Nasopore 5400030008Recalls & reported problems
Stryker Corporation · Extra Firm 8cm · Class 1 · Implant
All models of Nasopore (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613154340842), received between Aug 30, 2024 and Aug 30, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (1 report).
2 FDA recall records name this device's identifier, 2 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 18, 2026.
Reports received per month
Recalls naming this device
- Feb 25, 2025Class IIOpen, 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-1479-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Feb 25, 2025Class IIOpen, 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-1481-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Tear, Rip or Hole in Device Packaging1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 30, 2024Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging
UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT THIS EVENT IS NOT REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20108157 ↗
Other SPLINT, INTRANASAL SEPTAL devices
- Nasopore 5400010008Stryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall4 reports
- Nasopore 5400020108Stryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall3 reports
- Hemopore 5400020208Stryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall3 reports
- Nasopore 5400212004sStryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall0 reports
- Nasopore 5400030004Stryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall0 reports
- Hemopore 5400222208SStryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall0 reports
- Nasopore 5400222004SStryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall0 reports
- Nasopore 5400010004Stryker 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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