Deltec 21-2764-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10610586025570), received between Jan 14, 2021 and Nov 3, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (13 reports).

1 other recall cover devices cleared under the same FDA submission (K021999); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PATIENT TREATMENT AT THE HOSPITAL, THE SAFETY NEEDLE FAILED TO MAKE THE USUAL CLICK WHEN THE NURSE ATTEMPTED TO REMOVE THE GRIPPER, AND THE NEEDLE WAS FOUND DETACHED FROM THE SYSTEM. THE CYTOSTATIC DRUG ADMINISTERED WAS UNKNOWN. A SIMILAR ISSUE OCCURRED THE PREVIOUS WEEK WITH ANOTHER GRIPPER, BUT IT WAS NOT REPORTED DUE TO LACK OF A SAMPLE. THE EVENT OCCURRED AFTER THE NEEDLE HAD BEEN CONNECTED TO THE PATIENT AND WAS BEING REMOVED TO CONCLUDE THE TREATMENT. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE EVENT REPORTED BUT WAS THERE WAS DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452574 ↗
• MalfunctionMay 22, 2025Complete Blockage; Obstruction of Flow; Complete Blockage; Obstruction of Flow

  IT WAS REPORTED THAT DURING THE CLINICAL NURSE IRRIGATED AND SEALED THE PRODUCT, THE BLOOD AT THE TIP OF THE PRODUCT COULD NOT BE FLUSHED MANY TIMES AND COLLECTED INSIDE THE CONNECTION BETWEEN THE NEEDLE TAIL AND THE CATHETER. THIS WAS THE CASE WITH MULTIPLE PRODUCTS USED IN A ROW. THERE WAS UNKNOWN PATIENT HARM REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22069198 ↗
• MalfunctionMay 22, 2025Complete Blockage; Obstruction of Flow; Complete Blockage; Obstruction of Flow

  IT WAS REPORTED THAT DURING THE CLINICAL NURSE IRRIGATED AND SEALED THE PRODUCT, THE BLOOD AT THE TIP OF THE PRODUCT COULD NOT BE FLUSHED MANY TIMES AND COLLECTED INSIDE THE CONNECTION BETWEEN THE NEEDLE TAIL AND THE CATHETER. THIS WAS THE CASE WITH MULTIPLE PRODUCTS USED IN A ROW. THERE WAS UNKNOWN PATIENT HARM REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22069084 ↗
• MalfunctionMay 22, 2025Complete Blockage; Obstruction of Flow; Complete Blockage; Obstruction of Flow

  IT WAS REPORTED THAT DURING THE CLINICAL NURSE IRRIGATED AND SEALED THE PRODUCT, THE BLOOD AT THE TIP OF THE PRODUCT COULD NOT BE FLUSHED MANY TIMES AND COLLECTED INSIDE THE CONNECTION BETWEEN THE NEEDLE TAIL AND THE CATHETER. THIS WAS THE CASE WITH MULTIPLE PRODUCTS USED IN A ROW. THERE WAS UNKNOWN PATIENT HARM REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22067709 ↗
• MalfunctionMay 22, 2025Complete Blockage; Obstruction of Flow; Complete Blockage; Obstruction of Flow

  IT WAS REPORTED THAT DURING THE CLINICAL NURSE IRRIGATED AND SEALED THE PRODUCT, THE BLOOD AT THE TIP OF THE PRODUCT COULD NOT BE FLUSHED MANY TIMES AND COLLECTED INSIDE THE CONNECTION BETWEEN THE NEEDLE TAIL AND THE CATHETER. THIS WAS THE CASE WITH MULTIPLE PRODUCTS USED IN A ROW. THERE WAS UNKNOWN PATIENT HARM REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22067672 ↗
• MalfunctionMay 22, 2025Complete Blockage; Obstruction of Flow; Complete Blockage; Obstruction of Flow

  IT WAS REPORTED THAT DURING THE CLINICAL NURSE IRRIGATED AND SEALED THE PRODUCT, THE BLOOD AT THE TIP OF THE PRODUCT COULD NOT BE FLUSHED MANY TIMES AND COLLECTED INSIDE THE CONNECTION BETWEEN THE NEEDLE TAIL AND THE CATHETER. THIS WAS THE CASE WITH MULTIPLE PRODUCTS USED IN A ROW. THERE WAS UNKNOWN PATIENT HARM REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22067638 ↗
• MalfunctionMay 22, 2025Complete Blockage; Obstruction of Flow; Complete Blockage; Obstruction of Flow

  IT WAS REPORTED THAT DURING THE CLINICAL NURSE IRRIGATED AND SEALED THE PRODUCT, THE BLOOD AT THE TIP OF THE PRODUCT COULD NOT BE FLUSHED MANY TIMES AND COLLECTED INSIDE THE CONNECTION BETWEEN THE NEEDLE TAIL AND THE CATHETER. THIS WAS THE CASE WITH MULTIPLE PRODUCTS USED IN A ROW. THERE WAS UNKNOWN PATIENT HARM REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22067585 ↗
• MalfunctionMay 22, 2025Complete Blockage; Obstruction of Flow; Complete Blockage; Obstruction of Flow

  IT WAS REPORTED THAT DURING THE CLINICAL NURSE IRRIGATED AND SEALED THE PRODUCT, THE BLOOD AT THE TIP OF THE PRODUCT COULD NOT BE FLUSHED MANY TIMES AND COLLECTED INSIDE THE CONNECTION BETWEEN THE NEEDLE TAIL AND THE CATHETER. THIS WAS THE CASE WITH MULTIPLE PRODUCTS USED IN A ROW. THERE WAS UNKNOWN PATIENT HARM REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22067556 ↗
• MalfunctionMay 22, 2025Complete Blockage; Obstruction of Flow; Complete Blockage; Obstruction of Flow

