DLP® 66128Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20613994878575), received between Aug 20, 2025 and Aug 20, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

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

3 other recalls cover devices cleared under the same FDA submission (K845045); 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.

Recalls naming this device

1. Mar 19, 2024Open, Classified

   Potential for unsealed sterile packing.

   Z-1805-2024 · 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.

• MalfunctionAug 20, 2025Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  IT WAS REPORTED THAT DURING USE OF DLP SINGLE STAGE VENOUS CANNULAE, THE DEVICES WERE USED FOR BI-CAVAL CANNULATION FOR A MITRAL VALVE OPERATION. AT THE END OF THE PROCEDURE, IT WAS NOTICED THAT THERE WERE SIGNIFICANT MARKS ON ONE OF THE CANNULA CONSISTENT TO WHERE THE TUBING CLAMP HAD BEEN APPLIED. THE MARKS APPEARED CONSISTENT WITH THE PATTERN ON THE TUBING CLAMP. AS EXPERIENCED USERS OF THIS CANNULA, THE CUSTOMER HAD NOT OBSERVED THIS DEGREE OF INDENTATION ON THE CANNULA POST-PROCEDURE BEFORE. THE CUSTOMER SUGGESTED, BUT CANNOT CONFIRM, THAT THE TUBING ON THE CANNULA WAS SOFTER THAN USUAL. THE CANNULA WAS NOT PERFORATED, JUST MARKED. THE SAME METAL TUBING CLAMP WAS USED ON BOTH CANNULAE AND THE OTHER CANNULA (OF SAME LOT NUMBER) WAS NOT MARKED. THE CLAMP HAD BEEN USED FOR PREVIOUS OPERATIONS WITH THE SAME DEVICES. NO DAMAGE WAS SEEN TO ANY COMPONENTS OR PACKAGING BEFORE THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE AFFECTED CANNULA SO THERE WAS NO INTERRUPTION OR DELAY TO THE OPERATION. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULAE WERE NOT VISIBLY SOFTER. THE CANNULAE WERE NOT HEATED OR COOLED PRIOR TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22851450 ↗
• MalfunctionAug 20, 2025Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  IT WAS REPORTED THAT DURING USE OF DLP SINGLE STAGE VENOUS CANNULAE, THE DEVICES WERE USED FOR BI-CAVAL CANNULATION FOR A MITRAL VALVE OPERATION. AT THE END OF THE PROCEDURE, IT WAS NOTICED THAT THERE WERE SIGNIFICANT MARKS ON ONE OF THE CANNULA CONSISTENT TO WHERE THE TUBING CLAMP HAD BEEN APPLIED. THE MARKS APPEARED CONSISTENT WITH THE PATTERN ON THE TUBING CLAMP. AS EXPERIENCED USERS OF THIS CANNULA, THE CUSTOMER HAD NOT OBSERVED THIS DEGREE OF INDENTATION ON THE CANNULA POST-PROCEDURE BEFORE. THE CUSTOMER SUGGESTED, BUT CANNOT CONFIRM, THAT THE TUBING ON THE CANNULA WAS SOFTER THAN USUAL. THE CANNULA WAS NOT PERFORATED, JUST MARKED. THE SAME METAL TUBING CLAMP WAS USED ON BOTH CANNULAE AND THE OTHER CANNULA (OF SAME LOT NUMBER) WAS NOT MARKED. THE CLAMP HAD BEEN USED FOR PREVIOUS OPERATIONS WITH THE SAME DEVICES. NO DAMAGE WAS SEEN TO ANY COMPONENTS OR PACKAGING BEFORE THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE AFFECTED CANNULA SO THERE WAS NO INTERRUPTION OR DELAY TO THE OPERATION. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULAE WERE NOT VISIBLY SOFTER. THE CANNULAE WERE NOT HEATED OR COOLED PRIOR TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22851320 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K845045. One submission often covers many models, so check the product and lot details in each record.

• Z-0812-2012 · Dec 14, 2011 · Terminated
  Medtronic, Single Stage Venous Cannula, Carmeda Bio-Active Surface Venous Cannula, Sterilized Using Ethylene Oxide, Rx Only, Nonpyrogenic. Model # 's CB66112, CB66114, CB66116,
• Z-0808-2012 · Dec 14, 2011 · Terminated
  Medtronic DLP, DLP Single Stage Venous Cannulae. Rx Only, Sterile EO, Nonpyrogenic. Model #'s 66112, 66114, 66116, 66118, 66120, 66122, 66124, 66126, 66128, 66130, 66132, 66134,
• Z-1489-04 · Sep 15, 2004 · Terminated
  Medtronic DLP VAD Venous Cannula for Ventricular Assist, Models 95036 and CB95036.