NA 00711812Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00724995180898), received between Jul 16, 2025 and Jun 10, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2026Retraction Problem

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR CARR-LOCKE INJECTION NEEDLE WOULD NOT RETRACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER INJECTOR NEEDLE FOLLOWING A SHORT DELAY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25460000 ↗
• MalfunctionApr 3, 2026Insufficient Device Problem Information

  THE USER FACILITY REPORTED VIA MEDWATCH#: (B)(4) THAT DURING A PATIENT PROCEDURE THEIR CARR-LOCKE INJECTION NEEDLE WAS SLOW TO OPEN. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24783379 ↗
• MalfunctionMar 5, 2026

  FROM STAFF: NEEDLE SLOW TO OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518645 ↗
• MalfunctionNov 25, 2025Break; Break

  THE USER FACILITY REPORTED VIA VIGILANCE REPORT THAT DURING A PATIENT PROCEDURE THE CONNECTOR TO THEIR CARR-LOCKE INJECTION NEEDLE WAS BROKEN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT NEEDLE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647302 ↗
• MalfunctionAug 15, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED VIA MEDWATCH (B)(4) THAT THEIR CARR-LOCKE INJECTION NEEDLE WAS LEAKING DURING A PATIENT PROCEDURE. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22818725 ↗
• MalfunctionJul 16, 2025Leak/Splash

  FROM STAFF: STERIS NEEDLE WAS LEAKING AT THE CONNECTOR WHILE IN USE FOR PROCEDURE. PATIENT CAME IN FOR ENDOSCOPY PROCEDURE, DURING PROCEDURE A STERIS NEEDLE WAS DEPLOYED FOR USE WITH A LIFTING AGENT. ONCE DEPLOYED THE NEEDLE WAS FOUND TO BE LEAKING AT THE CONNECTION SITE. NEEDLE WAS SEQUESTERED AND NEW NEEDLE WAS DEPLOYED, PROCEDURE WAS COMPLETED WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22519225 ↗

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