NA EL240Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994842916), received between Jan 21, 2026 and Jan 21, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (6 reports).

1 other recall cover devices cleared under the same FDA submission (K930154); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE EL RESERVOIRS, IT WAS REPORTED THAT ALL SIX DEVICES INSIDE THE PACK OF THE DEVICES WERE DAMAGED. A SMALL HOLE WAS IDENTIFIED IN THE PACKAGINGS. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT ONLY THE PACKAGING OF THE DEVICES WAS DAMAGED. THERE WAS NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGES. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICES WERE STILL LOCATED IN THE 'SEAL' OF THE PACKAGING WHEN THE ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24134024 ↗
• MalfunctionJan 21, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE EL RESERVOIRS, IT WAS REPORTED THAT ALL SIX DEVICES INSIDE THE PACK OF THE DEVICES WERE DAMAGED. A SMALL HOLE WAS IDENTIFIED IN THE PACKAGINGS. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT ONLY THE PACKAGING OF THE DEVICES WAS DAMAGED. THERE WAS NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGES. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICES WERE STILL LOCATED IN THE 'SEAL' OF THE PACKAGING WHEN THE ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24133826 ↗
• MalfunctionJan 21, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE EL RESERVOIRS, IT WAS REPORTED THAT ALL SIX DEVICES INSIDE THE PACK OF THE DEVICES WERE DAMAGED. A SMALL HOLE WAS IDENTIFIED IN THE PACKAGINGS. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT ONLY THE PACKAGING OF THE DEVICES WAS DAMAGED. THERE WAS NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGES. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICES WERE STILL LOCATED IN THE 'SEAL' OF THE PACKAGING WHEN THE ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24133767 ↗
• MalfunctionJan 21, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE EL RESERVOIRS, IT WAS REPORTED THAT ALL SIX DEVICES INSIDE THE PACK OF THE DEVICES WERE DAMAGED. A SMALL HOLE WAS IDENTIFIED IN THE PACKAGINGS. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT ONLY THE PACKAGING OF THE DEVICES WAS DAMAGED. THERE WAS NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGES. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICES WERE STILL LOCATED IN THE 'SEAL' OF THE PACKAGING WHEN THE ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24133743 ↗
• MalfunctionJan 21, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE EL RESERVOIRS, IT WAS REPORTED THAT ALL SIX DEVICES INSIDE THE PACK OF THE DEVICES WERE DAMAGED. A SMALL HOLE WAS IDENTIFIED IN THE PACKAGINGS. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT ONLY THE PACKAGING OF THE DEVICES WAS DAMAGED. THERE WAS NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGES. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICES WERE STILL LOCATED IN THE 'SEAL' OF THE PACKAGING WHEN THE ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24133725 ↗
• MalfunctionJan 21, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE EL RESERVOIRS, IT WAS REPORTED THAT ALL SIX DEVICES INSIDE THE PACK OF THE DEVICES WERE DAMAGED. A SMALL HOLE WAS IDENTIFIED IN THE PACKAGINGS. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT ONLY THE PACKAGING OF THE DEVICES WAS DAMAGED. THERE WAS NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGES. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICES WERE STILL LOCATED IN THE 'SEAL' OF THE PACKAGING WHEN THE ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24133700 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K930154. One submission often covers many models, so check the product and lot details in each record.

• Z-0477-2008 · Oct 1, 2007 · Terminated
  Medtronic Blood Collection Reservoir, 40 micron,Catalog/Model # EL240, Medtronic, Inc., Minneapolis, MN 55432-5804