DLP® 14000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20613994619710), received between Jun 30, 2023 and Jul 3, 2023 — classified as 2 malfunctions.

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.

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.

Recalls naming this device

1. Mar 19, 2024Open, Classified

   Potential for unsealed sterile packing.

   Z-1801-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP 14000 MULTIPLE PERFUSION SET, ONCE PRIMING BEGAN IT BEGAN TO LEAK ABOUT 1CM FROM THE FEMALE LUER. IT WAS REMOVED AND CHANGED OUT FOR A DIFFERENT 14000 AND THE CASE PROCEEDED WITHOUT INCIDENT. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION FROM THE SALES REP: THE DEVICE WAS SET UP NORMALLY- THE PACKAGING WAS UNCUT AND INTACT. THE OUTER BOX HAD BEEN DISCARDED. THE ADAPTER SET WAS CONNECTED TO THE PATIENT WHEN THE LEAK OCCURRED. SEE MPXR 809932 (PE 704242271) FOR ANOTHER SIMILAR EVENT FROM THE SAME FACILITY AND LOT NUMBER. SINCE TWO EVENTS HAPPENED WITH THE SAME 2020100101 LOT (SEE MPXR 809932), THE SALES REP HAS CHOSEN TO REMOVE THE ENTIRE LOT FROM THE HOSPITAL. BEING RETURNED UNDER THIS MPXR 809886 ARE SEVEN 14000, ONE WHICH LEAKED IN THIS REPORT, ONE WHICH WAS OPENED AND EXAMINED BY THE STAFF AT THE HOSPITAL, AND FIVE OTHERS THAT THE SALES REP REMOVED. ALL DEVICES CAN BE USED IN THE INVESTIGATION. ADDITIONAL INFORMATION: ALMOST NO BLOOD WAS LOST. CERTAINLY 5CC. NO TRANSFUSION WAS NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17246026 ↗
• MalfunctionJun 30, 2023Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP 14000 MULTIPLE PERFUSION SET, WHEN BLOOD CARDIOPLEGIA WAS BEING GIVEN, AN UNKNOWN VOLUME BEGAN LEAKING FROM A HOLE IN THE TUBING ABOUT 1CM FROM THE FEMALE LUER CONNECTION. NO BLOOD LOSS ESTIMATE WAS GIVEN, BUT IT WAS NOT CLINICALLY SIGNIFICANT. IT WAS NOT NOTICED RIGHT AWAY, AND WHEN IT WAS NOTICED, DELIVERY WAS STOPPED AND THE 14000 CHANGED OUT. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION: THE DEVICE WAS SET UP NORMALLY. THE PACKAGING WAS UNCUT AND INTACT. THE OUTER BOX HAD BEEN DISCARDED. THE CUSTOMER STATED THAT A TRANSFUSION WAS NOT REQUIRED AS A RESULT OF THE LEAK AND THERE WAS NO VISIBLE AIR IN THE SYSTEM. SEE MPXR 809886 (PE 704242277) FOR ANOTHER SIMILAR EVENT FROM THE SAME FACILITY AND LOT NUMBER. INVENTORY WAS REMOVED AND RETURNED FOR ANALYSIS UNDER THAT PE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17238715 ↗