Integra® 1650050Recalls & reported problems
Integra Lifesciences Production Corporation · Integra® Oro-Tracheal Injection Needle · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780075097), received between Dec 29, 2021 and Jul 29, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (2 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Entrapment of Device1
- Fracture1
- Migration1
- Separation Problem1
Patient problems
- Foreign Body In Patient2
- No Clinical Signs, Symptoms or Conditions2
- Cough1
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 29, 2025Break; Break
THE FOLLOWING WAS REPORTED VIA MEDWATCH/MDR REPORT# MW5172110: A FACILITY REPORTED THAT DURING AN "ORO-TRACHEAL" PROCEDURE, THE NEEDLE 1650050 5PK ORO-TRACHEAL INJECTOR (1650050) BROKE WHILE BEING USED TO INJECT KENALOG TO THE PATIENT'S SUBGLOTTIC AREA. THE SURGERY WAS PAUSED, AND THE NEEDLE WAS RETRIEVED FROM THE SUBGLOTTIC TISSUE IN ITS ENTIRETY. A NEW ORO-TRACHEA NEEDLE WAS OPENED TO COMPARE SIZES AND TO ENSURE THAT THE ENTIRE BROKEN NEEDLE WAS RETRIEVED FROM THE PATIENT. PICTURES WERE TAKEN AS PROOF OF RETRIEVAL AND AS A COMPARISON TO THE WHOLE, UNBROKEN NEEDLE. THERE WAS NO INJURY, DEATH, OR SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22642300 ↗InjuryNov 9, 2023Separation Problem; Separation Problem
InjuryDec 29, 2021Break; Entrapment of Device; Fracture; Migration; Break; Entrapment of Device; Fracture; Migration
N/A.
Patient problems: Cough; Foreign Body In Patient; Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13110239 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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