DLP™ 77110Recalls & reported problems
Medtronic, Inc. · CANNULA 77110 ART ONE PIECE 10FR 5PK 17 · Class 2
All models of DLP (151)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
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 20763000091174), received between Aug 14, 2025 and Aug 14, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Mar 19, 2024Open, Classified
Potential for unsealed sterile packing.
Z-1793-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Air/Gas in Device2
- Material Separation2
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.
MalfunctionAug 14, 2025Material Separation; Air/Gas in Device; Material Separation; Air/Gas in Device
IT WAS REPORTED THAT THESE DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULAE WERE OBSERVED TO HAVE AN EXPOSED WIRE ALONG THE SIDE OF THE CANNULAE BODY PRIOR TO USE. THE CUSTOMER OPENED THE ITEM AND NOTICED THE WIRE DID NOT APPEAR AS IT NORMALLY DID. ANOTHER CANNULA FROM THE SAME LOT NUMBER EXHIBITED THE SAME ISSUE, WHILE A CANNULA FROM A DIFFERENT LOT NUMBER APPEARED NORMAL. THE DEVICES WERE REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22803243 ↗MalfunctionAug 14, 2025Material Separation; Air/Gas in Device; Material Separation; Air/Gas in Device
IT WAS REPORTED THAT THESE DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULAE WERE OBSERVED TO HAVE AN EXPOSED WIRE ALONG THE SIDE OF THE CANNULAE BODY PRIOR TO USE. THE CUSTOMER OPENED THE ITEM AND NOTICED THE WIRE DID NOT APPEAR AS IT NORMALLY DID. ANOTHER CANNULA FROM THE SAME LOT NUMBER EXHIBITED THE SAME ISSUE, WHILE A CANNULA FROM A DIFFERENT LOT NUMBER APPEARED NORMAL. THE DEVICES WERE REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22803235 ↗
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 · each recall links to the FDA recall notice
- 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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