DLP® 66116Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20613994878513), received between Jun 15, 2018 and Aug 16, 2026 — classified as 1 injury, 4 malfunctions.

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

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

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2026Material Deformation

  Medtronic received information that prior to use of a DLP Single Stage Venous Cannulae, it was reported that the distal tip of the venous cannula was ruptured. The device was replaced. There was no patient involvement, so no adverse effect occurred.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50268251 ↗
• MalfunctionSep 9, 2025Crack; Material Puncture/Hole; Crack; Material Puncture/Hole

  IT WAS REPORTED THAT DURING USE THE SINGLE STAGE VENOUS CANNULA WAS CUT AT THE PLACE WHERE THE SURGEON LACQUERED THE VEIN AFTER BEING PLACED IN THE PATIENT'S INFERIOR VENA CAVA. THE USE OF THE DEVICE WAS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23002865 ↗
• MalfunctionOct 18, 2021Material Puncture/Hole; Air/Gas in Device; Material Puncture/Hole; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP SINGLE STAGE VENOUS CANNULA, THE CUSTOMER REPORTED THAT A BREAK/HOLE IN THE CANNULA WAS NOTED. THE CANNULA WAS SUTURED TO THE STERNAL RETRACTOR WITH THE 1ST SUTURE, APPROX. 5-7 CM UP FROM THE TIP. THIS CAUSED THE CANNULA TO SUCK AIR DURING USE. AFTER TWO HOURS OF PERFUSION AND AFTER WEANING THE PATIENT, THE STAFF INVOLVED SAW A LARGE HOLE IN THE VENOUS CANNULA. THE VENOUS CANNULA WAS ALMOST COMPLETELY DIVIDED INTO TWO PARTS. THE SUTURE WAS LOOSELY TIED TO THE CANNULA AND THE STERNUM RETRACTOR. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647715 ↗
• InjuryOct 18, 2021Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP SINGLE STAGE VENOUS CANNULA, THE CUSTOMER REPORTED THAT A BREAK/HOLE IN THE CANNULA WAS NOTED. AFTER CANNULATION, WHEN THE CANNULA WAS ATTACHED TO THE STERNAL RETRACTOR WITH THE 1ST SUTURE, APPROX. 5-7 CM UP FROM THE TIP, A HOLE WAS IDENTIFIED IN THE CANNULA, WHICH CAUSED THE CANNULA TO SUCK AIR DURING USE.. THE DEVICE WAS NOT REPLACED, THE CANNULA WAS REATTACHED AND THE HOLE WAS COVERED WITH TAPE/PLASTIC TO PREVENT LEAKAGE. THE SUTURE WAS LOOSELY TIED TO THE CANNULA AND THE STERNUM RETRACTOR. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647622 ↗
• MalfunctionJun 15, 2018Split; Split

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THE SINGLE STAGE VENOUS CANNULA, WHILE FIXING THE CANNULA WITH A SILK THREAD THE CANNULA BROKE-UP (SPLIT) NOT ALLOWING A SEALED ENVIRONMENT. THE PRODUCT WAS REPLACED. THERE WAS NO ADVERSE EFFECT ON THE PATIENT. THE PROCEDURE TOOK LONGER DUE THE CANNULA BEEN REPLACED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 7604563 ↗

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.