Deltec 21-4471-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10610586032745), received between Dec 12, 2017 and Jun 23, 2026 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K072657); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2026Contamination

  IT WAS REPORTED THAT DURING NEEDLE INSERTION, THE PORT-A-CATH IMPLANTABLE ACCESS PORT, A WHITE FLAKE WAS NOTICED DURING ASPIRATION ON THE VENOUS PORT AND NO LONGER USED. THE PATIENT REQUIRED REPLACEMENT OF THE VENOUS PORT AND UNDERWENT ADDITIONAL SURGERY IN WHICH THESE FLAKES WERE FOUND. THERE WAS PATIENT INVOLVEMENT; HOWEVER, UNKNOWN HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25598031 ↗
• MalfunctionApr 13, 2026Material Separation

  IT WAS REPORTED THAT THE CATHETER RUPTURED, AND A FRAGMENT MIGRATED AND BECAME LODGED IN THE ATRIUM OF THE HEART. AS A RESULT, THE PATIENT REQUIRED TRANSFER TO A CITY HOSPITAL FOR REMOVAL OF THE RETAINED CATHETER FRAGMENT. THE TREATING FACILITY EMPLOYS EXPERIENCED SURGEONS AND HAD NOT PREVIOUSLY ENCOUNTERED THIS TYPE OF COMPLICATION. THE RUPTURED CATHETER WAS REMOVED ON MARCH 24. THE CATHETER HAD ORIGINALLY BEEN IMPLANTED ON NOVEMBER 15, 2024.THERE WAS PATIENT INVOLVEMENT AND PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24860653 ↗
• InjuryOct 28, 2025Defective Component; Defective Component

  IT WAS STATED THAT THE PATIENT HAS A BROKEN FRAGMENT OF PORT-A-CATH ON THE LEFT SIDE OF THE CHEST. DURING AN IMAGING TEST, IT WAS FOUND THAT THE TIP OF THE PORT-A-CATH IS IN AN EXTRAVASCULAR POSITION AND IS SHORT (10 CM INSTEAD OF THE USUAL 20 CM). REMOVAL OF THE PORT-A-CATH WAS ATTEMPTED IN THE OPERATING ROOM AND THE REMOVAL WAS INCOMPLETE AS THE DISTAL END WAS NOT RETRIEVED. A SCAN CONFIRMED THAT THE CATHETER TIP IS POSITIONED IN THE PATIENT'S RIGHT VENTRICLE FOR WHICH A HEMODYNAMIC ASSESSMENT AND A POSSIBLE CARDIAC SURGERY WILL BE DONE TO REMOVE THE REMAINING PORTION OF THE CATHETER. THERE WAS PATIENT INVOLVEMENT AND PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 23402821 ↗
• MalfunctionJul 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE CATHETER RUPTURED INSIDE THE PATIENT. THE DISTAL PART WAS REMOVED FROM THE PATIENT WITH ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412414 ↗
• MalfunctionNov 27, 2019Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  INFORMATION WAS RECEIVED INDICATING THAT A 7 CM LEAK OCCURRED TO A SMITHS MEDICAL DELTEC® PORT-A-CATH®II IMPLANTABLE ACCESS SYSTEM. IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING SHOULD PAIN. AN X-RAY WAS ORDERED AND REVEALED A LEAK UNDER THE CORRESPONDING CLAVICLE. THE PORT WAS EXPLANTED AND REPLACED. THE PHYSICIAN REPORTED THAT A HOLE IS MADE NEXT TO THE PORT ENABLE TO GET THE GUIDEWIRE IN FOR INSERTION. THERE WERE NO FURTHER REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: Pain

  MAUDE report 9386749 ↗
• InjurySep 24, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE DEVICE WAS CRACKED IN TWO PLACES. THIS ISSUE WAS CONFIRMED VIA A LINOGRAM. THE PATIENT EXPERIENCED INFILTRATION ABOVE THE PORT AS RESULT OF THE PRODUCT PROBLEM. THE PATIENT REPORTED FEELING A BURNING SENSATION. THE PORT WAS SUBSEQUENTLY EXPLANTED ON (B)(6) 2019. IT WAS ALSO REPORTED THAT THIS INCIDENT REQUIRED THE INSERTION OF A PICC LINE IN ORDER TO CONTINUE TREATMENT. THE PATIENT'S TREATMENT WAS DELAYED BY ONE DAY AS A RESULT OF THIS. NO PATIENT INJURY OR FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: Burning Sensation

  MAUDE report 9112164 ↗
• InjurySep 13, 2019Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT WHILE A SMITHS MEDICAL IMPLANTABLE PORT WAS IN USE, NO REFLUX OCCURRED. XRAY HAS SHOWN A LEFT-SIDED, DYSFUNCTIONAL PORT WITH A SMALL DEFECT AT THE PROXIMAL END OF THE CATHETER. LEAKAGE OCCURRED TO SURROUNDING TISSUE WHERE CATHETER RUNS UNDER THE CLAVICLE. AS A RESULT, THE DEVICE WAS THEN REMOVED.

  Patient problems: Infiltration into Tissue

  MAUDE report 9037967 ↗
• InjuryFeb 16, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EXPLANTING DOCTOR NOTICED HOLES IN THE CATHETER OF A DELTEC® PORT-A-CATH®II POWER P.A.C. IMPLANTABLE ACCESS SYSTEM. ISSUES WITH THE CATHETER HAD TO BE EXPLANTED WHEN ONE PATIENT COMPLAINED OF PAIN. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS OCCURRENCE.

  Patient problems: Pain

  MAUDE report 7278792 ↗
• InjuryFeb 16, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EXPLANTING DOCTOR NOTICED HOLES IN THE CATHETER OF A DELTEC® PORT-A-CATH®II POWER P.A.C. IMPLANTABLE ACCESS SYSTEM. ISSUES WITH THE CATHETER HAD TO BE EXPLANTED WHEN ONE PATIENT COMPLAINED OF PAIN. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS OCCURRENCE.

  Patient problems: Pain

  MAUDE report 7278791 ↗
• MalfunctionFeb 16, 2018Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE EXPLANTING DOCTOR NOTICED HOLES IN THE CATHETER OF A DELTEC® PORT-A-CATH®II POWER P.A.C. IMPLANTABLE ACCESS SYSTEM. ISSUES WITH THE CATHETER HAD TO BE EXPLANTED WHEN ONE PATIENT COMPLAINED OF PAIN. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS OCCURRENCE.

  Patient problems: Pain

  MAUDE report 7278787 ↗
• InjuryFeb 16, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EXPLANTING DOCTOR NOTICED HOLES IN THE CATHETER OF A DELTEC® PORT-A-CATH®II POWER P.A.C. IMPLANTABLE ACCESS SYSTEM. ISSUES WITH THE CATHETER HAD TO BE EXPLANTED WHEN ONE PATIENT COMPLAINED OF PAIN. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS OCCURRENCE.

  Patient problems: Pain

  MAUDE report 7278786 ↗
• InjuryDec 12, 2017Hole In Material; Hole In Material

  INFORMATION WAS RECEIVED INDICATING THAT AT THE END OF THERAPY THE EXPLANTING DOCTOR NOTICED HOLES IN THE CATHETER OF THIS PORT. THE PORT HAD TO BE EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7110175 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072657. One submission often covers many models, so check the product and lot details in each record.

• Z-2499-2020 · Jun 11, 2020 · Terminated
  PORT-A-CATH II POWER P.A.C. Low Profile" system.
• Z-0190-2020 · Jul 8, 2019 · Terminated
  GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: 1. TRAY, PAC, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 2.