OptiSite Arterial Perfusion CannulaRecalls & reported problems across all models

We found 2 models of OptiSite Arterial Perfusion Cannula by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, received between Mar 4, 2022 and May 28, 2025 — classified as 1 injury, 4 malfunctions.

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

2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

OptiSite Arterial Perfusion Cannula recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · Recall details · FDA record ↗

2. 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 OptiSite Arterial Perfusion Cannula problems

OptiSite Arterial Perfusion Cannula models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• OptiSite Arterial Perfusion Cannula OPTI16

  CANNULA, CATHETER
  1 recall3 reports
• OptiSite Arterial Perfusion Cannula OPTI18

  CANNULA, CATHETER
  1 recall2 reports

Recent OptiSite Arterial Perfusion Cannula adverse event reports

The 5 most recent reports across all models, 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 ↗
• 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 ↗

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