Hemopore 5400020208Recalls & reported problems
Stryker Corporation · Class 1 · Implant
All models of Hemopore (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327117233), received between Apr 14, 2023 and Mar 27, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Material Too Rigid or Stiff” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
- Feb 25, 2025Open, Classified
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
Z-1477-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Material Too Rigid or Stiff2
Patient problems
- Inflammation2
- Wound Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED POST OPERATIVELY THAT A SURGEON STATED THAT THE PRODUCT CAUSED INFECTION. IT WAS ALSO REPORTED THERE WERE NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Wound Infection
MAUDE report 18988859 ↗InjuryApr 14, 2023Material Too Rigid or Stiff; Adverse Event Without Identified Device or Use Problem; Material Too Rigid or Stiff; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ONE WEEK POST FUNCTIONAL ENDOSCOPIC SINUS SURGICAL PROCEDURE, TWO PATIENTS PRESENTED WITH AN INFLAMMATORY RESPONSE. THIS REPORT ADDRESSES ONE OF THE PATIENTS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Inflammation
MAUDE report 16745035 ↗InjuryApr 14, 2023Material Too Rigid or Stiff; Adverse Event Without Identified Device or Use Problem; Material Too Rigid or Stiff; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ONE WEEK POST FUNCTIONAL ENDOSCOPIC SINUS SURGICAL PROCEDURE, TWO PATIENTS PRESENTED WITH AN INFLAMMATORY RESPONSE. THIS REPORT ADDRESSES ONE OF THE PATIENTS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Inflammation
MAUDE report 16744828 ↗
Other SPLINT, INTRANASAL SEPTAL devices
- Nasopore 5400030008Stryker Corporation · SPLINT, INTRANASAL SEPTAL2 recalls1 report
- Nasopore 5400010008Stryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall4 reports
- Nasopore 5400020108Stryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall3 reports
- Nasopore 5400222004SStryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall0 reports
- Nasopore 5400010004Stryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall0 reports
- Nasopore 5400020004Stryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall0 reports
- Nasopore 5400030004Stryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall0 reports
- Nasopore 5400212004sStryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall0 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 · 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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