PowerPort M.R.I., Groshong 9808560Recalls & reported problems

Summary

The FDA's MAUDE database contains 834 adverse event reports that list this exact device (DI 00801741027512), received between Oct 7, 2017 and Sep 24, 2026 — classified as 3 deaths, 221 injuries, 610 malfunctions.

The most frequently reported specific device problem is “Fracture” (577 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 834 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Fluid/Blood Leak; Difficult to Flush; Suction Problem

  A patient underwent a port placement procedure using the PowerPort M.R.I. ISP Port. Sometime after implantation, a nurse observed fluid leaking from the Huber needle puncture site while flushing the port. Aspiration and flushing difficulties were also reported. Further, the port was removed due to suspected CV port occlusion/clogging. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882616 ↗
• MalfunctionSep 24, 2026Suction Problem; Air/Gas in Device

  On (b)(6) 2026, a patient underwent a port placement procedure using the PowerPort M.R.I. isp. During the procedure, after confirming blood backflow, the healthcare professional attempted to withdraw the syringe but was unable to do so. A second attempt was made using saline; however, only air could be drawn up, and the saline could not be aspirated. The procedure was completed using another device. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877871 ↗
• MalfunctionAug 14, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50251847 ↗
• InjuryAug 5, 2026Difficult to Flush; Device Appears to Trigger Rejection; Improper or Incorrect Procedure or Method; Obstruction of Flow

  On (b)(6) 2026, a patient underwent a port placement procedure using a PowerPort M.R.I. isp. On (b)(6) 2026, during an outpatient visit, the port was accessed; however, medication could not be infused through the device. The port was subsequently removed, and a blood like substance was observed adherent near the valve slit at the catheter tip. Following transection of the catheter tip, patency was restored and normal flow was confirmed by flushing the port with normal saline. The obstruction was determined to be due to a clog at the catheter tip. It was reported that blood resembling a clot was adhering to the slit in the catheter valve at the time of removal. The device was retrieved for evaluation. The current status of the patient is unknown.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50144335 ↗
• MalfunctionJul 3, 2026Fracture; Suction Problem; Deformation Due to Compressive Stress

  ON (B)(6) 2026, THE PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT M.R.I. ISP. AFTER SOME TIME, IT WAS REPORTED THAT BLOOD BACKFLOW COULD NOT BE CONFIRMED. AN X-RAY REVEALED KINKING, AND CATHETER DAMAGE WAS IDENTIFIED DURING SURGICAL EXAMINATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25700994 ↗
• MalfunctionMay 20, 2026Stretched; Physical Resistance/Sticking

  ON (B)(6) 2026, A PATIENT UNDERWENT AN IMPLANTABLE PORT PLACEMENT PROCEDURE USING POWERPORT M.R.I. ISP. IT WAS REPORTED THAT DURING A PROCEDURE, THE GUIDEWIRE BECAME STUCK IN THE PUNCTURE NEEDLE AND HAD TO BE REMOVED. THE PROCEDURE WAS COMPLETED USING A RADIFOCUS GW AND A SURFLOW TYPE PUNCTURE NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25226666 ↗
• MalfunctionMay 12, 2026Fracture; Suction Problem; Deformation Due to Compressive Stress; Naturally Worn

  ON (B)(6) 2024 A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT M.R.I. ISP. AFTER SOME TIME, ON (B)(6) 2026, THE POWERPORT WAS REMOVED DUE TO A LACK OF BLOOD BACKFLOW DURING USE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25147008 ↗
• InjuryMay 11, 2026Fluid/Blood Leak; Fracture

  THE PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE IN THE RIGHT INTERNAL JUGULAR VEIN USING THE POWERPORT M.R.I. ISP. POST THE PROCEDURE ON (B)(6) 2026, DURING DRUG ADMINISTRATION, THE PATIENT EXPERIENCED PAIN, AND THE CHEMOTHERAPY MEDICATION LEAKED INTO THE SUBCUTANEOUS TISSUE. FURTHERMORE, THE CATHETER WAS FRACTURED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Extravasation; Pain

