DLP™ 77116Recalls & reported problems
Medtronic, Inc. · CANNULA 77116 ART ONE PIECE 16FR 5PK 17 · Class 2
All models of DLP (151)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20763000091204), received between Aug 14, 2025 and Sep 4, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (2 reports).
2 other recalls cover devices cleared under the same FDA submission (K024069); 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.
Reports received per month
Most reported problems
Device problems
- Material Deformation2
- Mechanical Problem2
- Misassembled During Installation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2025Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation
IT WAS REPORTED THAT DURING USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, THERE WAS DIFFICULTY INSERTING THE CANNULA AND THE TIP IS NOT ROUNDED. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS NOT HEATED OR COOLED BEFORE USE. THE SAME INSERTION SITE WAS USED FOR THE REPLACED CANNULA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22961461 ↗MalfunctionAug 14, 2025Mechanical Problem; Material Deformation; Misassembled During Installation; Mechanical Problem; Material Deformation; Misassembled During Installation
IT WAS REPORTED THAT THE ARTERIAL CANNULA WAS DIFFICULT TO INSERT BECAUSE THE TIP IS NOT ROUNDED. THE CUSTOMER REPORTED ARTERIAL CAN NULATION FAILURE AND STATED THAT THE MANDREL IS MOBILE AND SINKS INTO THE LUMEN OF THE CANNULA AT THE SLIGHTEST PRESSURE. THE CUSTOMER ATTEMPTED TO REPOSITION AFTER RE-BLOCKING THE MANDREL, THEN PERFORMED A CANNULATION WITH A CANNULA OF THE SAME RANGE BUT IN A SMA LLER SIZE. THERE WERE NO KNOWN PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22803836 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K024069. One submission often covers many models, so check the product and lot details in each record.
- Z-2738-2026 · May 25, 2026 · Open, ClassifiedMedtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula
- Z-0984-2025 · Dec 12, 2024 · Open, ClassifiedDLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Other Catheter, cannula and tubing, vascular, cardiopulmonary bypass devices
- DLP™ 77010Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall154 reports
- EOPA™ 77422Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls19 reports
- DLP™ 77008Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls9 reports
- NA HY11W65R1Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls8 reports
- DLP® 12113Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls6 reports
- DLP® Aortic Root Cannula with Flow-Guard™ 11012Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS2 recalls5 reports
- EOPA™ 77622Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls4 reports
- NA HY11R00R6Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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