CLEARVIEW® 31125Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20885074257406), received between Nov 9, 2023 and Oct 16, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 19, 2024Open, Classified

   Potential for unsealed sterile packing.

   Z-1803-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS ARTERIOTOMY SHUNT HAD THE BLUE TIP FALL OFF ALLEGEDLY WHILE IN THE PATIENT WAS IN OPERATING ROOM (OR). THE ORIGINAL INTENDED PROCEDURE WAS A CARDIOTHORACIC SURGERY. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20459915 ↗
• InjuryNov 9, 2023Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN ARTERIOTOMY SHUNT, IT WAS REPORTED THAT THE SHUNT CAME APART IN THE VESSEL. THE CUSTOMER HAD TO TAKE DOWN THE ANASTOMOSIS, EXTEND IT AND RE-DO IT AS A LONG PATCH ANGIOPLASTY IN ORDER TO GET THE PIECE OF THE SHUNT OUT OF THE VESSEL.  THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18100053 ↗