  MAUDE report 25134191 ↗
• MalfunctionMay 7, 2026Fracture

  ON (B)(6) 2021, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT M.R.I. ISP. POST THE IMPLANTATION, AN X RAY REVEALED THE COMPLETE FRACTURE OF THE CATHETER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25108771 ↗
• MalfunctionMay 5, 2026Fluid/Blood Leak; Fracture; Material Puncture/Hole; Deformation Due to Compressive Stress; Material Integrity Problem

  ON (B)(6) 2026, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE X PORT ISP M.R.I. DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS A HOLE IN THE CATHETER. IT WAS FURTHER REPORTED THAT THERE WAS LEAKAGE IN THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25077259 ↗
• MalfunctionApr 28, 2026Fracture; Deformation Due to Compressive Stress; Naturally Worn

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT M.R.I. ISP. POST THE PROCEDURE ON (B)(6) 2026, THE CATHETER WAS ALLEGEDLY FOUND FRACTURED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25014538 ↗
• MalfunctionApr 28, 2026Fracture; Material Separation

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT M.R.I. ISP. ON (B)(6) 2026, POST THE PROCEDURE, THE CATHETER WAS ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25011907 ↗
• MalfunctionApr 28, 2026Entrapment of Device; Fracture; Difficult to Remove; Material Separation; Stretched; Unraveled Material; Failure to Advance; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  ON (B)(6) 2026, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT M.R.I. ISP. DURING THE PROCEDURE, IT WAS REPORTED THAT THE GUIDEWIRE AND PUNCTURE NEEDLE BECAME STUCK. THE HEALTHCARE PROFESSIONAL INITIALLY ATTEMPTED PLACEMENT VIA A CUTDOWN APPROACH; HOWEVER, DUE TO VASCULAR CALCIFICATION THAT MADE INSERTION DIFFICULT, THE APPROACH WAS CHANGED TO THE SUBCLAVIAN VEIN. SUBSEQUENTLY, DURING GUIDEWIRE INSERTION, THE GUIDEWIRE LIKELY STRUCK THE VESSEL WALL, PREVENTING PROPER ADVANCEMENT. REPORTEDLY, THE GUIDEWIRE APPEARED TO BECOME STUCK WHEN THE HEALTHCARE PROFESSIONAL ATTEMPTED TO WITHDRAW IT. THE GUIDEWIRE WAS WITHDRAWN TOGETHER WITH THE METAL NEEDLE. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE STRETCHED AND BENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25010849 ↗
• MalfunctionApr 10, 2026Fluid/Blood Leak; Fracture; Material Separation

  ON (B)(6) 2026, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT M.R.I. ISP. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CATHETER WAS ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24844473 ↗
• InjuryMar 30, 2026Fluid/Blood Leak; Fracture; Deformation Due to Compressive Stress; Naturally Worn

  ON (B)(6) 2026, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT M.R.I. ISP. DURING THE PROCEDURE, SUBCUTANEOUS LEAKAGE WAS OBSERVED DURING SALINE INFUSION. UPON REMOVAL, CRACKS WERE NOTED ON THE CATHETER NEAR THE PORT, APPROXIMATELY 8 CM FROM THE PORT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Extravasation

  MAUDE report 24710895 ↗
• MalfunctionMar 24, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE VIA THE INTERNAL JUGULAR VEIN USING A POWERPORT M.R.I. ISP. ON (B)(6) 2025, THE PATIENT REPORTED DISCOMFORT. ON (B)(6) 2026, A CATHETER RUPTURE WAS CONFIRMED, AND THE CATHETER WAS REMOVED ON THE SAME DAY. IT WAS FURTHER REPORTED THAT A RUPTURE OCCURRED WITHIN THE SUBCUTANEOUS TUNNEL IN THE NECK, AND REMOVAL PROCEDURES WERE CARRIED OUT. DURING REMOVAL, WHILE PULLING THE CATHETER FROM THE PORT BODY, THE CATHETER BROKE OFF MIDWAY. NO RESIDUAL MATERIAL REMAINED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24679629 ↗
• MalfunctionMar 24, 2026Fracture; Material Separation; Deformation Due to Compressive Stress; Naturally Worn

