BardPort M.R.I., Groshong 0602830Recalls & reported problems

Summary

The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 00801741025716), received between Jun 4, 2018 and Sep 24, 2026 — classified as 1 death, 47 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Fracture” (60 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 108 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Fracture

  On (b)(6) 2026, a patient underwent a port placement procedure using the M.R.I. Implantable Port. During the procedure, the catheter fractured while being inserted through the introducer sheath. The procedure was completed using another device. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877976 ↗
• 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 50144045 ↗
• MalfunctionJul 3, 2026Reflux within Device; Failure to Advance; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PORT PLACEMENT PROCEDURE VIA THE RIGHT INTERNAL JUGULAR VEIN USING AN M.R.I. IMPLANTABLE PORT. DURING THE PROCEDURE, DIFFICULTY WAS ENCOUNTERED WHILE ATTEMPTING TO INSERT THE GUIDEWIRE DUE TO THE UNSUITABLE SHAPE OF THE WIRES SHEATH, WHICH HINDERED THUMB ASSISTED INSERTION AND MADE IT CHALLENGING TO OVERCOME THE NATURAL BEND AT THE TIP. THIS LED TO PROCEDURAL DIFFICULTY AND INCREASED TENSION, AS THE DILATOR WAS POSITIONED IN THE VEIN, RESULTING IN UNDESIRABLE BLOOD REFLUX. WITH SIGNIFICANT EFFORT, THE GUIDEWIRE WAS EVENTUALLY INSERTED BUT BECAME DIFFICULT TO ADVANCE WITHOUT AN APPARENT CAUSE, REQUIRING FORCEFUL MANIPULATION. ALTHOUGH ADVANCEMENT WAS ACHIEVED, RETRIEVAL OF THE GUIDEWIRE WAS NOT POSSIBLE, AS NO SEGMENT WAS ACCESSIBLE FOR WITHDRAWAL. FLUOROSCOPY REVEALED THAT THE GUIDEWIRE WAS POSITIONED UNSTABLY AT THE TIP, POSING A HIGH RISK OF DETACHMENT AND POTENTIAL EMBOLISM. THE ENTIRE SYSTEM WAS CAREFULLY RETRACTED UNDER DYNAMIC FLUOROSCOPY WITHOUT WIRE DETACHMENT; HOWEVER, THE GUIDEWIRE KINKED, RENDERING THE PORT IMPLANTATION UNSUCCESSFUL. THE DEVICE WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25703985 ↗
• DeathJun 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. IT WAS FURTHER REPORTED THAT THE PATIENT EVENTUALLY EXPIRED. HOWEVER, THE CAUSE OF DEATH WAS NOT REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 25635197 ↗
• InjuryJun 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 25592796 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported through the litigation process that, sometime after the port placement procedure, a port malfunction occurred, and the patient was diagnosed with an unspecified infection. However, the current status of the patient remains unknown.

  Patient problems: Unspecified Infection

  MAUDE report 24685693 ↗
• MalfunctionMar 23, 2026Fracture; Material Separation; Material Protrusion/Extrusion

  ON (B)(6) 2026, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE M.R.I. PORT. POST THE PROCEDURE ON (B)(6) 2026, IT WAS NOTED THAT THE RESERVOIR CHAMBER HAD COMPLETELY BROKEN OFF FROM THE PORT AND THE RESERVOIR ALSO DISLODGED FROM THE PORT SEPTUM. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT, SO THE CATHETER WAS REMOVED. THERE WAS NO PATIENT REPORTED INJURY.

  Patient problems: Discomfort

  MAUDE report 24659622 ↗
• 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 THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24659465 ↗
• InjuryMar 16, 2026Fracture; Obstruction of Flow

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

  Patient problems: Obstruction/Occlusion

  MAUDE report 24602919 ↗
• MalfunctionMar 5, 2026Fracture

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

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

  MAUDE report 24519362 ↗
• InjuryFeb 26, 2026Fracture; Material Separation; Migration

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

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24451410 ↗
• MalfunctionFeb 18, 2026Insufficient Device Problem Information

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PORT HAD ALLEGEDLY MALFUNCTIONED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377619 ↗
• MalfunctionFeb 13, 2026Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24331192 ↗
• MalfunctionDec 23, 2025Fracture; Failure to Advance; Fracture; Failure to Advance

  ON (B)(6) 2025, A PATIENT UNDERWENT PORT PLACEMENT PROCEDURE USING MRI IMPLANTABLE PORT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DILATOR SHEATH WAS ALLEGEDLY FOUND DAMAGED, WHICH PREVENTED THE CATHETER FROM ADVANCING INSIDE IT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23874977 ↗
• MalfunctionDec 18, 2025Difficult to Flush; Suction Problem; Difficult to Flush; Suction Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE MRI PORT. IT WAS REPORTED BY SURGEON THAT AFTER PUNCTURING, THE NEEDLE DID NOT ASPIRATE OR INJECT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23836959 ↗
• InjuryDec 17, 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 23825513 ↗
• InjuryDec 17, 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, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23825508 ↗
• InjuryDec 12, 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. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23786931 ↗
• InjuryNov 24, 2025Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PORT CATHETER FRACTURED AND MIGRATED. FURTHER IT WAS REPORTED THE PATIENT WAS INJURED AND THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 23628565 ↗
• InjuryNov 20, 2025Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PORT CATHETER FRACTURED AND MIGRATED. FURTHER IT WAS REPORTED THE PATIENT WAS INJURED AND THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 23603151 ↗
• InjuryOct 31, 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 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 23434228 ↗
• MalfunctionAug 19, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22839295 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY EIGHTY-FOUR MONTHS AND TWENTY-FIVE DAYS POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED WITH THROMBOSIS AND CHEST PAIN. REPORTEDLY, THE PORT WAS REMOVED. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Chest Pain; Thrombosis/Thrombus

  MAUDE report 22768622 ↗
• 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 22740489 ↗
• MalfunctionJul 29, 2025Obstruction of Flow; Obstruction of Flow

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22641310 ↗