NA 00711822Recalls & reported problems
US Endoscopy · The Carr-Locke injection needle is a single use, disposable, flexible sheath injection needle used for the injection of various types of media through flexible endoscopes. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00724995180928), received between Aug 13, 2026 and Aug 13, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Mechanical Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 13, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50230766 ↗
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 · TerminatedVari-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
Other Biopsy needle devices
- MAGNUM MN1410Bard Peripheral Vascular, Inc. · Biopsy needle1 recall118 reports
- Single Use Aspiration Needle NA-U401SX NA-U401SX-4021Olympus Medical Systems Corp. · Biopsy needle1 recall94 reports
- EchoTip G31520Cook Ireland Ltd · Biopsy needle1 recall84 reports
- Single Use Aspiration Needle NA-201SX-4021Olympus Medical Systems Corp. · Biopsy needle1 death126 reports
- EchoTip ProCore G34785Cook Ireland Ltd · Biopsy needle97 reports
- MAGNUM MN1820Bard Peripheral Vascular, Inc. · Biopsy needle1 recall37 reports
- Single Use Aspiration Needle NA-U401SX NA-U401SX-4022Olympus Medical Systems Corp. · Biopsy needle1 recall29 reports
- Interject M00518250Boston Scientific Corporation · Biopsy needle70 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.