OptiSite Arterial Perfusion Cannula OPTI16Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00690103180558), received between Jan 6, 2025 and May 28, 2025 — classified as 3 malfunctions.

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

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-2080-2025 · Root cause: Under Investigation by firm · Recall details · 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.

• MalfunctionMay 28, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT DEFORMATION OF THE WIRE OF AN OPTI16 ARTERIAL PERFUSION CANNULA WAS OBSERVED AT THE PROXIMAL END BEFORE USE. THE ISSUE WAS FOUND JUST BEFORE INSERTING THE CANNULA INTO THE PATIENT AFTER OPENING THE POUCH. THE DEVICE WAS EXCHANGED WITH ANOTHER OPTI16 CANNULA AND WAS NEVER USED ON THE PATIENT. NO PATIENT ADVERSE EVENT WAS REPORTED. PER THE REPORTED INFORMATION, THIS EVENT OCCURRED IN A PEDIATRIC CARDIOVASCULAR SURGERY CASE. THERE WERE NO DAMAGES OBSERVED ON THE SHELF BOX OR THE OUTER BOX. THE POUCH WAS COMPLETELY SEALED BEFORE OPENING. THE DEVICE WAS STORED HORIZONTALLY ON THE SHELF IN THE HOSPITAL STORAGE WITH THE ROOM TEMPERATURE KEPT AROUND 20 DEGREES CELSIUS. THE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS RETURNED WITH A TUBE ATTACHING NEAR THE WIRE DEFORMATION SITE AS A MARKER. A PHOTO OF THE WIRE DEFORMATION WAS TAKEN BY THE SALES REP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22101658 ↗
• MalfunctionMar 24, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  EDWARDS RECEIVED A REPORT STATING THEY HAD THE WIRE POKE THROUGH THE PLASTIC YESTERDAY DURING A CASE IN REFERRING TO AN OPTI16 CANNULA. NOTHING WAS OBSERVED BY THE SCRUB NURSE WHEN RECEIVING THE CATHETER. THE EVENT OCCURRED DURING INSERTION JUST PRIOR TO ENTERING THE VESSEL (NO DEPTH WITHIN THE AORTA), AND THEN THEY REPLACED IT WITH ANOTHER OPTI16 FROM THE SAME LOT NUMBER. NO PATIENT ISSUES REPORTED. THE PACKAGE HAD NO VISIBLE DAMAGE. A CUSTOMER LETTER IS REQUESTED, AND THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED CONCERNING STORAGE CONDITIONS: OR TEMPERATURE RANGE 65-75; HUMIDITY LEVEL BETWEEN 20-60%; EXACT VALUES ON DAY OF EVENT ARE ASSUMED TO BE WITHIN THE NORMAL RANGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21684148 ↗
• MalfunctionJan 6, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE WIRE AT THE TIP OF AN OPTI16 (16FR OPTISITE ARTERIAL CANNULAS) CANNULA, LOT BSLC7513, WAS STICKING STRAIGHT OUT FROM THE CANNULA; HOWEVER, THE EXPOSED WIRE DID NOT PUNCTURE THE PACKAGING. THE CANNULA WAS NOT USED IN THE PROCEDURE AS THE SURGEON NOTICED THE EXPOSED WIRE BEFORE IT WAS PUT IN THE PATIENT. THE INCIDENT WAS REPORTED BY THE PERFUSION TEAM. THERE WAS NO CHANGE IN PROCEDURAL STRATEGY DUE TO THE REPORTED INCIDENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. PICTURES OF THE CANNULA WERE PROVIDED AND THE CANNULA IS AVAILABLE FOR RETURN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21087043 ↗

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-2081-2025 · May 14, 2025 · Open, Classified
  Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 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.