Select Series® 72424Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20643169485468), received between Feb 21, 2023 and Jan 22, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A SELECT SERIES ANGLED TIP ARTERIAL CANNULA, IT WAS REPORTED THAT AFTER OPENING THE OUTER PACKAGING, THE INNER PACKAGING BAG WAS FOUND TO BE DAMAGED. THE CUSTOMER STATED THAT THE ISSUE MAY HAVE LED TO A CONTAMINATION RISK. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24143275 ↗
• MalfunctionSep 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE SELECT SERIES ANGLED TIP ARTERIAL CANNULA CAME APART DURING PREPARATION FOR CANNULATION. THE CUSTOMER INDICATED THAT THE CANNULA HAD BEEN STORED WITH OTHER CANNULAE AND ITS USAGE DID NOT DIFFER FROM THEIR NORMAL ROUTINE. THE PRODUCT WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23049541 ↗
• MalfunctionAug 15, 2024Component Missing; Component Missing

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A SELECT SERIES ANGLED TIP ARTERIAL CANNULA DEVICE, IT WAS REPORTED THAT THE DEVICE WAS MISSING A PORT CAP. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19989725 ↗
• MalfunctionFeb 21, 2023Air/Gas in Device; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A SELECT SERIES ANGLED TIP ARTERIAL CANNULA, IT WAS REPORTED THE CUSTOMER DISCOVERED AIR BUBBLES INSIDE CANNULA DURING AORTIC CANNULATION. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO HOLES OR BREAKS IN THE CANNULA OBSERVED BY THE CUSTOMER. THE CANNULA APPEARED TO BE IN GOOD CONDITION. THE BUBBLES WERE INSIDE THE CANNULA IN THE PATIENT¿S BLOOD. THE CUSTOMER TRIED THEIR BEST TO REMOVE THE BUBBLES. THE CUSTOMER DID NOT SEE ANY BUBBLES AFTER THEY HAD TAPPED ON THE CANNULA TO REMOVE THE BUBBLES. THE CANNULA DID NOT PRIME ANY FASTER, IT PRIMED THE SAME AS USUAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16407067 ↗

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.