DIGNITYRecalls & reported problems across all models
Medical Components, Inc. · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one DIGNITY model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 1
We found 10 models of DIGNITY by Medical Components, Inc. in the FDA's device registry (GUDID). Together they are named in 12 adverse event reports in the FDA's MAUDE database, received between Dec 6, 2019 and Oct 31, 2025 — classified as 3 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
DIGNITY recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 13, 2021Open, Classified
The 5F Dignity CT Port kits were packaged with the incorrect size port. The kits include a 6.6F port instead of the correct 5F port. The inability to connect the catheter lumen to the port stem because of the incorrect size may not be noted until well into the procedure, after the catheter lumen is placed in the vessel. An alternate port will need to be obtained prolonging the procedure. A prolonged insertion procedure increases any risk associated with a surgical procedure.
Z-1184-2021 · Root cause: Employee error · Recall details · FDA record ↗
Most reported DIGNITY problems
Device problems
- Break3
- Leak/Splash3
- Fracture2
- Component Incompatible1
- Detachment of Device or Device Component1
- Disconnection1
- Insufficient Device Problem Information1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Swelling/ Edema3
- Foreign Body In Patient2
- No Known Impact Or Consequence To Patient2
- Extravasation1
- Foreign Body Embolism1
- Insufficient Information1
- Pain1
DIGNITY models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DIGNITY® MRDP50AXSPORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 recall3 reports
- DIGNITY® MRCTI50041MPPORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
- DIGNITY® MRDP80ALNPORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
- DIGNITY® MRDP80AMNPORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
- DIGNITY® MRDP80AMSPORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
- DIGNITY® MIDP66AXSPORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
- DIGNITY® MRDP50PLSPORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
- DIGNITY® MRDP66AMNPORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
- DIGNITY® MRDP66PLNPORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
- DIGNITY® MRDP66PLSPORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
Recent DIGNITY adverse event reports
The 12 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionOct 31, 2025Leak/Splash; Leak/Splash
PATIENT HAD A 5FR PORT WHICH HAD BEEN IMPLANTED ON (B)(6) 2024 AND HAD BEEN IN PLACE FOR 482 DAYS FOR TREATMENT. ON (B)(6) 2025, PORT WAS TO BE ACCESSED AND IT WAS OBSERVED BY NUMEROUS RNS THAT THERE APPEARED TO BE EXTRAVASATION OF FLUIDS AND THE SITE WAS SWOLLEN. A DYE STUDY WAS ORDERED AND PERFORMED ON (B)(6) AT 1236. DURING THE DYE STUDY, ACCESS WAS ACHIEVED VIA HUBER NEEDLE BUT NO BLOOD RETURN WAS NOTED, CONTRAST WAS INJECTED AND IT WAS DEMONSTRATED THAT THE CONTRAST WAS FILLING THE PORT BODY AND SURROUNDING POCKET BUT NOT ENTERING THE CATHETER. PATIENT WAS BROUGHT TO SEDATION TO HAVE PORT REMOVED ON 10/10 IN THE AFTERNOON AND PORT WAS TO BE REPLACED. DURING REMOVAL, UPON EXCISION OF THE BODY OF THE PORT FROM THE PATIENT, IT WAS OBSERVED THAT THERE IS A PIN HOLE IN THE BACK OF THE PORT BODY, THROUGH THE PRINTED T ON THE BACK. PORT WAS REPLACED WITH SAME SIZE AND EXCISED IMPLANT WAS SAVED FOR DEFECT REPORTING.