  IT WAS REPORTED THAT DURING THE CLINICAL NURSE IRRIGATED AND SEALED THE PRODUCT, THE BLOOD AT THE TIP OF THE PRODUCT COULD NOT BE FLUSHED MANY TIMES AND COLLECTED INSIDE THE CONNECTION BETWEEN THE NEEDLE TAIL AND THE CATHETER. THIS WAS THE CASE WITH MULTIPLE PRODUCTS USED IN A ROW. THERE WAS UNKNOWN PATIENT HARM REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22067523 ↗
• MalfunctionMay 22, 2025Complete Blockage; Obstruction of Flow; Complete Blockage; Obstruction of Flow

  IT WAS REPORTED THAT DURING THE CLINICAL NURSE IRRIGATED AND SEALED THE PRODUCT, THE BLOOD AT THE TIP OF THE PRODUCT COULD NOT BE FLUSHED MANY TIMES AND COLLECTED INSIDE THE CONNECTION BETWEEN THE NEEDLE TAIL AND THE CATHETER. THIS WAS THE CASE WITH MULTIPLE PRODUCTS USED IN A ROW. THERE WAS UNKNOWN PATIENT HARM REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22067444 ↗
• MalfunctionMay 21, 2025Complete Blockage; Obstruction of Flow; Complete Blockage; Obstruction of Flow

  IT WAS REPORTED THAT DURING THE CLINICAL NURSE IRRIGATED AND SEALED THE PRODUCT, THE BLOOD AT THE TIP OF THE PRODUCT COULD NOT BE FLUSHED MANY TIMES AND COLLECTED INSIDE THE CONNECTION BETWEEN THE NEEDLE TAIL AND THE CATHETER. THIS WAS THE CASE WITH MULTIPLE PRODUCTS USED IN A ROW. THERE WAS UNKNOWN PATIENT HARM REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22065473 ↗
• MalfunctionMay 13, 2025Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT CHEMICALS DID NOT PASS THROUGH. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. THERE WERE NO PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010078 ↗
• MalfunctionApr 23, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT WHEN THE CLAMP WAS OPENED AND THE OPERATOR OF THE DEVICE TRIED TO FLOW THE CHEMICAL SOLUTION, THE SOLUTION DID NOT FLOW. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21890783 ↗
• MalfunctionMar 7, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED CHEMICALS IN THE DEVICE DID NOT PASS THROUGH. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. THERE WERE NO PATIENT HARM OR ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21543921 ↗
• MalfunctionMar 6, 2025Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT CHEMICALS DID NOT PASS THROUGH. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. THERE WERE NO PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21532940 ↗
• MalfunctionFeb 20, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT WHEN THE CLAMP WAS OPENED AND THE OPERATOR OF THE DEVICE TRIED TO FLOW THE CHEMICAL SOLUTION, THE SOLUTION DID NOT FLOW. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. THERE WERE NO PATIENT HARMS OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21428018 ↗
• MalfunctionFeb 13, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT WHEN REMOVING THE GRIPPER NEEDLE, INSTEAD OF LOCKING, THE NEEDLE SLIPPED FROM THE FRAME AND STRUCK THE INDEX FINGER OF THE DEVICE'S OPERATOR. THERE WERE UNKNOWN PATIENT HARM OR ADVERSE EVENT REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21379923 ↗
• MalfunctionFeb 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING REMOVAL OF THE NEEDLE PART OF THE DEVICE DETACHED. THE NEEDLE WAS REMOVED BY PULLING THE THREAD. THERE WAS A POTENTIAL BLOOD CONTAMINATION FOR THE STAFF. THERE WERE NO PATIENT HARM OR ADVERSE EVENTS REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21324272 ↗
• MalfunctionApr 15, 2021Fail-Safe Problem; Fail-Safe Problem

  IT WAS REPORTED THAT THE NEEDLE BROKE APART IN THE AREA WITHIN THE HINGE OF THE DELTEC GRIPPER PLUS. MORE SPECIFICALLY THIS WAS OBSERVED WHEN PULLING AND RELEASING THE SAFETY MECHANISM. THE PRODUCT PROBLEM DID NOT CAUSE OR CONTRIBUTE TO ANY ADVERSE HEALTH EFFECTS FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11672454 ↗
• MalfunctionApr 15, 2021Fail-Safe Problem; Fail-Safe Problem

  IT WAS REPORTED THAT THE NEEDLE BROKE APART IN THE AREA WITHIN THE HINGE OF THE DELTEC GRIPPER PLUS. MORE SPECIFICALLY THIS WAS OBSERVED WHEN PULLING AND RELEASING THE SAFETY MECHANISM. THE PRODUCT PROBLEM DID NOT CAUSE OR CONTRIBUTE TO ANY ADVERSE HEALTH EFFECTS FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11672302 ↗
• MalfunctionJan 14, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT DURING A BANDAGE CHANGE WITH THE PORT NEEDLE IN PLACE, THE OPERATOR NOTICED THAT THE PORT NEEDLE FELL APART WHEN THE BANDAGE FOIL WAS CAREFULLY PULLED OFF. THE NEEDLE PADDING AND THE SAFETY MECHANISM DETACHED FROM THE NEEDLE WITHOUT THE APPLICATION OF A STRONG PULLING FORCE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11172767 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021999. One submission often covers many models, so check the product and lot details in each record.

• Z-0253-2020 · Jul 15, 2019 · Terminated
  Port full Access Tray Product Code: DT19330