RUSCH IPN042923Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 14026704336170), received between May 20, 2021 and Jan 29, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Discolored” (3 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2025Material Discolored; Material Discolored

  IT WAS REPORTED THAT: "THE ITEM ITSELF IS CHANGING COLOR. IT SHOULD BE GREEN BUT SOME ITEMS HAVE TURNED COMPLETELY BLACK, WHILE OTHERS YOU CAN SEE THEM CHANGING FROM GREEN TO BLACK. THE PACKAGING IS FALLING APART. NONE OF THESE PRODUCTS HAVE EXPIRED YET, BUT THE PACKAGING IS RIPPING OPEN AND FALLING APART". ASSOCIATED COMPLAINTS: 8040412-2025-00002, 8040412-2025-00003, 8040412-2025-00004 AND 8040412-2025-00005.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21263367 ↗
• MalfunctionJan 29, 2025Material Discolored; Material Discolored

  IT WAS REPORTED THAT: "THE ITEM ITSELF IS CHANGING COLOR. IT SHOULD BE GREEN BUT SOME ITEMS HAVE TURNED COMPLETELY BLACK, WHILE OTHERS YOU CAN SEE THEM CHANGING FROM GREEN TO BLACK." THE ISSUE WAS IDENTIFIED PRIOR TO USE. ASSCOCIATED COMPLAINTS 8040412-2025-00002, 8040412-2025-00003, AND 8040412-2025-00018.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21262680 ↗
• MalfunctionJan 3, 2025Material Discolored; Material Discolored

  IT WAS REPORTED THAT: "THE ITEM ITSELF IS CHANGING COLOR. IT SHOULD BE GREEN BUT SOME ITEMS HAVE TURNED COMPLETELY BLACK, WHILE OTHERS YOU CAN SEE THEM CHANGING FROM GREEN TO BLACK. THE PACKAGING IS FALLING APART. NONE OF THESE PRODUCTS HAVE EXPIRED YET, BUT THE PACKAGING IS RIPPING OPEN AND FALLING APART". ASSOCIATED COMPLAINTS 8040412-2025-00003, 8040412-2025-00004 AND 8040412-2025-00005.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21065939 ↗
• MalfunctionJan 3, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT: "THE ITEM ITSELF IS CHANGING COLOR. IT SHOULD BE GREEN BUT SOME ITEMS HAVE TURNED COMPLETELY BLACK, WHILE OTHERS YOU CAN SEE THEM CHANGING FROM GREEN TO BLACK. THE PACKAGING IS FALLING APART. NONE OF THESE PRODUCTS HAVE EXPIRED YET, BUT THE PACKAGING IS RIPPING OPEN AND FALLING APART". ASSOCIATED COMPLAINTS 8040412-2025-00002 AND .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21065848 ↗
• MalfunctionMay 20, 2021Moisture or Humidity Problem; Moisture or Humidity Problem

  IT WAS REPORTED "I SPOKE WITH A STAFF MEMBER WHO DESCRIBED ONE OF THE 18542032 UNITS AS HAVING CONDENSATION WITHIN THE PACKAGING". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11858651 ↗