AcuJect G22525Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002225251), received between Mar 6, 2025 and Sep 11, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Break; Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50738496 ↗
• MalfunctionJun 11, 2026Blocked Connection

  DURING AN ENDOSCOPIC INJECTION, THE PHYSICIAN USED A COOK ACUJECT VARIABLE INJECTION NEEDLE. IT WAS REPORTED THAT BEFORE USING THE SCLEROTHERAPY NEEDLE, [THE PHYSICIAN] PERFORMED THE LAVAGE AND FOUND THAT IT WAS OBSTRUCTED BECAUSE NO SALINE SOLUTION WAS COMING OUT. THE COMPANY REPRESENTATIVE STATED THAT HE HELD THE NEEDLE IN HIS HAND AND SAW NO SIGN OF IT BEING BENT OR MARKED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY FURTHER ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25466184 ↗
• MalfunctionJan 9, 2026Break; Positioning Failure

  IN PREPARATION FOR A PROCEDURE, THE PHYSICIAN SELECTED TWO (2) COOK ACUJECT VARIABLE INJECTION NEEDLES. IT WAS REPORTED THAT THE PHYSICIAN OPENED THE TWO (2) PACKAGES AND FOUND BOTH DEVICES WITH END BROKEN [HANDLE BROKEN - UNABLE TO INJECT], USER CHANGED TO ANOTHER NEW DEVICE TO CONTINUE THE PROCEDURE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24028684 ↗
• MalfunctionNov 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING AN ENDOSCOPIC INJECTION, THE PHYSICIAN USED A COOK ADJECT VARIABLE INJECTION NEEDLE. WHEN USING THE SCLEROSIS NEEDLE, THE USER NOTICED GREAT DIFFICULTY IN TESTING ITS EXPOSURE [ADVANCEMENT]. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, THERE WAS ONE WITH EXPOSURE BEYOND NORMAL. WHEN RETRACTING THE TIP, THE MANDREL CAME LOOSE FROM THE CATHETER LUMEN, MAKING IT IMPOSSIBLE TO USE [UNABLE TO INJECT]. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY FURTHER ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597818 ↗
• InjuryMar 6, 2025Break; Positioning Failure; Break; Positioning Failure

  DURING A PANENDOSCOPY PROCEDURE DUE TO HEMORRHAGE IN DIGESTIVE TRACT, THE PHYSICIAN USED TWO COOK ACUJECT VARIABLE INJECTION NEEDLES. IT WAS REPORTED THAT DURING THE PROCEDURE, THE TECHNICIAN REPORTED AT THE MOMENT OF SCLEROSING THE VARICOSE VEIN BY INJECTION, THE INJECTION HEAD BROKE. IT WAS IMMEDIATELY REMOVED, AND ANOTHER VIN-25 MEDICAL DEVICE WAS INSERTED, WHICH BREAKS AGAIN. BLEEDING WAS STOPPED WITH THE USE OF A THERMOSPRAY. IMAGES OF THE DEVICES WITH THE HANDLE BROKEN WERE PROVIDED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PRE-EXISTING BLEEDING INTENDED TO BE TREATED BY THE INJECTION NEEDLES WAS STOPPED WITH THE USE OF THERMOSPRAY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 21537407 ↗