Deltec 21-2939-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10610586016745), received between Nov 4, 2021 and May 1, 2026 — classified as 1 death, 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K870866); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SIDE PORT CAP DISCONNECTED DURING INFUSION. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25060385 ↗
• MalfunctionSep 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A GRIPPER NEEDLE WAS PUNCTURED INTO THE PATIENT AT THE HOSPITAL AND THE ADMINISTRATION OF THE DRUG SOLUTION AND WHEN THE OPERATOR TRIED TO FLUSH THE SALINE SOLUTION FROM THE Y SITE WITH A LURE-SLIP SYRINGE, THE Y SITE WAS LOOSE AND THE SALINE SPLATTERED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20181112 ↗
• MalfunctionSep 9, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT, DURING THE USE OF THE PRODUCT, THE CUSTOMER NOTICED THE MEDICAL FLUID WAS UNABLE TO BE INFUSED FROM THE SYRINGE TO THE NEEDLE; IT COULD NOT BE DRAWN. THE CUSTOMER CHECKED THE SYRINGE AND CONFIRMED THAT THE PLUNGER MOVED WITHOUT DIFFICULTY; THEREFORE, IT IS SUSPECTED THAT THERE IS AN ANOMALY WITH THE NEEDLE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397423 ↗
• DeathNov 4, 2021Disconnection; Disconnection

  SMITHS MEDICAL RECEIVED INFORMATION THAT ON (B)(6) 2021 WHILE USING A GRIPPER PLUS NAC, ALONG WITH A MEDICON" IMPLANTABLE PORT, THE GRIPPER DEVICE WAS DISCONNECTED FROM THE NIPRO SURE PLUG" MATING COMPONENT. IT WAS REPORTED THAT AIR WAS DRAWN INTO THE CONNECTION PART, RESULTING IN AN AIR EMBOLI IN THE PATIENT. THE PATIENT EXPIRED ON (B)(6) 2021. CAUSE OF DEATH WAS CEREBRAL INFARCTION. PHYSICIAN INFORMED THAT A CASUAL RELATIONSHIP BETWEEN PATIENT DEATH AND THE AIR EMBOLISM CANNOT BE DENIED. NO LOT NUMBER WAS PROVIDED, AND THE DEVICE WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Air Embolism; Ischemia Stroke

  MAUDE report 12752756 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K870866. One submission often covers many models, so check the product and lot details in each record.

• Z-0189-2020 · Jul 8, 2019 · Terminated
  GRIPPER Needles sold individually. Labeled as the following item descriptions: 1. NDL, GRIPPER, 22G X 1" (25MM), 12/BX; 2. NDL, GRIPPER, 22G X 1.25" (32MM), 12/BX; 3. NDL