Echotip G16289Recalls & reported problems
Cook Incorporated · Echotip Disposable Amniocentesis Needle · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002162891), received between Dec 19, 2017 and Dec 19, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult To Position” (1 report).
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
Device problems
- Difficult To Position1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 2017Difficult To Position; Difficult To Position
THE USER FACILITY REPORTED DURING AN AMNIOCENTESIS PROCEDURE, THE COOK ECHO TIP AMNIOCENTESIS NEEDLE COULD NOT BE SEEN UNDER THE ULTRASOUND DURING THE PROCEDURE. ADDITIONAL INFORMATION THAT WAS RECEIVED WAS THE NEEDLE WAS MORE FLEXIBLE AND NOT VISIBLE. THERE WAS NO REPORT OF ANY ADVERSE EFFECTS OR CONSEQUENCES TO THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7132627 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.