PneumoDart TM-317Recalls & reported problems
TyTek Medical Inc. · Superior Tension Pneumothorax Decompression Needle · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00855204008167), received between Oct 6, 2023 and Oct 6, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
1 FDA recall record name this device's identifier.
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
Recalls naming this device
- Oct 5, 2020Terminated
Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
Z-2612-2023 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
COMPLAINT FOLLOWING AN INCIDENT WITH AN AMBULANCE SERVICE: CASE: PATIENT AT HOME, MALE, YEAR OF BIRTH 1939, SEVERE DIFFICULTY BREATHING, 112 REPORT, AMBULANCE ARRIVES ON SITE, TREATMENT STARTS. CREW INDICATES, ON THE BASIS OF SYMPTOMS AND EXAMINATIONS, THE APPLICATION OF A PNEUMO-DART NEEDLE TO RELIEVE A TENSION PNEUMOTHORAX> PARTIAL IMPROVEMENT. TRANSPORT TO HOSPITAL, SITUATION DEGENERATES INTO RESUSCITATION. LATER CT SCAN SHOWS THAT THE PNEUMO-DART NEEDLE IS (TOO) DEEP, AND HAS CAUSED DAMAGE / BLEEDING. PATIENT THEN STAYS FOR DAYS IN IC OF HOSPITAL. THE INTENSIVIST THEN CONTACTS THE DOCTOR OF THE AMBULANCE SERVICE. THE RESPONSIBLE COMMITTEE OF AMBULANCE SERVICE DISCUSSED THIS CASE ON (B)(6) 2019, AFTER THE CREW CONCERNED HAS GIVEN WRITTEN REFLECTION AND TELEPHONE EXPLANATION OF THE INCIDENT. CONCLUSIONS OF THE COMMITTEE REGARDING THE CASE: INDICATION OF THE PLACEMENT OF THE PNEUMODART® NEEDLE IS WELL ARGUED AND THEREFORE SUFFICIENT. RETROSPECTIVELY THERE IS DOUBT AS TO WHETHER THERE HAS ACTUALLY BEEN A PNEUMOTHORAX BEFORE THE NEEDLE WAS PLACED, HOWEVER IN THE AMBULANCE SETTING THERE IS NO WAY TO GET COMPLETE CERTAINTY ABOUT THIS. AS MENTIONED, THERE HAVE BEEN ENOUGH GOOD ARGUMENT
Patient problems: Insufficient Information
MAUDE report 17886283 ↗
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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 · each recall links to the FDA recall notice
- 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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