NA 00711811 (UDI 00724995180881)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00724995180881), received between Aug 6, 2020 and Jul 16, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K232826, K971842); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25845328 ↗
• MalfunctionMay 27, 2026Ejection Problem

  THE USER FACILITY REPORTED VIA MEDWATCH THAT THEIR CARR-LOCKE INJECTION NEEDLE WOULD NOT PRIME BEFORE GOING INTO THE SCOPE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25302700 ↗
• MalfunctionMay 14, 2026Device Difficult to Setup or Prepare

  THE USER FACILITY REPORTED VIA MEDWATCH MW5185323, "OPENED A CARLOCK NEEDLE TO INJECT EPI DURING A PROCEDURE AND THE NEEDLE AS DEFECTIVE, THE EPI WOULD NOT GO THROUGH THE NEEDLE. GOT A NEW ONE AND IT WORKED FINE." NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25174017 ↗
• MalfunctionMar 28, 2025Retraction Problem; Retraction Problem

  THE USER FACILITY REPORTED THAT DURING PATIENT PROCEDURES THEIR CARR-LOCKE INJECTION NEEDLES WOULD NOT RETRACT. THE PROCEDURES WERE COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21724209 ↗
• MalfunctionMar 8, 2025Mechanical Problem; Mechanical Problem

  THE USER FACILITY REPORTED VIA MEDWATCH REPORT (B)(4). "THIS WAS A FAILURE OF EQUIPMENT, SPECIFICALLY THE CARR-LOCKE INJECTION NEEDLE 25 GA STERIS BRAND. WHEN INSTRUCTED TO BRING NEEDLE OUT, NEEDLE WAS PUSHED OUT AND WORKED PROPERLY, BUT WHEN NEEDLE WAS ATTEMPTED TO BE BROUGHT BACK IN, THE NEEDLE STAYED OUT DESPITE LUER-LOCK DEVICE BEING FULLY DISCONNECTED." THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER INJECTOR NEEDLE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21555119 ↗
• MalfunctionJul 11, 2024Retraction Problem; Retraction Problem

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR CARR-LOCKE INJECTION NEEDLE WAS DEPLOYED SUCCESSFULLY HOWEVER, THE NEEDLE WOULD NOT RETRACT AFTER LIFTING THE POLYP. USER FACILITY PERSONNEL UTILIZED ANOTHER CARR-LOCKE INJECTION NEEDLE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19719569 ↗
• MalfunctionFeb 15, 2024Break; Break

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE LUER LOCK CONNECTION ON THEIR CARR LOCKE INJECTION NEEDLE BROKE OFF SUBSEQUENTLY CAUSING INJECTION MEDIA TO CONTACT AN EMPLOYEE. USER FACILITY PERSONNEL UTILIZED ANOTHER CARR LOCKE INJECTION NEEDLE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18715008 ↗
• MalfunctionOct 20, 2022Loss of or Failure to Bond; Insufficient Device Problem Information; Loss of or Failure to Bond; Insufficient Device Problem Information

  THE USER FACILITY REPORTED VIA MEDWATCH REPORT (B)(4) THAT DURING A PATIENT PROCEDURE, THE HANDLE TO THEIR CARR-LOCKE INJECTION NEEDLE DEVICE CAME APART AND WAS NOT OPERATING PROPERLY. NO REPORT OF INJURY.

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

  MAUDE report 15640442 ↗
• MalfunctionSep 2, 2022Failure to Form Staple

  RESOLUTION CLIP - WHILE TECH TRIED TO CLAMP DOWN WITH RESOLUTION CLIP IT WOULD NOT CLOSE APPROPRIATELY AND PULLED TO THE SIDE. SCLEROTHERAPY NEEDLE, WHILE TRYING TO PUSH THE NEEDLE OUT THE HARDWARE OF THE HANDLE PULLED AWAY. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 15362815 ↗
• MalfunctionJan 14, 2022Retraction Problem; Insufficient Device Problem Information; Retraction Problem; Insufficient Device Problem Information

  THE USER FACILITY REPORTED VIA HEALTH (B)(6) REPORT TO STERIS THAT THEIR CARR-LOCKE INJECTION NEEDLE FAILED TO RETRACT. THERE WAS NO REPORT OF HARM TO THE PATIENT OR USER OF THE DEVICE.

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

  MAUDE report 13258267 ↗
• MalfunctionAug 6, 2020Difficult to Open or Close

  THROUGH REVIEW OF THE MAUDE DATABASE, STERIS ENDOSCOPY DISCOVERED USER FACILITY MEDWATCH REPORT NUMBER MW5095362, WHICH REPORTED THAT A CARR-LOCKE INJECTION NEEDLE WOULD NOT OPEN / FAILED TO FUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 10376295 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K232826, K971842. One submission often covers many models, so check the product and lot details in each record.

• Z-0289-2017 · May 18, 2016 · Terminated
  Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible sheath device intended to be used for the injection of various types o