Deflux Metal Needle 3.7 FR x 23 G (tip) x 350 mmRecalls & reported problems
Palette Life Sciences, Inc. · Deflux metal needle · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00850004725023), received between Feb 18, 2026 and Feb 18, 2026 — classified as 1 injury.
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 Problem1
Patient problems
- Urinary Tract Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT "THE RESEARCH SUBJECT DEVELOPED A URINARY TRACT INFECTION AFTER PROTOCOL TREATMENT (DEFLUX INJECTION THERAPY) PERFORMED ON (B)(6) 2025, AND THE HOSPITAL STAY WAS EXTENDED FOR FURTHER TREATMENT. THE RESEARCH SUBJECT PERFORMED PROTOCOL TREATMENT ON (B)(6) 2025, AND IT WAS COMPLETED WITHOUT ANY PROBLEMS, BUT THE FOLLOWING DAY, MARCH 20, 2025, THE SUBJECT DEVELOPED A FEVER OF OVER 38 C, POSITIVE URINARY WHITE BLOOD CELLS, AND HIGH INFLAMMATORY RESPONSE. BASED ON THE EXAMINATION AND GENERAL CONDITION, FEVER DUE TO INFECTION AND POSTOPERATIVE REACTION WAS SUSPECTED. BEFORE INJECTING DEFLUX TRANSURETHRALLY, SALINE IS INJECTED RETROGRADELY DURING TRANSURETHRAL SURGERY TO ENSURE A CLEAR VIEW. HOWEVER, IT WAS DETERMINED THAT THE POSSIBILITY OF INCREASED INTRAVESICAL PRESSURE, URETERAL REFLUX, AND A URINARY TRACT INFECTION DUE TO RETROGRADE INFECTION COULD NOT BE RULED OUT. BECAUSE A CAUSAL RELATIONSHIP TO THE PROTOCOL TREATMENT PROCEDURE CANNOT BE RULED OUT, THIS EVENT WILL BE REPORTED AS A SERIOUS ILLNESS. THE PATIENT'S FEVER QUICKLY SUBSIDED WITH INTRAVENOUS ANTIBIOTICS AND ORAL NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NDAIDS), AND THE INFLAMMATORY FINDINGS ALSO IMPROVED,
Patient problems: Urinary Tract Infection
MAUDE report 24381568 ↗
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- Bulkamid 50050Contura International A/S · Agent, Bulking, Injectable For Gastro-Urology Use9 reports
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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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