DLPRecalls & reported problems across all models
Medtronic, Inc. · 151 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
27 open recalls name at least one DLP model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 592
- Deaths reported
- 4
- Injuries reported
- 26
- Recalls
- 32
We found 151 models of DLP by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 592 adverse event reports in the FDA's MAUDE database, received between Jan 13, 2017 and Sep 29, 2026 — classified as 4 deaths, 26 injuries, 562 malfunctions.
The most frequently reported specific device problem is “Material Separation” (290 reports).
32 FDA recall records name at least one of these models by its device identifier, 27 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
DLP recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 25, 2026Open, Classified
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
Z-2738-2026 · Root cause: Packaging · Recall details · FDA record ↗
- Apr 21, 2026Open, Classified
Certain lots of product have the potential for a sterile barrier breach.
Z-2222-2026 · Root cause: Packaging process control · Recall details · FDA record ↗
- Apr 21, 2026Open, Classified
Certain lots of product have the potential for a sterile barrier breach.
Z-2221-2026 · Root cause: Packaging process control · Recall details · FDA record ↗
- Apr 21, 2026Open, Classified
Certain lots of product have the potential for a sterile barrier breach.
Z-2220-2026 · Root cause: Packaging process control · Recall details · FDA record ↗
- Apr 21, 2026Open, Classified
Certain lots of product have the potential for a sterile barrier breach.
Z-2219-2026 · Root cause: Packaging process control · Recall details · FDA record ↗
- Apr 21, 2026Open, Classified
Certain lots of product have the potential for a sterile barrier breach.
Z-2218-2026 · Root cause: Packaging process control · Recall details · FDA record ↗
- Apr 21, 2026Open, Classified
Certain lots of product have the potential for a sterile barrier breach.
Z-2217-2026 · Root cause: Packaging process control · Recall details · FDA record ↗
- Apr 21, 2026Open, Classified
Certain lots of product have the potential for a sterile barrier breach.
Z-2216-2026 · Root cause: Packaging process control · Recall details · FDA record ↗
- Aug 6, 2025Open, Classified
The catheters may not retain their shape.
Z-2482-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Aug 6, 2025Open, Classified
The catheters may not retain their shape.
Z-2481-2025 · Root cause: Process change control · names 2 of these models · Recall details · FDA record ↗
- Aug 6, 2025Open, Classified
The catheters may not retain their shape.
Z-2480-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 12, 2024Open, Classified
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Z-0984-2025 · Root cause: Packaging · names 2 of these models · Recall details · FDA record ↗
- Jul 9, 2024Open, Classified
During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model 67312).
Z-3128-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 19, 2024Open, Classified
Potential for unsealed sterile packing.
Z-1805-2024 · Root cause: Process control · names 23 of these models · Recall details · FDA record ↗
- Mar 19, 2024Open, Classified
Potential for unsealed sterile packing.
Z-1804-2024 · Root cause: Process control · names 5 of these models · Recall details · FDA record ↗
- Mar 19, 2024Open, Classified
Potential for unsealed sterile packing.
Z-1802-2024 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
- Mar 19, 2024Open, Classified
Potential for unsealed sterile packing.
Z-1801-2024 · Root cause: Process control · names 7 of these models · Recall details · FDA record ↗
- Mar 19, 2024Open, Classified
Potential for unsealed sterile packing.
Z-1800-2024 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
- Mar 19, 2024Open, Classified
Potential for unsealed sterile packing.
Z-1799-2024 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
- Mar 19, 2024Open, Classified
Potential for unsealed sterile packing.
Z-1798-2024 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
- Mar 19, 2024Open, Classified
Potential for unsealed sterile packing.
Z-1797-2024 · Root cause: Process control · names 8 of these models · Recall details · FDA record ↗
- Mar 19, 2024Open, Classified
Potential for unsealed sterile packing.
