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DLP® 10053Recalls & reported problems

Medtronic, Inc. · SUCTION 10053 6F SHAFT 10FR SOFT TIP 17L · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20613994698333), received between Aug 13, 2020 and May 24, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. 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

Device problems

  • Detachment of Device or Device Component1
  • Material Separation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionMay 24, 2022Material Separation; Material Separation

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP CARDIAC SUCTION TUBE, IT WAS REPORTED THAT THE SOFT PLASTIC BLUE SUCTION TIP FELL OFF.  USE OF THE SUCTION TUBE WAS REQUESTED BUT THE INFORMATION WAS NOT PROVIDED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED REGARDING WHETHER DAMAGE TO THE TIP WAS OBSERVED, IF THE TIP FELL INTO THE PATIENT AND HOW THE TIP WAS REMOVED IF IT FELL IN BUT THE CUSTOMER REFUSED TO PROVIDE ADDITIONAL INFORMATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14488949 ↗
  • MalfunctionAug 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A 10053 DLP CANNULA THE SILICON TIP CAME OFF DURING THE PROCEDURE. IT IS SUSPECTED THAT WHILE A PA WAS CLEANING THE TIP EXTERNAL OF THE PATIENT TO REMOVE A CLOG, THE TIP CAME OFF. THE TIP WAS SUBSEQUENTLY LOCATED AT THE END OF THE PROCEDURE, AND THERE WAS NO HARM TO THE PATIENT. IT WAS ASKED BUT UNKNOWN WHERE THE TIP WAS LOCATED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10400842 ↗

Other SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS devices

All SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.