DLP® 10050Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20613994698272), received between Aug 7, 2024 and Oct 2, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (6 reports).

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 19, 2024Open, Classified

   Potential for unsealed sterile packing.

   Z-1804-2024 · Root cause: Process control · FDA record ↗

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.

• MalfunctionOct 2, 2024Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP CARDIAC SUCTION TUBE, IT WAS REPORTED THAT THERE WAS A BLOCKAGE IN THE DEVICE AND CARBON DIOXIDE WAS UNABLE TO FLOW THROUGH THE DEVICE. THE CUSTOMER CHECKED THE GAS LINE, FILTER AND TABLE TUBING. THE DEVICE WAS TESTED SEPARATELY AND FOUND TO BE OCCLUDED. ANOTHER DLP CARDIAC SUCTION TUBE WAS OBSERVED TO HAVE THE SAME ISSUE DURING USE. THE ISSUE ADDED ADDITIONAL TIME TO PROCEDURE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE OBSERVED TO EITHER OF THE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20350000 ↗
• MalfunctionOct 2, 2024Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP CARDIAC SUCTION TUBE, IT WAS REPORTED THAT THERE WAS A BLOCKAGE IN THE DEVICE AND CARBON DIOXIDE WAS UNABLE TO FLOW THROUGH THE DEVICE. THE CUSTOMER CHECKED THE GAS LINE, FILTER AND TABLE TUBING. THE DEVICE WAS TESTED SEPARATELY AND FOUND TO BE OCCLUDED. ANOTHER DLP CARDIAC SUCTION TUBE WAS OBSERVED TO HAVE THE SAME ISSUE DURING USE. THE ISSUE ADDED ADDITIONAL TIME TO PROCEDURE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE OBSERVED TO EITHER OF THE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20349996 ↗
• MalfunctionOct 1, 2024Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP CARDIAC SUCTION TUBE, IT WAS REPORTED THAT THE LUMEN OF THE SUCTION TUBE APPEARED TO BE BLOCKED AS IT WOULD NOT SUCK. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. THE CUSTOMER STATED THEY HAVE ANOTHER DEVICE FROM THE SAME LOT THAT WAS NOT WORKING IN THE OR. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ISSUE WITH THE SECOND DEVICE WAS OBSERVED DURING TESTING PRIOR TO USE SINCE THE FIRST ONE FAILED TO WORK. THE ALLEGED ISSUE FOR THE SECOND DEVICE WAS THAT THE DEVICE DID NOT SUCK. THERE WAS NO DAMAGE OBSERVED TO EITHER OF THE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20342417 ↗
• MalfunctionOct 1, 2024Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP CARDIAC SUCTION TUBE, IT WAS REPORTED THAT THE LUMEN OF THE SUCTION TUBE APPEARED TO BE BLOCKED AS IT WOULD NOT SUCK. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.  THE CUSTOMER STATED THEY HAVE ANOTHER DEVICE FROM THE SAME LOT THAT WAS NOT WORKING IN THE OR. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ISSUE WITH THE SECOND DEVICE WAS OBSERVED DURING TESTING PRIOR TO USE SINCE THE FIRST ONE FAILED TO WORK. THE ALLEGED ISSUE FOR THE SECOND DEVICE WAS THAT THE DEVICE DID NOT SUCK. THERE WAS NO DAMAGE OBSERVED TO EITHER OF THE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20342113 ↗
• MalfunctionAug 7, 2024Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP CARDIAC SUCTION TUBE, IT WAS REPORTED THAT THE FINE SUCTION WAS NOT WORKING, AND CUSTOMER WAS UNABLE TO ASPIRATE ANY BLOCKAGES. ANOTHER FINE SUCTION WAS HANDED IN WITH THE SAME LOT NUMBER AND THE SAME ISSUE OCCURRED. THE DEVICE WAS REPLACED WITH ONE FROM A DIFFERENT LOT NUMBER TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER DOES NOT KNOW IF THE TUBING WAS BENT OR OCCLUDED. THE METAL TUBING IS MALLEABLE AND DESIGNED TO BE BENT TO THE SURGEON'S PREFERENCE. SINCE THERE WAS NO SUCTION, THE LUMEN APPEARED TO BE OCCLUDED SOMEWHERE INSIDE THE METAL OR PLASTIC TUBING. THE REPLACEMENT FROM A DIFFERENT LOT WORKED FINE, SO LIKELY THIS WAS NOT USER ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19929641 ↗
• MalfunctionAug 7, 2024Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP CARDIAC SUCTION TUBE, IT WAS REPORTED THAT THE FINE SUCTION WAS NOT WORKING, AND CUSTOMER WAS UNABLE TO ASPIRATE ANY BLOCKAGES. ANOTHER FINE SUCTION WAS HANDED IN WITH THE SAME LOT NUMBER AND THE SAME ISSUE OCCURRED. THE DEVICE WAS REPLACED WITH ONE FROM A DIFFERENT LOT NUMBER TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER DOES NOT KNOW IF THE TUBING WAS BENT OR OCCLUDED. THE METAL TUBING IS MALLEABLE AND DESIGNED TO BE BENT TO THE SURGEON'S PREFERENCE. SINCE THERE WAS NO SUCTION, THE LUMEN APPEARED TO BE OCCLUDED SOMEWHERE INSIDE THE METAL OR PLASTIC TUBING. THE REPLACEMENT FROM A DIFFERENT LOT WORKED FINE, SO LIKELY THIS WAS NOT USER ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19929468 ↗