Deltec 21-4055-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10610586023552), received between Oct 23, 2017 and Mar 24, 2026 — classified as 14 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (12 reports).

6 other recalls cover devices cleared under the same FDA submission (K962695); 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER CONNECTING THE CATHETER TO THE PORT, THE PHYSICIAN VERIFIED THE SYSTEM'S PERMEABILITY BY INJECTING AND ASPIRATING SOLUTION AND A LEAK WAS IDENTIFIED IN THE SEPTUM RING. THERE WAS PATIENT INVOLVEMENT, AND NO HARM AS RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673710 ↗
• MalfunctionSep 20, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE DEVICE LEAKED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15453912 ↗
• MalfunctionSep 12, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE DEVICE LEAKED FROM THE CATHETER ON THREE (3) OCCASIONS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15406492 ↗
• MalfunctionMar 4, 2022Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT THE DOCTOR WAS ABLE TO FLUSH THE PORT, HOWEVER IT DID NOT POUR BACK BLOOD, ONLY BUBBLES. DEVICE MALFUNCTIONED AND THE DOCTOR HAD TO US ANOTHER PORT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13666542 ↗
• InjuryMar 20, 2018Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED INDICATING THAT 10-20 DAYS FOLLOWING IMPLANT OF A SMITHS MEDICAL PORT-A-CATH®II IMPLANTABLE ACCESS SYSTEMS THE SKIN IS REPORTED TO RUPTURE CAUSING THE CHAMBER TO COME OUT. SUBSEQUENTLY, THE PATIENT WAS BROUGHT TO SURGERY FOR INTERVENTION WHICH WAS REPORTED TO DELAY CHEMOTHERAPY TREATMENT. NO FURTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Rupture

  MAUDE report 7353324 ↗
• InjuryMar 19, 2018Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED INDICATING THAT 10-20 DAYS FOLLOWING IMPLANT OF A SMITHS MEDICAL PORT-A-CATH®II IMPLANTABLE ACCESS SYSTEMS THE SKIN IS REPORTED TO RUPTURE CAUSING THE CHAMBER TO COME OUT. SUBSEQUENTLY, THE PATIENT WAS BROUGHT TO SURGERY FOR INTERVENTION WHICH WAS REPORTED TO DELAY CHEMOTHERAPY TREATMENT. NO FURTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Rupture

  MAUDE report 7350679 ↗
• InjuryMar 19, 2018Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED INDICATING THAT 10-20 DAYS FOLLOWING IMPLANT OF A SMITHS MEDICAL PORT-A-CATH®II IMPLANTABLE ACCESS SYSTEMS THE SKIN IS REPORTED TO RUPTURE CAUSING THE CHAMBER TO COME OUT. SUBSEQUENTLY, THE PATIENT WAS BROUGHT TO SURGERY FOR INTERVENTION WHICH WAS REPORTED TO DELAY CHEMOTHERAPY TREATMENT. NO FURTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Rupture

  MAUDE report 7350673 ↗
• InjuryMar 19, 2018Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED INDICATING THAT 10-20 DAYS FOLLOWING IMPLANT OF A SMITHS MEDICAL PORT-A-CATH®II IMPLANTABLE ACCESS SYSTEMS THE SKIN IS REPORTED TO RUPTURE CAUSING THE CHAMBER TO COME OUT. SUBSEQUENTLY, THE PATIENT WAS BROUGHT TO SURGERY FOR INTERVENTION WHICH WAS REPORTED TO DELAY CHEMOTHERAPY TREATMENT. NO FURTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Rupture

  MAUDE report 7350666 ↗
• InjuryMar 19, 2018Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED INDICATING THAT 10-20 DAYS FOLLOWING IMPLANT OF A SMITHS MEDICAL PORT-A-CATH®II IMPLANTABLE ACCESS SYSTEMS THE SKIN IS REPORTED TO RUPTURE CAUSING THE CHAMBER TO COME OUT. SUBSEQUENTLY, THE PATIENT WAS BROUGHT TO SURGERY FOR INTERVENTION WHICH WAS REPORTED TO DELAY CHEMOTHERAPY TREATMENT. NO FURTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Rupture

  MAUDE report 7350663 ↗
• InjuryMar 19, 2018Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED INDICATING THAT 10-20 DAYS FOLLOWING IMPLANT OF A SMITHS MEDICAL PORT-A-CATH®II IMPLANTABLE ACCESS SYSTEMS THE SKIN IS REPORTED TO RUPTURE CAUSING THE CHAMBER TO COME OUT. SUBSEQUENTLY, THE PATIENT WAS BROUGHT TO SURGERY FOR INTERVENTION WHICH WAS REPORTED TO DELAY CHEMOTHERAPY TREATMENT. NO FURTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Rupture

