressive Stress; Fracture; Suction Problem; Obstruction of Flow; Device Tipped Over; Deformation Due to Compressive Stress

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE CATHETER WAS ALLEGEDLY FRACTURED AND THE PATIENT ALLEGEDLY DEVELOPED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 19236886 ↗