Aliya Needle GTI-00023Recalls & reported problems
Galvanize Therapeutics, Inc. · Aliya Needle, 5 pack · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850031859005), received between Sep 10, 2026 and Sep 18, 2026 — classified as 3 injuries.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Pneumothorax3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Pneumothorax
MAUDE report 50830984 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Pneumothorax
MAUDE report 50826768 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Pneumothorax
MAUDE report 50723737 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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