CLEARVIEW® 31100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20885074257116), received between Feb 14, 2019 and Jun 7, 2024 — classified as 1 injury, 2 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 7, 2024Mechanical Problem; Unexpected Color; Mechanical Problem; Unexpected Color

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN ARTERIOTOMY SHUNT, IT WAS REPORTED THAT THE DEVICE IS TRANSPARENT AND CLEAR IN COLOUR THUS MAKING IT DIFFICULT TO SEE AGAINST THE HEART AND CORONARY ARTERIES DURING A CORONARY ARTERY BYPASS GRAFT SURGERY. THE TRANSPARENT COLOUR MAKES THEM DIFFICULT TO WORK WITH AND A HAZARD DUE THE INABILITY TO SEE THE SHUNT APPROPRIATELY WHEN SITUATED ON THE HEART AND IS COVERED WITH BLOOD. ACCORDING TO THE CUSTOMER THE SHUNT'S ARE NOT BEING DESIGNED AS THEY PREVIOUSLY WERE THUS MAKING THE THREAD ON THEM TOO LARGE AND BULKY FOR FINE DELICATE WORKING ON THE CORONARY ARTERIES DURING A CORONARY ARTERY BYPASS GRAFTING PROCEDURE. THEY ARE TEARING THE ARTERIES AND NOT FLEXIBLE ENOUGH TO WORK WITH. THE USE OF THE DEVICE WAS UNKNOWN. THERE WAS NO FURTHER ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19481720 ↗
• MalfunctionMar 13, 2024Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A ARTERIOTOMY SHUNT, THE CUSTOMER REPORTED THAT DURING CORONARY AORTIC BYPASS SURGERY WITH A BEATING HEART BEFORE THE INSERTION OF THE SHUNT INTO THE CORONARY ARTERIOTOMY, SIMPLY BY TOUCHING IT WITH THE APPROPRIATE FORCEPS, THE DEVICE BROKE INTO TWO PARTS AT THE INSERTION POINT OF THE SILK THREAD. 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 18892386 ↗
• MalfunctionFeb 14, 2019Fracture; Fracture

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THE CUSTOMER REPORTED THE 31100 ARTERIOTOMY SHUNT BROKE DURING REMOVAL FROM THE PATIENT'S CORONARY ARTERY. THE SHUNT WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8338517 ↗