NasoporeRecalls & reported problems across all models

We found 9 models of Nasopore by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 8 adverse event reports in the FDA's MAUDE database, received between Jun 20, 2018 and Aug 30, 2024 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (2 reports).

9 FDA recall records name at least one of these models by its device identifier, 9 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

Nasopore 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-1481-2025 · 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-1480-2025 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

3. 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-1479-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. 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-1478-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. 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-1476-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. 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-1474-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

7. 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-1473-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

8. 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-1471-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

9. 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-1470-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Nasopore problems

Nasopore models

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

• Nasopore 5400030008

  SPLINT, INTRANASAL SEPTAL
  2 recalls1 report
• Nasopore 5400010008

  SPLINT, INTRANASAL SEPTAL
  1 recall4 reports
• Nasopore 5400020108

  SPLINT, INTRANASAL SEPTAL
  1 recall3 reports
• Nasopore 5400010004

  SPLINT, INTRANASAL SEPTAL
  1 recall0 reports
• Nasopore 5400020004

  SPLINT, INTRANASAL SEPTAL
  1 recall0 reports
• Nasopore 5400020008

  SPLINT, INTRANASAL SEPTAL
  1 recall0 reports
• Nasopore 5400030004

  SPLINT, INTRANASAL SEPTAL
  1 recall0 reports
• Nasopore 5400212004s

  SPLINT, INTRANASAL SEPTAL
  1 recall0 reports
• Nasopore 5400222004S

  SPLINT, INTRANASAL SEPTAL
  1 recall0 reports

Recent Nasopore adverse event reports

The 8 most recent reports across all models, 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 ↗
• 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 18988857 ↗
• 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 18988856 ↗
• 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 18985579 ↗
• MalfunctionSep 12, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THERE WAS A POTENTIAL STERILITY BREACH ON THE PRODUCT PACKAGING DETECTED PRIOR TO USE. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15402395 ↗
• MalfunctionMay 15, 2019Material Disintegration; Material Disintegration

  IT WAS REPORTED THAT POST OPERATIVELY THAT THE NASOPORE PRODUCT DID NOT FRAGMENT AFTER THE PATIENT HAD IRRIGATED THE PRODUCT WITH SALINE SPRAY. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCE FOR THE PATIENT OR DELAYS TO SURGERY AS A RESULT OF THE REPORTED EVENT. IT WAS ALSO REPORTED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY.UPDATE; IT WAS SUBSEQUENTLY REPORTED THAT PATIENTS INFORMED THE SURGEON THEY ARE NOT CONSISTENTLY REMEMBERING TO USE THE SALINE SPRAY ¿A FEW¿ TIMES A DAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8611889 ↗
• InjuryJun 29, 2018Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT AFTER A SURGICAL PROCEDURE INVOLVING NASOPORE PRODUCT, THE PATIENT RETURNED TO THE HOSPITAL WITH ALLEGED TOXIC SHOCK SYNDROME IT WAS FURTHER REPORTED THAT THE PATIENT REQUIRED ADDITIONAL MEDICAL TREATMENT TO ADDRESS THE TOXIC SHOCK SYMPTOMS IT WAS ALSO REPORTED THAT THE PATIENT WAS TREATED SUCCESSFULLY.

  Patient problems: Toxic Shock Syndrome

  MAUDE report 7652324 ↗
• MalfunctionJun 20, 2018Packaging Problem; Packaging Problem

  IT WAS REPORTED DURING A SURGICAL PROCEDURE, THAT THERE WAS A POTENTIAL STERILITY BREACH ON THE PACKAGING. IT WAS ALSO REPORTED THAT THERE WAS NO DELAY AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7619035 ↗

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