DLP® 30050Recalls & reported problems
Medtronic, Inc. · CANNULA 30050 COR SOFT CONCAVE 10PK 17L · 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 20613994576013), received between May 12, 2025 and Nov 24, 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.
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-1795-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Deformation2
- Contamination1
- Material Puncture/Hole1
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.
MalfunctionNov 24, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING CARDIOPULMONARY BYPASS, THE DLP CORONARY ARTERY OSTIAL CANNULA WAS USED TO DELIVER CARDIOPLEGIA INTO THE AORTIC OSTIA. AFTER ADMINISTRATION, THE CANNULA WAS STORED STILL ATTACHED TO THE CARDIOPLEGIA DELIVERY LINE IN THE TABLE SIDE POCKET, AND WHEN A SECOND DOSE WAS NEEDED, DEFORMATION OF THE CANNULA SILICONE TIP WAS OBSERVED. INSPECTION OF THE STORAGE AREA REVEALED NO FLUID OR OTHER SUBSTANCES THAT COULD HAVE AFFECTED THE CANNULA, AND THERE WAS NO NOTED DAMAGE TO THE CANNULA DURING THE FIRST ADMINISTRATION. THE CANNULA WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23629484 ↗MalfunctionMay 12, 2025Contamination; Material Puncture/Hole; Material Deformation; Contamination; Material Puncture/Hole; Material Deformation
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP CORONARY ARTERY OSTIAL CANNULA, IT WAS REPORTED THAT FOREIGN MATERIAL WAS IDENTIFIED AT THE PILLOW TIP. THE STERILE BARRIER WAS NOT SEALED, THE DAMAGED SEEMED MORE LIKE MORPHED/ MELTED ISSUE AT THE TIP. THERE WAS NO DAMAGE TO THE PACKAGE, AND NO OTHER DEVICE IN THE PACKAGE WAS DAMAGED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22002740 ↗
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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