  ON (B)(6) 2023, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE VIA THE INTERNAL JUGULAR VEIN USING A POWERPORT M.R.I. ISP. ON (B)(6) 2025, THE PATIENT REPORTED DISCOMFORT. ON (B)(6) 2026, A CATHETER RUPTURE WAS CONFIRMED, AND THE CATHETER WAS REMOVED ON THE SAME DAY. IT WAS FURTHER REPORTED THAT A RUPTURE OCCURRED WITHIN THE SUBCUTANEOUS TUNNEL IN THE NECK, AND REMOVAL PROCEDURES WERE CARRIED OUT. DURING REMOVAL, WHILE PULLING THE CATHETER FROM THE PORT BODY, THE CATHETER BROKE OFF MIDWAY. NO RESIDUAL MATERIAL REMAINED. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 24679272 ↗
• MalfunctionMar 23, 2026Fracture; Loose or Intermittent Connection; Material Separation

  A PATIENT PREPPED FOR A PORT PLACEMENT PROCEDURE USING THE POWER PORT M.R.I. ISP. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE CONNECTOR AND PORT WERE LOOSE AND COULD NOT BE ATTACHED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24659777 ↗
• MalfunctionMar 19, 2026Difficult to Flush; Suction Problem; Obstruction of Flow

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT M.R.I. ISP. POST- PROCEDURE, IT WAS REPORTED THAT THE CATHETER COULD NOT OBTAIN FLOW. IT WAS FURTHER REPORTED THAT THE CATHETER COULD NOT BE FLUSHED AND COULD NOT BE ASPIRATED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24636181 ↗
• MalfunctionMar 13, 2026Fracture; Deformation Due to Compressive Stress; Naturally Worn

  ON (B)(6) 2017, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT M.R.I. ISP. 8 YEARS 10 MONTHS AND 13 DAYS POST PROCEDURE, A KINK OCCURRED IN THE CATHETER DURING USE. THE CATHETER WAS REMOVED AND EXCHANGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24596989 ↗
• InjuryMar 13, 2026Difficult to Remove

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT M.R.I. ISP. POST THE PROCEDURE ON (b)(6) 2026, DURING THE CATHETER REPLACEMENT PROCEDURE THE SEGMENT FROM THE FRACTURE POINT TO THE CATHETER TIP COULD NOT BE RETRIEVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 24596527 ↗
• MalfunctionMar 13, 2026Fracture; Material Separation; Suction Problem; Deformation Due to Compressive Stress; Naturally Worn

  ON (B)(6) 2022, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT ISP M.R.I. 3 YEARS 2 MONTHS AND 16 DAYS POST PROCEDURE, IT WAS REPORTED THAT ALTHOUGH THE PORT INITIALLY SHOWED NO BLOOD BACKFLOW DURING CONFIRMATION, THE CATHETER WAS LATER FOUND TO BE RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24593695 ↗
• MalfunctionMar 13, 2026Fracture; Deformation Due to Compressive Stress; Material Integrity Problem; Naturally Worn

  ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT ISP M.R.I. 6 MONTHS AND 26 DAYS POST PROCEDURE, THE PORT WAS REMOVED, AS THE CATHETER WAS FOUND TO BE DAMAGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589453 ↗
• MalfunctionMar 13, 2026Fracture; Material Integrity Problem

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE M.R.I. POWERPORT ISP. ON (B)(6) 2025, IT WAS REPORTED THAT DURING A SALINE INFUSION, THE PATIENT EXPERIENCED PAIN AND CATHETER DAMAGE WAS SUBSEQUENTLY CONFIRMED. THE DEVICE WAS REPLACED WITH A NEW PORT ON (B)(6) 2025. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24588916 ↗
• MalfunctionMar 13, 2026Fracture; Material Separation; Suction Problem; Deformation Due to Compressive Stress; Naturally Worn

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT M.R.I. ISP. POST PROCEDURE, ON (B)(6) 2025, THE CATHETER REPORTEDLY FRACTURED DURING A REPLACEMENT ATTEMPT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24587907 ↗