PowerPort M.R.I., Groshong 4808560Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00801741027345), received between May 9, 2018 and Apr 16, 2026 — classified as 1 death, 19 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Fracture” (20 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 52 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 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 AND THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 24894964 ↗
• InjuryApr 16, 2026Fracture

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE CATHETER ALLEGEDLY FRACTURED. ADDITIONALLY, THE PATIENT WAS DIAGNOSED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24892991 ↗
• InjuryMar 10, 2026Obstruction of Flow

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

  Patient problems: Obstruction/Occlusion; Unspecified Infection

  MAUDE report 24555564 ↗
• MalfunctionDec 15, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23800374 ↗
• DeathDec 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. IT WAS ALSO REPORTED THAT THE PATIENT EVENTUALLY EXPIRED. HOWEVER, THE CAUSE OF DEATH WAS NOT REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 23725057 ↗
• MalfunctionSep 11, 2025Difficult to Flush; Fracture; Material Separation; Difficult to Flush; Fracture; Material Separation

  ON (B)(6)2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT M.R.I. ISP. DURING THE PROCEDURE THERE WAS RESISTANCE WITH FLUSH. IT WAS FOUND THAT CATHETER WAS ALLEGEDLY FRACTURED AND NO CONTRAST MATERIAL PRESENTED IN CATHETER. ADDITIONALLY PATIENT EXPERIENCED PAIN. PORT REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Pain

  MAUDE report 23023725 ↗
• InjuryAug 28, 2025Fracture; Fracture

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

  Patient problems: Unspecified Infection

  MAUDE report 22910755 ↗
• MalfunctionAug 26, 2025Difficult to Flush; Fracture; Material Separation; Defective Component; Deformation Due to Compressive Stress; Difficult to Flush; Fracture; Material Separation; Defective Component; Deformation Due to Compressive Stress

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT M.R.I. ISP. DURING THE PROCEDURE, THERE WAS RESISTANCE WITH FLUSH. IT WAS FOUND THAT CATHETER WAS ALLEGEDLY FRACTURED AND NO CONTRAST MATERIAL WAS PRESENTED IN IT. ADDITIONALLY, THE PATIENT EXPERIENCED PAIN. THE PORT WAS REMOVED AND REPLACED. THERE WERE NO REPORTED PATIENT INJURIES.

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

  MAUDE report 22892090 ↗
• InjuryAug 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 DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 22699788 ↗
• MalfunctionJul 25, 2025Nonstandard Device; Fitting Problem; Component Misassembled; Nonstandard Device; Fitting Problem; Component Misassembled

  ON (B)(6) 2024, A PATIENT WAS PREPPED FOR PORT PLACEMENT PROCEDURE USING THE MRI POWERPORT ISP. PRIOR TO PORT PLACEMENT, THE CATHETER ALLEGEDLY COULD NOT ATTACH TO THE PORT. FURTHER IT WAS FOUND THAT THERE WAS A FITTING AND COMPONENT MISASSEMBLED ISSUES. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22607499 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6), 2019, A FEMALE PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING GROSHONG POWER PORT. IT WAS REPORTED FIVE YEARS SEVEN MONTHS AND FIFTEEN DAYS LATER POST PORT PLACEMENT, A COMPUTED TOMOGRAPHY SCAN THAT SHOWED A HEMATOMA AND THE 4-5 DAYS LATER SHE NOTICED BRUISING AND SWELLING AROUND THE PORT BODY AND EVIDENCE THAT THERE WAS BLEEDING UNDER THE SKIN. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Bruise/Contusion; Hematoma; Hemorrhage/Blood Loss/Bleeding; Swelling/ Edema

  MAUDE report 22411921 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, A FEMALE PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING UNKNOWN POWER PORT. SOMETIME POST PORT PLACEMENT PROCEDURE IN THE FIRST WEEK OF (B)(6) 2025, THE PATIENT EXPERIENCED PULMONARY EMBOLISM AND ANTICOAGULATION TREATMENT WAS STARTED.

  Patient problems: Pulmonary Embolism

  MAUDE report 22411722 ↗
• InjuryApr 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 POST A PORT PLACEMENT, PATIENT WAS ALLEGEDLY DIAGNOSED WITH UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 21783609 ↗
• MalfunctionFeb 26, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21466734 ↗
• MalfunctionFeb 23, 2025Suction Problem; Obstruction of Flow; Suction Problem; Obstruction of Flow

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THERE WAS ALLEGEDLY A DIFFICULTY FROM OBTAINING BLOOD RETURN DUE TO THE ALLEGED OCCLUSION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442705 ↗
• MalfunctionFeb 21, 2025Suction Problem; Obstruction of Flow; Suction Problem; Obstruction of Flow

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THERE WAS AN DIFFICULTY FROM OBTAINING BLOOD RETURNS TO OCCLUSION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21430078 ↗
• MalfunctionFeb 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT TWENTY ONE DAYS POST A PORT PLACEMENT IN THE LEFT SUBCLAVIAN VEIN, THE PORT ALLEGEDLY BROKE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21429943 ↗
• InjuryJan 4, 2025Fracture; Difficult to Remove; Material Separation; Migration; Fracture; Difficult to Remove; Material Separation; Migration

