Select Series® 72422Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20643169485970), received between Jun 22, 2023 and Oct 7, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

2 FDA recall records name this device's identifier, 2 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. Dec 12, 2024Open, Classified

   Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.

   Z-0986-2025 · Root cause: Packaging · FDA record ↗

2. Dec 12, 2024Open, Classified

   Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.

   Z-0985-2025 · Root cause: Packaging · 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.

• MalfunctionOct 7, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A SELECT SERIES ANGLED TIP ARTERIAL CANNULA, IT WAS REPORTED THAT THE MODEL NUMBER ON THE OUTER PACKAGING OF THE PRODUCT WAS 72422 BUT AFTER THE CUSTOMER OPENED IT, THE MODEL NUMBER MARKED ON THE CANNULA BODY WAS 72424. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20381671 ↗
• MalfunctionJul 26, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A SELECT SERIES ANGLED TIP ARTERIAL CANNULA, IT WAS REPORTED THAT THE PRODUCT WAS DEFORMED. THE USE OF THE DEVICE IS UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17394961 ↗
• MalfunctionJun 22, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A SELECT SERIES ANGLED TIP ARTERIAL CANNULA, THE CUSTOMER REPORTED THE PRESENCE OF BULGING IN THE EXTENSION OF THE PRODUCT, MAKING IT IMPOSSIBLE TO USE. IT IS UNKNOWN IF THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17179798 ↗

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-1793-2024 · Mar 19, 2024 · Open, Classified
  Medtronic Arterial Cannulae packaged as: a) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80220
• Z-1927-2008 · May 9, 2008 · Terminated
  Medtronic Arterial Cannula Curved Beveled Tip, for Cardiopulmonary Bypass. Catalog Numbers: CB81120 and CB87022.