OptiSite Arterial Perfusion Cannula OPTI18Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00690103180565), received between Mar 4, 2022 and Nov 23, 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.

2 other recalls cover devices cleared under the same FDA submission (K073559); they may or may not involve this specific model.

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. May 14, 2025Open, Classified

   due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.

   Z-2081-2025 · Root cause: Under Investigation by firm · 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.

• MalfunctionNov 23, 2024Break; Break

  PER THE REPORT RECEIVED FROM GERMANY AN OPTI18 CANNULA WAS FOUND TO HAVE THE WIRE OUTSIDE FROM THE CANNULA. AS REPORTED IT WAS NOTICED, WHEN THE CANNULA WAS ABOUT TO BE INSERTED INTO THE ARTERY. THERE WAS NO INJURY FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20766834 ↗
• InjuryMar 4, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT AN ARTERIAL CANNULA GOT KINKED DURING PROCEDURE. ANOTHER CANNULA WAS USED. THERE WAS NO PATIENT INJURY. AS REPORTED, NOTHING UNUSUAL HAPPENED DURING CANNULATION PROCESS. THE CANNULA WAS SECURED, WHICH PUTS IT AT SOMEWHAT OF A BEND. THE SURGICAL TEAM WENT ON BYPASS AND NOTICED HIGH LINE PRESSURES. CANNULA WAS CHECKED AND KINKING WAS OBSERVED WHERE THE MAIN CANNULA TUBING MEETS THE THICKER TUBING. THE SURGEON WAS NOT ABLE TO PINCH CANNULA TO RELIEVE THE KINKING. A NEW DEVICE HAD TO BE USED. IT WAS BELIEVED THAT FOR SOME REASON, THE CANNULA IS NOT AS ROBUST AT THAT POINT AS IT USED TO BE, AND IT IS KINKED WHEN IT IS SECURED IN A CURVED FASHION. THE SURGEON IS EXTREMELY SKILLED AND HAS BEEN DOING SURGERY FOR 25 YEARS. HIS TECHNIQUE IS IDENTICAL EVERY TIME. HE HAS USED THIS SAME CANNULA FOR AT LEAST 7 YEARS WITH NO ISSUES BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13668726 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K073559. One submission often covers many models, so check the product and lot details in each record.

• Z-2080-2025 · May 14, 2025 · Open, Classified
  Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. The Edwards O
• Z-3034-2018 · Mar 7, 2018 · Terminated
  Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized.