PowerPort 1716070Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00801741026768), received between May 17, 2018 and Feb 26, 2026 — classified as 7 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (3 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 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 IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24451307 ↗
• InjuryDec 29, 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 DIAGNOSED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23907294 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PATIENT DEVELOPED BLOOD CLOTS AND THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23765581 ↗
• MalfunctionAug 12, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING CHRONOFLEX SINGLE-LUMEN POWERPORT. DURING THE PORT PLACEMENT PROCEDURE, IT WAS REPORTED THAT THE TIP OF THE DILATOR WAS ALLEGEDLY FOUND BENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22781006 ↗
• InjuryAug 7, 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 22736492 ↗
• MalfunctionJul 31, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING CHRONOFLEX SINGLE-LUMEN POWERPORT. DURING THE PORT PLACEMENT PROCEDURE, IT WAS REPORTED THAT THE TIP OF THE DILATOR WAS ALLEGEDLY FOUND BENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22673744 ↗
• MalfunctionJul 31, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING CHRONOFLEX SINGLE-LUMEN POWERPORT. DURING THE PORT PLACEMENT PROCEDURE, IT WAS REPORTED THAT THE TIP OF THE DILATOR WAS ALLEGEDLY FOUND BENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22673743 ↗
• InjuryMay 20, 2025Adverse 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, THE PATIENT ALLEGEDLY DEVELOPED WITH UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22049674 ↗
• MalfunctionFeb 11, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT ONE YEAR, FOUR MONTHS AND TWENTY-THREE DAYS POST A PORT PLACEMENT, THE PORT IS ALLEGEDLY ESTIMATED TO BE CRACKED AT 30-40 PERCENT OF THE TOTAL CIRCUMFERENCE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21352842 ↗
• MalfunctionFeb 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT SOMETIMES POST PORT PLACEMENT, THE PORT IS ALLEGEDLY ESTIMATED TO BE CRACKED AT 30-40 PERCENT OF THE TOTAL CIRCUMFERENCE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21352841 ↗
• MalfunctionJul 22, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO PORT PLACEMENT PROCEDURE, THE DEVICE PACKAGING WAS ALLEGEDLY DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19789854 ↗
• InjuryFeb 20, 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, THE PATIENT ALLEGEDLY DEVELOPED THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pain; Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 18738793 ↗
• MalfunctionJul 2, 2021Device Tipped Over; Blocked Connection; Device Tipped Over; Blocked Connection

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT APPROXIMATELY TWO WEEKS POST PORT DEVICE IMPLANT, THE CATHETER ALLEGEDLY HAD POOR AND DIFFICULT INTRAVASCULAR ACCESS AND THE PORT FLIPPED SIDEWAYS IN THE LEFT CHEST POCKET. IT WAS FURTHER REPORTED THAT A SURGERY WAS REQUIRED TO REMOVE THE PORT. THE PATIENT WAS TREATED USING A NEW PORT IMPLANTED IN THE RIGHT CHEST. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12106309 ↗
• MalfunctionOct 12, 2020Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT APPROXIMATELY FOUR YEARS POST PORT PLACEMENT, THE FLUID AND BLOOD WAS ALLEGEDLY LEAKED FROM PORT SITE. IT WAS FURTHER REPORTED THAT THE PORT WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10665219 ↗
• MalfunctionJan 16, 2020Suction Problem; Failure to Infuse; Suction Problem; Failure to Infuse

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 1716070. IMPLANTABLE PORT ALLEGEDLY EXPERIENCED SUCTION ISSUE, FAILURE TO INFUSE. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. BOTH EVENTS DID INVOLVE PATIENTS WITH NO REPORTED PATIENT INJURY. ONE PATIENT IS FEMALE; HOWEVER, THE OTHER PATIENTS¿ WEIGHT, GENDER AND AGE WERE NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9599196 ↗
• MalfunctionApr 19, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL 1716070 IMPLANTABLE PORT EXPERIENCED A TEAR, RIP, OR HOLE IN DEVICE PACKAGING. THIS EVENT WAS REPORTED FROM A SINGLE SOURCE. THIS EVENT HAD NO REPORTED PATIENT INVOLVEMENT. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8533233 ↗
• MalfunctionNov 7, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PORT HAD BEEN IN PLACE FOR APPROXIMATELY FOUR AND A HALF YEARS AND USED WITH NO PROBLEMS WHEN THE PORT WAS ACCESSED TO ADMINISTER IV CONTRAST FOR A CT IVP AND THE PATIENT FELT PAIN. IT WAS ALSO REPORTED THAT THE NURSES NOTICED SLIGHT SWELLING AT THE PORT SITE DURING INJECTION OF THE CONTRAST. A PORT-A-GRAM WAS PERFORMED AND SHOWED A FRACTURE OF THE CATHETER WITH THE CONTRAST EXTRAVASATION AROUND THE TUBING CLOSEST TO THE PORT. THE PORT WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8046060 ↗
• MalfunctionJul 2, 2018Defective Component; Defective Component

  IT WAS REPORTED THAT AN IMPLANTED PORT WAS NOT FUNCTIONING AND WAS REMOVED AND REPLACED. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7657041 ↗
• InjuryJun 29, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED AN INFECTION, FEVER, AND ARM CLOT. IT WAS FURTHER REPORTED THAT THE PORT WAS REMOVED AND THE PORT IS NO LONGER NEEDED. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Fever; Thrombus; Unspecified Infection

  MAUDE report 7650784 ↗
• MalfunctionJun 25, 2018Suction Problem; Aspiration Issue; Suction Problem; Aspiration Issue

  IT WAS REPORTED THAT PORT WAS PLACED 33 DAYS AGO AND THE NURSE CAN ACCESS THE PORT AND IT FLUSHES, BUT IS UNABLE TO GET BLOOD RETURN. CATHFLO/TPA WAS INFUSED, BUT WAS UNSUCCESSFUL. PORT IS SCHEDULED TO BE REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7636360 ↗
• MalfunctionMay 17, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO INSERTION, THE PHYSICIAN NOTICED A 2-3 CM SILVER STRIP IN THE CATHETER. IT WAS FURTHER REPORTED THAT A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 7523551 ↗