AcuJectRecalls & reported problems across all models

We found 2 models of AcuJect by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 6 adverse event reports in the FDA's MAUDE database, received between Mar 6, 2025 and Sep 11, 2026 — classified as 1 injury, 5 malfunctions.

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

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

AcuJect recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 14, 2019Terminated

   Potential for occluded injection needles.

   Z-2089-2019 · Root cause: Employee error · Recall details · FDA record ↗

Most reported AcuJect problems

AcuJect models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• AcuJect G22526

  endoscopic injection needle, gastroenterology-urology
  1 recall1 report
• AcuJect G22525

  endoscopic injection needle, gastroenterology-urology
  5 reports

Recent AcuJect adverse event reports

The 6 most recent reports across all models, 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 ↗
• MalfunctionMay 27, 2026Detachment of Device or Device Component

  IN PREPARATION FOR A PROCEDURE, THE PHYSICIAN SELECTED TWO A COOK ACUJECT VARIABLE INJECTION NEEDLES. IT WAS INITIALLY REPORTED THAT BEFORE USE [THE PHYSICIAN] REMOVED THE INJECTION NEEDLE FROM THE PACKAGING BOX ACCORDING TO THE GUIDANCE AND TESTED WHETHER THE NEEDLE COULD BE RETRACTED AND EXTENDED NORMALLY. IT WAS FOUND THAT THE NEEDLE CORE COULD NOT BE FLEXIBLY ADVANCED AND RETRACTED ACCORDING TO THE HANDLE OPERATION. ANOTHER OF THE SAME DEVICE WAS USED FOR CONTINUED TREATMENT. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. OUR EVALUATION OF THE RETURNED DEVICE ON 01 MAY 2026 DETERMINED THAT THE HANDLE IS DETACHED FROM THE INNER CATHETER [UNABLE TO INJECT - SUBJECT OF REPORT]. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE USER SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25300608 ↗
• 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 ↗

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