HemoporeRecalls & reported problems across all models

We found 2 models of Hemopore by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, 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).

2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Hemopore recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. 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-1482-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. 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 Hemopore problems

Hemopore models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Hemopore 5400020208

  SPLINT, INTRANASAL SEPTAL
  1 recall3 reports
• Hemopore 5400222208S

  SPLINT, INTRANASAL SEPTAL
  1 recall0 reports

Recent Hemopore adverse event reports

The 3 most recent reports across all models, 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 Stryker Corporation products

• RemB7 models · 3,073 reports
• Prime Series21 models · 1,548 reports · 2 recalls
• TARGET114 models · 1,077 reports
• ProCuity17 models · 368 reports · 13 recalls
• Spetzler-Malis20 models · 7 reports · 19 recalls
• SYNCHRO 28 models · 313 reports · 9 recalls
• Neptune E-SEP19 models · 412 reports · 7 recalls
• StrykeFlow4 models · 552 reports · 4 recalls