Z-1796-2024 · Root cause: Process control · Recall details · FDA record ↗
- Mar 19, 2024Open, Classified
Potential for unsealed sterile packing.
Z-1795-2024 · Root cause: Process control · Recall details · FDA record ↗
- Mar 19, 2024Open, Classified
Potential for unsealed sterile packing.
Z-1793-2024 · Root cause: Process control · names 14 of these models · Recall details · FDA record ↗
- Feb 7, 2024Open, Classified
Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed above.
Z-1316-2024 · Root cause: Packaging change control · Recall details · FDA record ↗
- Aug 24, 2021Open, Classified
Potential for a wire protrusion through the left heart vent catheter tip
Z-2505-2021 · Root cause: Process control · Recall details · FDA record ↗
- Aug 24, 2021Open, Classified
Potential for a wire protrusion through the left heart vent catheter tip
Z-2504-2021 · Root cause: Process control · Recall details · FDA record ↗
- Jun 22, 2017Terminated
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
Z-2768-2017 · Root cause: Packaging process control · names 2 of these models · Recall details · FDA record ↗
- Jun 22, 2017Terminated
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
Z-2767-2017 · Root cause: Packaging process control · names 2 of these models · Recall details · FDA record ↗
- Jun 22, 2017Terminated
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
Z-2766-2017 · Root cause: Packaging process control · Recall details · FDA record ↗
…and 2 older recalls, listed on each model's page.
Most reported DLP problems
Device problems
- Material Separation290
- Contamination119
- Mechanical Problem107
- Material Deformation72
- Obstruction of Flow50
- Misassembled During Installation27
- Material Puncture/Hole23
- Fluid/Blood Leak18
Patient problems
- No Clinical Signs, Symptoms or Conditions561
- Hemorrhage/Blood Loss/Bleeding14
- No Consequences Or Impact To Patient5
- Foreign Body In Patient3
- Hypovolemia3
- Laceration(s)2
- No Known Impact Or Consequence To Patient2
- Perforation of Vessels2
DLP models
151 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- DLP™ 77010Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall154 reports
- DLP™ 77008Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls9 reports
- DLP® 12113Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls6 reports
- DLP® 67312CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS2 recalls1 report
- DLP® 62000GAUGE, PRESSURE, CORONARY, CARDIOPULMONARY BYPASS2 recalls0 reports
- DLP® 11001GAdaptor, stopcock, manifold, fitting, cardiopulmonary bypass2 recalls0 reports
- DLP® 25010CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS2 recalls0 reports
- DLP® 25009CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS2 recalls0 reports
- DLP® 12110Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall27 reports
- DLP™ 77010Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall10 reports
- DLP® 12116CATHETER, STEERABLE1 recall8 reports
- DLP® 10050SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS1 recall6 reports
- DLP® 24009CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall4 reports
- DLP® 20014CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS54 reports
- DLP® 30212CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS54 reports
- DLP® 30000CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall4 reports
- DLP® 12110Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall4 reports
- DLP® 31001CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall3 reports
- DLP® 12010CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall3 reports
- DLP® 12016CATHETER, STEERABLE1 recall2 reports
- DLP® 30050CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall2 reports
- DLP® 14000Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall2 reports
- DLP® 10052SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS1 recall2 reports
- DLP® 10053SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS1 recall2 reports
- DLP® 66128CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall2 reports
- DLP® 94915CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall2 reports
- DLP™ 77014Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall2 reports
- DLP™ 77110Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall2 reports
- DLP® 12002CATHETER, STEERABLE1 recall1 report
- DLP® 66132CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall1 report
- DLP® 69320CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall1 report
- DLP® 67318CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall1 report
- DLP® 68128CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall1 report
- DLP® 68120CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall1 report
- DLP® 12118CATHETER, STEERABLE1 recall1 report
- DLP® 94215TCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall1 report
- DLP® 94725CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall1 report
- DLP® 80220CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall1 report