Patient problems: Swelling/ Edema
MAUDE report 23434973 ↗MalfunctionOct 23, 2025Material Puncture/Hole; Material Puncture/Hole
PATIENT SEEN FOR A FLOW STUDY OF HER PORT. IR PA (B)(6) PERFORMED STUDY THAT SHOWED LEAKING OF THE CONTRAST FROM POSTERIOR PART OF THE PORT RESERVOIR. PATIENT TO OPERATING ROOM ON (B)(6) FOR PORT REMOVAL AND NEW PORT PLACEMENT. VISIBLE AND PALPABLE "HOLE" IN HARD PLASTIC BACKING OF PORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23371833 ↗MalfunctionApr 28, 2025Disconnection; Disconnection
IR BROUGHT PATIENT FOR PORT CHECK. PORT NOT GIVING BLOOD RETURN. CATHETER WAS DETACHED FROM PORT UNDER FLOURO. PORT, LOCKING MECHANISM, AND CATHETER WERE RETRIEVED FROM PATIENT. LOCKING COLLAR WAS ON PORT. NOT SURE IF CATHETER WAS LOCKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21917508 ↗MalfunctionMar 4, 2025Break; Break
DEVICE WAS BROKEN (LUMEN BROKE) WHICH WAS WHY THE PROCEDURE WAS NEEDED FOR PORT PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21515795 ↗InjuryOct 22, 2024Fracture; Migration or Expulsion of Device; Fracture; Migration or Expulsion of Device
PATIENT PRESENTED TO VIR (VASCULAR AND INTERVENTIONAL RADIOLOGY) FOR RIGHT CHEST WALL PORT REMOVAL. UPON IMAGING IN VIR NOTED THAT MEDICAL DEVICE WAS BROKEN AND CATHETER WAS FREE FLOATING IN THE PATIENT'S HEART/CHEST AND HUB WAS MAINTAINED IN RIGHT CHEST WALL.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 20501484 ↗MalfunctionOct 21, 2024Leak/Splash; Leak/Splash
WHEN THE PORT WAS ACCESSED AND FLUSHED IT WAS NOTED TO LEAK BLOOD AND IV FLUIDS FROM THE ACCESS SITE. THE TISSUE AROUND THE PORT ALSO NOTED TO SWELL WITH FLUIDS FLUSHED. THE PORT WAS REMOVED AND INSPECTED. A ROUND HOLE WAS NOTED ON THE BACK SIDE OF THE PORT LOCATED RIGHT BETWEEN THE LETTERS "C" AND "T".
Patient problems: Swelling/ Edema
MAUDE report 20494552 ↗InjuryDec 11, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
PATIENT PORT NOTED TO BE LEAKING AND DIFFICULT TO FLUSH. VENOUS PORT FLUORO INJECTION DONE, SHOWING THE PORT TUBING BROKE OFF OF PORT DEVICE AND WAS EMBOLIZED IN THE RIGHT ATRIUM. FOREIGN BODY RETRIEVAL COMPLETED SUCCESSFULLY.
Patient problems: Foreign Body Embolism; Foreign Body In Patient
MAUDE report 18302662 ↗MalfunctionOct 18, 2022Leak/Splash; Leak/Splash
PORT WAS NOT WORKING, AND PATIENT HAD PAIN AND SWELLING AT SIGHT. WHEN PORT WAS REMOVED IT HAD A HOLE IN THE BACK OF IT.
Patient problems: Extravasation; Pain; Swelling/ Edema
MAUDE report 15623928 ↗InjuryApr 26, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
THE FACILITY SUBMITTED A VOLUNTARY EVENT REPORT STATING THERE WERE THREE BLOODSTREAM INFECTIONS IN ONCOLOGY PATIENTS WITH PORT OVER 18 DAY PERIOD. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 11723627 ↗MalfunctionDec 2, 2020Component Incompatible; Component Incompatible
THE DEVICE WAS BEING USED FOR AN ARM INSERTION. AFTER GAINING ACCESS, POSITIONING THE CATHETER, AND REMOVING THE PEEL-AWAY SHEATH, IT WAS DISCOVERED THAT THE PORT STEM WAS NOT COMPATIBLE WITH THE F SIZE OF THE CATHETER.
Patient problems: Thrombosis
MAUDE report 10934429 ↗MalfunctionAug 17, 2020Fracture; Fracture
PREVIOUS PORT-A-CATHETER WAS MALFUNCTIONING. A CRACK WAS NOTED UPON EXPLANTATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10415096 ↗MalfunctionDec 6, 2019Break; Break
PATIENT WAS HAVING PORT REMOVED. UPON REMOVAL THE DOCTOR HAD NOTICED THAT THE PLASTIC PORT CASING HAD CRACKED AND BROKEN IN TO TWO PIECES. THE DOCTOR NOTED THAT THE POCKET WAS CLEAN AND HEALTHY, NO DAMAGE TO THE PATIENT OR EVIDENCE OF ANY MEDICATION LEAKING FROM THE PORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9432218 ↗
Other Medical Components, Inc. products
All Medical Components, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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