  MAUDE report 7350660 ↗
• MalfunctionMar 19, 2018Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED INDICATING THAT 10-20 DAYS FOLLOWING IMPLANT OF A SMITHS MEDICAL PORT-A-CATH®II IMPLANTABLE ACCESS SYSTEMS THE SKIN IS REPORTED TO RUPTURE CAUSING THE CHAMBER TO COME OUT. SUBSEQUENTLY, THE PATIENT WAS BROUGHT TO SURGERY FOR INTERVENTION WHICH WAS REPORTED TO DELAY CHEMOTHERAPY TREATMENT. NO FURTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Rupture

  MAUDE report 7350658 ↗
• InjuryMar 19, 2018Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED INDICATING THAT 10-20 DAYS FOLLOWING IMPLANT OF A SMITHS MEDICAL PORT-A-CATH®II IMPLANTABLE ACCESS SYSTEMS THE SKIN IS REPORTED TO RUPTURE CAUSING THE CHAMBER TO COME OUT. SUBSEQUENTLY, THE PATIENT WAS BROUGHT TO SURGERY FOR INTERVENTION WHICH WAS REPORTED TO DELAY CHEMOTHERAPY TREATMENT. NO FURTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Rupture

  MAUDE report 7350648 ↗
• InjuryMar 19, 2018Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED INDICATING THAT 10-20 DAYS FOLLOWING IMPLANT OF A SMITHS MEDICAL PORT-A-CATH®II IMPLANTABLE ACCESS SYSTEMS THE SKIN IS REPORTED TO RUPTURE CAUSING THE CHAMBER TO COME OUT. SUBSEQUENTLY, THE PATIENT WAS BROUGHT TO SURGERY FOR INTERVENTION WHICH WAS REPORTED TO DELAY CHEMOTHERAPY TREATMENT. NO FURTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Rupture

  MAUDE report 7350647 ↗
• InjuryMar 19, 2018Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED INDICATING THAT 10-20 DAYS FOLLOWING IMPLANT OF A SMITHS MEDICAL PORT-A-CATH®II IMPLANTABLE ACCESS SYSTEMS THE SKIN IS REPORTED TO RUPTURE CAUSING THE CHAMBER TO COME OUT. SUBSEQUENTLY, THE PATIENT WAS BROUGHT TO SURGERY FOR INTERVENTION WHICH WAS REPORTED TO DELAY CHEMOTHERAPY TREATMENT. NO FURTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Rupture

  MAUDE report 7350645 ↗
• InjuryDec 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE "WOUND OF POCKET" OF A PORT-A-CATH® II IMPLANTABLE ACCESS SYSTEM WOULDN'T HEAL. THE PATIENT IS STILL UNDER TREATMENT.

  Patient problems: Post Operative Wound Infection

  MAUDE report 7126677 ↗
• InjuryDec 18, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE TUBE OF A PORT-A-CATH® II IMPLANTABLE ACCESS SYSTEM RUPTURED. THE PORT WAS EXPLANTED DUE TO THE RUPTURE. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7126674 ↗
• InjuryDec 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE "WOUND OF POCKET" OF A PORT-A-CATH® II IMPLANTABLE ACCESS SYSTEM WOULDN'T HEAL. THE PATIENT EXPIRED.

  Patient problems: Death

  MAUDE report 7126662 ↗
• InjuryDec 18, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE TUBE OF A PORT-A-CATH® II IMPLANTABLE ACCESS SYSTEM RUPTURED. THE PORT WAS EXPLANTED DUE TO THE RUPTURE. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7124996 ↗
• InjuryOct 23, 2017Difficult to Remove; Retraction Problem; Difficult to Remove; Retraction Problem

  IT WAS REPORTED THAT THE SMITHS MEDICAL PORT-A-CATH® IMPLANTABLE VENOUS ACCESS SYSTEMS GUIDE-WIRE COULD NOT BE PULLED OUT OF THE VEIN AFTER PUNCTURE WAS COMPLETE. ULTRASOUND WAS USED TO CONFIRM CORRECT PUNCTURE SITE BUT IT WAS REQUIRED THAT THE NURSE CHANGE OUT THE SMITHS MEDICAL DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6969903 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K962695. One submission often covers many models, so check the product and lot details in each record.

• Z-0866-04 · Mar 29, 2004 · Terminated
  Port-A-Cath II Polysulfone/Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 Fr Introducer Set, REF 21-4055-24
• Z-0869-04 · Mar 29, 2004 · Terminated
  Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 Fr Introducer Set, REF 21-4083-24
• Z-0867-04 · Mar 29, 2004 · Terminated
  Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 Fr Introducer Set, REF 21-4071-24
• Z-0870-04 · Mar 29, 2004 · Terminated
  Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 Fr Introducer Set, REF 21-4085-2
• Z-0868-04 · Mar 29, 2004 · Terminated
  Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 Fr Introducer Set, REF 21-4073
• Z-0876-04 · Mar 29, 2004 · Terminated
  Port-A-Cath II Fluoro-Free Low Profile Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., and with CATH-FINDER Sensor Wire, REF 21-4685-24