ThruPort Systems EndoReturn Arterial Cannula Kit ER21BRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103191400), received between Mar 18, 2025 and Mar 18, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K971291); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2025Mechanical Problem; Mechanical Problem

  EDWARDS RECEIVED A REPORT OF AN ER21B ISSUE DURING AN RMVR PROCEDURE WHERE THE ICF100 COULD NOT PASS THROUGH. THERE WAS NO ABNORMALITY DETECTED PRIOR TO USE OR AFTER THE EVENT. THE ER21B WAS INSERTED INTO THE FEMORAL ARTERY WITHOUT PROBLEM AND ARTERIAL LINE TEST WAS DONE SUCCESSFULLY. ICF WAS CORRECTLY PREPPED PREOP BUT WOULD NOT PASS THROUGH THE END OF THE ER21B END. IT WAS NOT THE RHV PER CLINICAL FEEDBACK; THE WIRE WAS ABLE TO GO THROUGH BUT NOT THE ICF100. THE ICF WAS DE-AIRED AGAIN WITH NEGATIVE SUCTION AND RETRIED. THE ER21B WAS ADJUSTED A BIT MORE LATERALLY AND SECURED. AGAIN, THE ICF WAS ATTEMPTED MULTIPLE TIMES BUT UNABLE TO PASS THROUGH THE END OF THE ER21B. THE ER21B WAS REMOVED SUCCESSFULLY AND NEW ER21B WAS INSERTED (FROM THE SAME LOT). THE SAME ICF WAS INSERTED INTO THE ER21B AND SUCCESSFULLY PASSED THROUGH THE END OF THE ER21B. PROCEDURE WAS DONE SUCCESSFULLY. PATIENT STATUS REPORTED AS FINE, BUT THERE WAS MINOR BLOOD LOSS DURING CANNULA EXCHANGE. NEITHER THE DEVICE NOR THE ICF100 THAT WAS USED IS AVAILABLE FOR RETURN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21638161 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K971291. One submission often covers many models, so check the product and lot details in each record.

• Z-1972-2013 · Jul 16, 2013 · Terminated
  Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: The ThruPort EndoReturn arterial cannula kit (with or without hemostasis valve), an introducer, a guidewi
• Z-0307-04 · Oct 2, 2003 · Terminated
  EndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The EndoReturn cannula with hemostasis valve allows for
• Z-0308-04 · Oct 2, 2003 · Terminated
  EndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The EndoReturn cannula with hemostasis valve allows for
• Z-0309-04 · Oct 2, 2003 · Terminated
  DirectFlow arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The product also allows the hemostatic introduction and removal of t
• Z-0311-04 · Oct 2, 2003 · Terminated
  Introducer Sheath is indicated for patients requiring introduction of catheters. Introducer Sheath for EndoClamp, aortic catheter, 19Fr. IS19 (07042).
• Z-0310-04 · Oct 2, 2003 · Terminated
  SoftClamp II arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The product also allows the hemostatic introduction and removal of