Select Series® 72120Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20643169485932), received between Feb 9, 2022 and Feb 9, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 (K840002); 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. Mar 19, 2024Open, Classified

   Potential for unsealed sterile packing.

   Z-1793-2024 · Root cause: Process control · FDA record ↗

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.

• MalfunctionFeb 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A SELECT SERIES STRAIGHT TIP ARTERIAL CANNULA, THE CUSTOMER REPORTED THAT DURING THE INSTALLATION OF THE EXTRACORPOREAL CIRCULATION THE MEDICAL TEAM NOTICED A LEAK ON THE UPPER PART OF THE CANNULA. THE PLUG THAT ALLOWS THE CANNULA TO BE CLOSED WHILE WAITING FOR THE CONNECTION TO THE THE EXTRACORPOREAL CIRCULATION MACHINE WAS NOTED TO NOT BE WATERTIGHT; WITH THE PRESSURE, THE PATIENT'S BLOOD LEAKED OUT AT THIS LEVEL. TO PREVENT THIS, THE CANNULA WAS CLAMPED WHILE WAITING FOR THE CONNECTION TO THE MACHINE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION: THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THE DAMAGE WAS NOT IN THE LOCATION OF THE SUTURES. THERE WAS 40-50 ML OF PATIENT BLOOD LOSS AS A RESULT OF THIS LEAK. NO TRANSFUSION WAS REQUIRED AS A RESULT OF THIS LEAK IT WAS CLARIFIED THAT ¿THIS EXPOSED THE CAREERS TO AN AES¿ MEANT THAT "THE CAREERS WEREN'T REALLY EXPOSED TO BLOOD. THE FLOW OF BLOOD WAS JUST FLOWING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13498028 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K840002. One submission often covers many models, so check the product and lot details in each record.

• Z-0986-2025 · Dec 12, 2024 · Open, Classified
  Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)
• Z-1927-2008 · May 9, 2008 · Terminated
  Medtronic Arterial Cannula Curved Beveled Tip, for Cardiopulmonary Bypass. Catalog Numbers: CB81120 and CB87022.