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT VIA THE RIGHT INTERNAL JUGULAR VEIN, THE PORT CATHETER WAS ALLEGEDLY FRACTURED AND HAD ALLEGEDLY MIGRATED INTO THE PATIENT'S RIGHT ATRIUM AND RIGHT VENTRICLE. IT WAS FURTHER REPORTED THAT IT WAS ALLEGEDLY DIFFICULT TO REMOVE THE FRACTURED CATHETER AND PATIENT HAD ALLEGEDLY DEVELOPED SWELLING OVER THE PORT AREA. REPORTEDLY, THE CATHETER WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 21075294 ↗
• MalfunctionOct 13, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE VIA THE LEFT SUBCLAVIAN VEIN, IT WAS FOUND THAT THERE WAS ALLEGEDLY A HOLE IN THE CATHETER OF THE PORT. IT WAS FURTHER REPORTED THAT THE ACCESS OF THE LEFT SUBCLAVIAN VEIN WAS UNSUCCESSFUL THEN TURNED TO ACCESS OF THE LEFT INTERNAL JUGULAR VEIN WITH ULTRASOUND GUIDANCE. FURTHERMORE, THE PORT SYSTEM WAS IMMEDIATELY REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20436519 ↗
• InjurySep 30, 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 INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacteremia; Bacterial Infection; Fungal Infection; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 20331770 ↗
• MalfunctionSep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIMES POST A PORT PLACEMENT PROCEDURE THE PATIENT ALLEGEDLY EXPERIENCING PAIN WITHOUT ANY VISIBLE REDNESS. IT WAS FURTHER REPORTED THAT THERE WAS NO ADDITIONAL INTERVENTION OR MEDICATION PRESCRIBED TO TREAT THE PAIN. THE PORT WAS NOT REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Pain

  MAUDE report 20244547 ↗
• MalfunctionSep 17, 2024

  DURING INSERTION OF POWER PORT, THE SURGEON NOTED A HOLE IN THE CATHETER OF THE POWER PORT. DEVICE IMMEDIATELY EXPLANTED AND A NEW ONE IMPLANTED. ANESTHESIA STARTED 1321 AND ANESTHESIA STOPPED 1433. INITIALLY THE ACCESS OF THE (L) SUBCLAVIAN VEIN WAS UNSUCCESSFUL THEN TURNING TO ACCESS OF THE LEFT INTERNAL JUGULAR WITH ULTRASOUND GUIDANCE. AFTER SECOND POWER PORT PLACEMENT CONFIRMED W/FLUOROSCOPY W/EXCELLENT FORWARD AND BACKFLUSH. PATIENT TO PACU IN STABLE CONDITION AS THEY TOLERATED PROCEDURE WITHOUT ANY COMPLICATIONS OR CONCERNS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20236272 ↗
• MalfunctionSep 8, 2024Fracture; Material Separation; Deformation Due to Compressive Stress; Naturally Worn; Fracture; Material Separation; Deformation Due to Compressive Stress; Naturally Worn

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THE MID CATHETER WAS ALLEGEDLY FOUND TO BE BROKEN UPON REMOVAL. IT WAS FURTHER REPORTED THAT THE BROKEN CATHETER FRAGMENT WAS RETRIEVED. REPORTEDLY, THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20166070 ↗
• InjuryJun 19, 2024Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THE CATHETER WAS ALLEGEDLY FRACTURED. IT WAS FURTHER REPORTED THAT THE FRACTURED CATHETER WAS ALLEGEDLY LOCATED IN THE SUPERIOR VENA CAVA AND RIGHT HEART. FURTHERMORE, THE FRACTURED CATHETER FRAGMENT WAS SUCCESSFULLY RETRIEVED WITH A SNARE DEVICE. HOWEVER, A SECOND FRACTURE IN THE CATHETER WAS ALLEGEDLY NOTED AT THE LEVEL OF THE CLAVICLE. APPARENTLY, NUMEROUS ATTEMPTS HAVE BEEN MADE TO SNARE THIS RETAINED CATHETER FRAGMENT MEASURING ABOUT NINE MILLIMETERS IN LENGTH, WHICH WAS LOCATED WITHIN THE RIGHT INTERNAL JUGULAR VEIN JUST ADJACENT TO THE CONFLUENCE WITH THE SUBCLAVIAN VEIN, POSTERIOR TO THE RIGHT CLAVICULAR HEAD, AND LOCATED PERIPHERALLY WITHIN THE VESSEL LIKELY ORIENTED ALONG THE VESSEL WALL. REPORTEDLY, THIS CATHETER PIECE WAS SUCCESSFULLY REMOVED VIA THE RIGHT NECK. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 19565369 ↗
• MalfunctionJun 13, 2024Contamination; Defective Component; Component Misassembled; Contamination; Defective Component; Component Misassembled

  IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT PROCEDURE, THERE WAS A SMALL PLASTIC TUBE-LIKE DEVICE ALLEGEDLY INSTALLED AT THE END OF THE PEEL-ABLE INTRODUCER. IT WAS FURTHER REPORTED THAT THE LITTLE TUBE WAS VERY SMALL AND MIGHT HAVE BEEN MISSED AND IF IT COULD HAVE BEEN INSTALLED WITH THE PEEL-ABLE INTRODUCER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19526456 ↗