- DLP® 80222CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall1 report
- DLP® 12115Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall1 report
- DLP™ 77006Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall1 report
- DLP® 12220CATHETER, STEERABLE1 recall0 reports
- DLP® 10060SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 10061APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED1 recall0 reports
- DLP® 79004CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY1 recall0 reports
- DLP® 79009CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY1 recall0 reports
- DLP® 12012CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 14003Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall0 reports
- DLP® 30004CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 30003CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 11316CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 13001Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall0 reports
- DLP® 10710Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall0 reports
- DLP® 13002Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall0 reports
- DLP® 61000GAUGE, PRESSURE, CORONARY, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 67520CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 67522CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 67524CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 67526CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 67528CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 67534CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 66118CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 66122CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 66130CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 66236CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 87122CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 87120CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 69331CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 67320CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 67316CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 68134CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 68130CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 68124CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 15004CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 94913LCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 94665CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 94913CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 94965CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 82020CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 87220CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 87222CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 80020CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 12001Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall0 reports
- DLP® 12008Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall0 reports
- DLP® 61000CONTAINER, SPECIMEN, STERILE1 recall0 reports
- DLP™ 77206Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall0 reports
- DLP™ 77112Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall0 reports
- DLP® 30112CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS41 reports
- DLP® 30155CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS16 reports
- DLP® 30012CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS16 reports
- DLP® 20012CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS11 reports
- DLP® 10062APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED7 reports
- DLP™ 77208Catheter, cannula and tubing, vascular, cardiopulmonary bypass7 reports
- DLP™ 77208Catheter, cannula and tubing, vascular, cardiopulmonary bypass7 reports
- DLP® 30014CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 death6 reports
- DLP® 20114WFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS5 reports
- DLP® 66116CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS5 reports
- DLP® 75318CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS5 reports
- DLP™ 77206Catheter, cannula and tubing, vascular, cardiopulmonary bypass5 reports
- DLP® 69328CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 death4 reports
Recent DLP adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929502 ↗MalfunctionSep 29, 2026Material Deformation
Medtronic received information that prior to use of a DLP single stage venous cannula with right angle metal tip, when the cannula was opened and the tip was tested, it was noted that the tip was not smooth. It was stated that the holes in the metal were also quite sharp. The device was replaced. There was no patient involvement, so no adverse effect occurred.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929025 ↗MalfunctionSep 29, 2026Material Puncture/Hole
It was reported that prior to use, the DLP Single Stage Venous Cannula with Right Angle Metal Tip was opened and its tip appeared sharp where the holes were drilled. The cannula was not used and was replaced with another product. There was no patient involved.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928661 ↗MalfunctionSep 29, 2026Material Puncture/Hole
