PuraSinus 3mL 651-008Recalls & reported problems
3-D Matrix Inc. · PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (3 mL) · Class 2 · Implant
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 00860001820836), received between Jul 26, 2022 and Jul 26, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
1 other recall cover devices cleared under the same FDA submission (K183015); they may or may not involve this specific model.
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.
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
Patient problems
- Impaired Healing1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 26, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
A DOCTOR REPORTED A PATIENT INVOLVED IN A SURGICAL PROCEDURE WITH PURASINUS REQUIRED HOSPITALIZATION DUE TO A RE-BLEED.
Patient problems: Impaired Healing
MAUDE report 15102080 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K183015. One submission often covers many models, so check the product and lot details in each record.
- Z-0744-2022 · Dec 2, 2019 · TerminatedPuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006
Other Polymer, Ear, Nose And Throat, Synthetic, Absorbable devices
- Otopore 5400020100Stryker Corporation · POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE1 recall0 reports
- PuraSinus 5mL 651-0093-D Matrix Inc. · Polymer, Ear, Nose And Throat, Synthetic, Absorbable1 recall0 reports
- Otopore 5400020000Stryker Corporation · POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE1 recall0 reports
- Otopore 5400010000Stryker Corporation · POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE1 recall0 reports
- LATERA LATANI02Stryker Corporation · Polymer, Ear, Nose And Throat, Synthetic, Absorbable12 reports
- LATERA LATSYS24Stryker Corporation · Polymer, Ear, Nose And Throat, Synthetic, Absorbable8 reports
- 1.5 LACTOSORB SYSTEM 915-2315Biomet Microfixation, Inc · POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE3 reports
- LATERA LATSYS20Stryker Corporation · Polymer, Ear, Nose And Throat, Synthetic, Absorbable3 reports
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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