DLP® 96428Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20613994556701), received between Feb 7, 2023 and Feb 27, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K875353); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2023Component Missing; Component Missing

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE, OF A DLP FEMORAL VENOUS CANNULA, IT WAS REPORTED THAT THE CANNULA HAD RELIEF PROBLEMS AND AFTER REMOVAL OF THE CANNULA IT BECAME APPARENT THAT THE LATERAL PERFORATIONS WERE COMPLETELY ABSENT. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE WAS INSPECTED PRIOR TO USE BUT NOT IN DETAIL. IT WAS STATED THAT THERE WAS NO DAMAGE TO THE CANNULA BODY OR TIP. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE FLOW WAS LOWER THAN EXPECTED. THE CUSTOMER STATED THAT THE HOLES WERE MISSING FROM THE CANNULA. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER WAS ABLE TO GET A SUFFICIENT DRAINAGE IN TOTAL BY INSERTING ANOTHER CANNULA VIA THE SUPERIOR VENA CAVA. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SAME INSERTION SITE WAS NOT USED TO INSERT THE SECOND CANNULA. THE CUSTOMER CONFIRMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS BECAUSE OF THIS ISSUE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE INSERTION SITE WAS SUTURED WITH COMMON SUTURES. NO CLOSURE DEVICE WAS USED. A SECOND CANNULA WITH NO PERFORATIONS/HOLES WAS RETURNED TO THE ANALYSIS LAB. THIS SEC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16443381 ↗
• InjuryFeb 7, 2023Component Missing; Obstruction of Flow; Component Missing; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE, OF A DLP FEMORAL VENOUS CANNULA, IT WAS REPORTED THAT THE CANNULA HAD RELIEF PROBLEMS AND AFTER REMOVAL OF THE CANNULA IT BECAME APPARENT THAT THE LATERAL PERFORATIONS WERE COMPLETELY ABSENT. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE WAS INSPECTED PRIOR TO USE BUT NOT IN DETAIL. IT WAS STATED THAT THERE WAS NO DAMAGE TO THE CANNULA BODY OR TIP. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE FLOW WAS LOWER THAN EXPECTED. THE CUSTOMER STATED THAT THE HOLES WERE MISSING FROM THE CANNULA. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER WAS ABLE TO GET A SUFFICIENT DRAINAGE IN TOTAL BY INSERTING ANOTHER CANNULA VIA THE SUPERIOR VENA CAVA. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SAME INSERTION SITE WAS NOT USED TO INSERT THE SECOND CANNULA. THE CUSTOMER CONFIRMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS BECAUSE OF THIS ISSUE. A SECOND CANNULA WITH NO PERFORATIONS/HOLES WAS RETURNED TO THE ANALYSIS LAB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16311613 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K875353. One submission often covers many models, so check the product and lot details in each record.

• Z-1914-2015 · Jun 12, 2015 · Terminated
  Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Kit, Models 96017 and 96021. Sterilized using Ethylene Oxide. The can