It was reported that prior to use of a the DLP Single Stage Venous Cannula with Right Angle Metal the holes were too sharp and not rounded as usual, making the cannula too sharp for customer use. The cannula was replaced by a Medtronic product. There was no patient involved.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928489 ↗MalfunctionSep 29, 2026Material Puncture/Hole
It was reported that, upon opening the DLP Single Stage Venous Cannula with Right Angle Metal Tip prior to use, the cannula tip at the drilled holes felt sharp. The cannula was not used and was replaced with a Medtronic product. There was no patient involved.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928436 ↗MalfunctionSep 28, 2026Material Separation
Medtronic received information that during use of a DLP coronary artery ostial cannula, it was reported that the connector was not fully secured to the metal tubing. During use, the connector became loose and detached from the metal tubing. The use of the device was unspecified. There was no reported adverse patient effect associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912804 ↗MalfunctionSep 1, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50537757 ↗MalfunctionAug 18, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50300038 ↗MalfunctionAug 17, 2026Material Deformation
Medtronic received information that prior to use of a DLP Aortic Root Cannula with a Vent Line, it was reported that the device was deformed, the sewing flange was bent/ curved downward towards the needle, and they should be flat. There was no damage to the packaging, and no other devices in the same box/shipping container were damaged. See attached photos. The device was not used. There was no patient involvement, so no adverse effect occurred.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50277083 ↗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 ↗MalfunctionJun 2, 2026Material Separation
IT WAS REPORTED THAT PRIOR TO USE OF THE DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULAE, DUST AND PARTICLES WERE FOUND INSIDE THE STERILE PACKAGE AND ONE OF THE CANNULAE HAD LOOSE CAPS. THE DEVICES WERE NOT USED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25360877 ↗MalfunctionMay 1, 2026Obstruction of Flow
MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP CORONARY ARTERY OSTIAL CANNULA, IT WAS REPORTED THAT DURING A MVR (MITRAL VALVE REPLACEMENT), AVR (AORTIC VALVE REPLACEMENT) AND LAA (LEFT ATRIAL APPENDAGE) IN A YOUNG PATIENT, THERE WAS A LARGE ANTEGRADE DOSE WITH QUICK ARREST AT THE ONSET OF THE CASE. AI (AORTIC INSUFFICIENCY) OSTIAL PLEGIA WAS DELIVERED FOR MOST OF THE CASE. THE SURGICAL PREFERENCE WAS TO UTILIZE TWO SEPARATE HANDHELD DLP 30014 DEVICES FOR THE RIGHT AND LEFT OSTIA'S. THE CUSTOMER STARTED BY INITIATING THE RIGHT, THEN UNCLIPPED THE LEFT. THE CORONARY ANATOMY WAS NON-REMARKABLE. THE SURGEON CHECKED THE MYOCARDIAL TEMPERATURE MANUALLY FROM TIME TO TIME AND FOUND THE LV (LEFT VENTRICLE) TEMPERATURE SATISFACTORY, BUT AFTER UNCLAMPING, THE HEART WENT INTO INTRACTABLE VT (VENTRICULAR TACHYCARDIA) WITH AN AKINETIC LV (LEFT VENTRICLE). EVENTUALLY THE CUSTOMER RE-CLAMPED, GAVE PLEGE AND THE LV (LEFT VENTRICLE) RECOVERED TO SUPPORT OFF PUMP, ALTHOUGH THE PATIENT LUNGS WERE FLOODED IN THE PROCESS. THE PATIENT HAS AN OPEN STERNUM ON VV ECMO (VENO-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION) CURRENTLY. AFTER THE CUSTOMER RE-CLAMPED, THEY FOUND THE LIKELY CULPRIT OF THE PR
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25054789 ↗MalfunctionApr 23, 2026Obstruction of Flow
IT WAS REPORTED THAT DURING APPROXIMATELY 3 HOURS OF CANNULATION WITH THE DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT ANGLE METAL TIP, A CLOTTING ISSUE WAS OBSERVED. NO DAMAGE TO THE CANNULA BODY OR TIP WAS IDENTIFIED. HEPARIN WAS THE ANTICOAGULANT THAT WAS USED. THE USE OF THE DEVICE WAS UNSPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24963285 ↗MalfunctionApr 14, 2026Crack; Material Puncture/Hole
MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP AORTIC ROOT CANNULA WITH VENT LINE, THE CUSTOMER REPORTED A CRACK/BREAK/HOLE AT THE CANNULA TIP. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24871089 ↗MalfunctionApr 2, 2026Material Deformation
IT WAS REPORTED THAT, PRIOR TO USE, A DLP SINGLE STAGE VENOUS CANNULA WAS OBSERVED TO HAVE AN OBVIOUS DENT IN THE CANNULA. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24762539 ↗
Other Medtronic, Inc. products
- CapSureFix Novus MRI SureScan29 models · 87,337 reports
- Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
- Intellis AdaptiveStim3 models · 35,469 reports
- SYNCHROMED II11 models · 32,260 reports · 4 recalls
- CAPSUREFIX NOVUS17 models · 27,547 reports
- INTERSTIM30 models · 24,415 reports · 1 recall
- Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
- Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page