DLP® 30000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20613994646211), received between Oct 3, 2023 and Mar 6, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K810820); 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. Feb 7, 2024Open, Classified

   Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed above.

   Z-1316-2024 · Root cause: Packaging change 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.

• MalfunctionMar 6, 2024Wrong Label; Wrong Label

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP VESSEL CANNULA, THE CUSTOMER REPORTED THAT THE TIP HAD A STRAIGHT AND ROBUST CUT, INSTEAD OF A BEVEL SHAPE, AS USUAL. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT X-MED LOOKED THROUGH ALL OF THE BOXES/INVENTORY FOR THE COMPLAINT LOT 2023020890.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18844554 ↗
• MalfunctionOct 18, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP VESSEL CANNULA , THE CUSTOMER REPORTED THAT WHEN USING THE VEIN TIP, IT WAS OBSERVED THAT THE TIP HAD A STRAIGHT AND ROBUST CUT, INSTEAD OF THE USUAL BEVEL SHAPE, MAKING IT DIFFICULT TO ENTER THE VESSEL (SAPHENOUS VEIN), ANOTHER UNIT OF MATERIAL WAS OPENED, HOWEVER THE OTHER HAD THE SAME CHARACTERISTICS, MAKING THE SURGICAL TECHNIQUE DIFFICULT. THE CUSTOMER HAD TO MAKE AN ADAPTATION TO INSERT THE TIP INTO THE LUMEN OF THE VESSEL. THE DEVICE WAS REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WERE NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17955314 ↗
• MalfunctionOct 18, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP VESSEL CANNULA, THE CUSTOMER REPORTED THAT WHEN USING THE VEIN TIP, IT WAS OBSERVED THAT THE TIP HAD A STRAIGHT AND ROBUST CUT, INSTEAD OF THE USUAL BEVEL SHAPE, MAKING IT DIFFICULT TO ENTER THE VESSEL (SAPHENOUS VEIN), ANOTHER UNIT OF MATERIAL WAS OPENED, HOWEVER THE OTHER HAD THE SAME CHARACTERISTICS, MAKING THE SURGICAL TECHNIQUE DIFFICULT. THE CUSTOMER HAD TO MAKE AN ADAPTATION TO INSERT THE TIP INTO THE LUMEN OF THE VESSEL. THE DEVICE WAS REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WERE NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17955215 ↗
• MalfunctionOct 3, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP VESSEL CANNULA, THE CUSTOMER REPORTED THAT WHEN USING THE VEIN TIP, IT WAS OBSERVED THAT THE TIP HAD A STRAIGHT AND ROBUST CUT, INSTEAD OF THE USUAL BEVEL SHAPE, MAKING ENTRY INTO THE VESSEL (SAPHENOUS VEIN) DIFFICULT. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17859318 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K810820. One submission often covers many models, so check the product and lot details in each record.

• Z-1799-2024 · Mar 19, 2024 · Open, Classified
  Medtronic Vessel Cannulae: a) DLP 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP 3 mm Vessel Cannula Blunt Tip, Model Number 30003
• Z-1796-2024 · Mar 19, 2024 · Open, Classified
  Medtronic I.M.A. Cannulae: DLP 1 mm Arteriotomy Cannula, Model Number 31001