Deltec 21-3468-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10610586033070), received between Mar 4, 2021 and Sep 8, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (3 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Obstruction of Flow

  It was reported that during infusion with Deltec Gripper Plus Needle, the gripper was clamped and did not infuse. There was patient involvement and no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50668054 ↗
• MalfunctionSep 7, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50657262 ↗
• MalfunctionSep 7, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50652286 ↗
• MalfunctionMar 26, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT THE SAFETY DEVICE MALFUNCTIONED WHILE DE-ACCESSING THE PORT. THE REGISTERED EXPERIENCED A NEEDLE STICK AS A RESULT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 24700898 ↗
• MalfunctionNov 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE THE NORMAL SALINE WAS BEING FLUSHED, A LEAKING WAS NOTICED AT THE POINT OF BIFURCATION OF THE DEVICE. THE NURSE STOPPED THE INFUSION PROCEDURE AND DE-ACCESSED THE PORT. THE NURSE THEN RE-ACCESSED THE PORT WITH A NEW HUBER NEEDLE. IT WAS NOTED THAT THERE WAS NO MORE LEAKING ON THE DEVICE FOR THE DURATION OF THE PATIENT'S HOSPITALIZATION. THE ORIGINAL INTENDED PROCEDURE WAS SODIUM BICARBONATE FOR URINE PH RUNNING AT ORDERED RATE. THERE WAS PATIENT INVOLVEMENT, BUT UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20736355 ↗
• MalfunctionSep 5, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE NEEDLE WOULD NOT FULLY RETRACT AND APPROXIMATELY 2-3MM OF THE NEEDLE REMAINS EXPOSED BELOW THE PADDED EDGE. THE NURSE PULLED AS HARD AS SHE COULD AND FAILED TO HEAR THE CLICK ON THE NEEDLE-LOCKING MECHANISM. AFTER REMOVING THE SAFETY NEEDLE FROM THE PORT, SHE WAS STUCK WITH THE NEEDLE, AS IT NEVER LOCKED IN PLACE. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20148512 ↗
• MalfunctionJul 18, 2024Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT WHILE USING THE DEVICE THE SAFETY DEVICE HAD ENGAGED OVER THE NEEDLE HOWEVER THE NEEDLE REMAINED EXPOSED LEADING TO A NEEDLE STICK. THERE WAS PATIENT INVOLVEMENT AND NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19774291 ↗
• MalfunctionSep 14, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THE DEVICE HAD RESISTANCE TO FLUSHING DUE TO KINKING. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15422934 ↗
• MalfunctionSep 12, 2022Flushing Problem; Priming Problem; Flushing Problem; Priming Problem

  IT WAS REPORTED THAT IT WAS DIFFICULT TO FLUSH/PRIME WITH SALINE. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15406447 ↗
• MalfunctionSep 12, 2022Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT THE DEVICE IS UNABLE TO FLUSH THROUGH THE NEEDLE DUE TO HIGH PRESSURE RESISTANCE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15405640 ↗
• MalfunctionSep 9, 2022Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT, WHEN THE NURSE ACCESSED THE PORT FOR LAB DRAW, THE NURSE WAS UNABLE TO ASPIRATE BLOOD AND ONLY A SMALL AMOUNT WAS OBTAINED WITH A SYRINGE FULL OF AIR. THE PATIENT WAS RE-ACCESSED WITH A NEW NEEDLE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397415 ↗
• MalfunctionMay 19, 2021Suction Problem; Improper Flow or Infusion; Suction Problem; Improper Flow or Infusion

  INFORMATION RECEIVED A SMITHS MEDIAL IMPLANTABLE PORTS/DELTEC GRIPPER PLUS POWER NEEDLES MALFUNCTIONED. REPORTED A NURSE WAS COMPLETING A BLOOD DRAW AND GOT AIR BUBBLES WITH FLEX OF BLOOD IN SYRINGE. THE NURSE THEN TRIED TO TIGHTEN THE CONNECTIONS AND USED MULTIPLE SYRINGES TO ASPIRATE FROM THE Y- SITE CONNECTION OF THE HUBER NEEDLE TUBING AND STILL PULLED BACK AIR BUBBLES INSTEAD OF BLOOD. IT WAS REPORTED THEN RE ACCESS OF GRIPPER TO THE PATIENT WITH A DIFFERENT NEEDLE HUBER SET AND WAS THEN ABLE TO GET BLOOD TO RETURN EASILY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11852744 ↗
• MalfunctionApr 16, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  NURSE WAS COMPLETING A BLOOD DRAW AND GOT AIR BUBBLES WITH FLEX OF BLOOD IN SYRINGE. THE NURSE THEN TRIED TO TIGHTEN THE CONNECTIONS AND USED MULTIPLE SYRINGES TO ASPIRATE FROM THE Y- SITE CONNECTION OF THE HUBER NEEDLE TUBING AND STILL PULLED BACK AIR BUBBLES INSTEAD OF BLOOD. HAD TO RE- ACCESS PATIENT WITH A DIFFERENT GRIPPER NEEDLE HUBER SET AND THE BLOOD RETURN WAS EASILY OBTAINED.

  Patient problems: Insufficient Information

  MAUDE report 11682872 ↗
• MalfunctionMar 8, 2021Suction Problem; Suction Problem

  IT WAS REPORTED DURING ASPIRATION, THE DEVICE DREW BACK AIR WITH SPURTS OF BLOOD. NO PATIENT INJURY OR FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11440345 ↗
• MalfunctionMar 4, 2021Leak/Splash; Leak/Splash

  17-MARCH-2021: MEDWATCH RECEIVED. 22-MARCH: DATE OF EVENT UPDATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11418721 ↗

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.