Nasopore 5400010008Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613154340804), received between Jun 20, 2018 and Sep 12, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Disintegration” (1 report).

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.

Recalls naming this device

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

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