LauncherRecalls & reported problems across all models
Medtronic, Inc. · 64 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 132
- Deaths reported
- 2
- Injuries reported
- 61
- Recalls
- 0
We found 64 models of Launcher by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 132 adverse event reports in the FDA's MAUDE database, received between May 10, 2017 and Feb 13, 2026 — classified as 2 deaths, 61 injuries, 69 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (55 reports).
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
Most reported Launcher problems
Device problems
- Material Deformation55
- Adverse Event Without Identified Device or Use Problem27
- Detachment of Device or Device Component22
- Deformation Due to Compressive Stress18
- Use of Device Problem18
- Difficult to Remove16
- Device Dislodged or Dislocated4
- Entrapment of Device4
Patient problems
- No Clinical Signs, Symptoms or Conditions42
- No Consequences Or Impact To Patient29
- Insufficient Information21
- Vascular Dissection20
- Perforation6
- Myocardial Infarction5
- Obstruction/Occlusion5
- Patient Problem/Medical Problem5
Launcher models
64 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Launcher LA6JR40CATHETER, PERCUTANEOUS10 reports
- Launcher LA6IMAKCATHETER, PERCUTANEOUS9 reports
- Launcher LA6EBU35Catheter, percutaneous9 reports
- Launcher LA6EBU35CATHETER, PERCUTANEOUS1 death5 reports
- LAUNCHER LA6EBU35Catheter, percutaneous5 reports
- Launcher LA6JR35CATHETER, PERCUTANEOUS4 reports
- Launcher LA6JL35CATHETER, PERCUTANEOUS4 reports
- Launcher LA6AL75CATHETER, PERCUTANEOUS4 reports
- Launcher LA7AL10CATHETER, PERCUTANEOUS4 reports
- Launcher LA6JL40CATHETER, PERCUTANEOUS3 reports
- Launcher LA6AR10CATHETER, PERCUTANEOUS3 reports
- Launcher LA7JL40CATHETER, PERCUTANEOUS3 reports
- Launcher LA7EBU30CATHETER, PERCUTANEOUS3 reports
- Launcher LA5JR40CATHETER, PERCUTANEOUS2 reports
- Launcher LA6JR35SHCATHETER, PERCUTANEOUS2 reports
- Launcher LA6MP1SHCATHETER, PERCUTANEOUS2 reports
- Launcher LA6MB2CATHETER, PERCUTANEOUS2 reports
- Launcher LA6EBU355CATHETER, PERCUTANEOUS2 reports
- Launcher LA6AL10CATHETER, PERCUTANEOUS2 reports
- Launcher LA6IMACATHETER, PERCUTANEOUS2 reports
- Launcher LA6EBU35SHCATHETER, PERCUTANEOUS2 reports
- Launcher LA6EBU375CATHETER, PERCUTANEOUS2 reports
- Launcher LA6ERADLCATHETER, PERCUTANEOUS2 reports
- Launcher LA7EBU35CATHETER, PERCUTANEOUS2 reports
- Launcher LA6JR40SHCatheter, percutaneous2 reports
- Launcher LA6JR40Catheter, percutaneous2 reports
- Launcher LA6JL40Catheter, percutaneous1 death2 reports
- Launcher LA6JR40Catheter, percutaneous2 reports
- Launcher LA5ALR12CATHETER, PERCUTANEOUS1 report
- Launcher LA6JR40SHCATHETER, PERCUTANEOUS1 report
- Launcher LA6JR50SHCATHETER, PERCUTANEOUS1 report
- Launcher LA6JR405CATHETER, PERCUTANEOUS1 report
- Launcher LA6MAC3030CATHETER, PERCUTANEOUS1 report
- Launcher LA6JL30CATHETER, PERCUTANEOUS1 report
- Launcher LA6RCBSHCATHETER, PERCUTANEOUS1 report
- Launcher LA6RDCKCATHETER, PERCUTANEOUS1 report
- Launcher LA6SAL10SHCATHETER, PERCUTANEOUS1 report
- Launcher LA6RBU35CATHETER, PERCUTANEOUS1 report
- Launcher LA6AR20SHCATHETER, PERCUTANEOUS1 report
- Launcher LA6AL15CATHETER, PERCUTANEOUS1 report
- Launcher LA63DRCCATHETER, PERCUTANEOUS1 report
- Launcher LA6AR20CATHETER, PERCUTANEOUS1 report
- Launcher LA6FR40CATHETER, PERCUTANEOUS1 report
- Launcher LA6EBU40CATHETER, PERCUTANEOUS1 report
- Launcher LA6ERADRCATHETER, PERCUTANEOUS1 report
- Launcher LA7MAC35CATHETER, PERCUTANEOUS1 report
- Launcher LA7JL35SHCATHETER, PERCUTANEOUS1 report
- Launcher LA7JL35CATHETER, PERCUTANEOUS1 report
- Launcher LA7RDCKCATHETER, PERCUTANEOUS1 report
- Launcher LA7AL75CATHETER, PERCUTANEOUS1 report
- Launcher LA6JR40Catheter, percutaneous1 report
- Launcher LA6EBU30Catheter, percutaneous1 report
- Launcher LA6EBU40SHCatheter, percutaneous1 report
- Launcher LA6JR35Catheter, percutaneous1 report
- Launcher LA6JL35Catheter, percutaneous1 report
- Launcher LA6JL50Catheter, percutaneous1 report
- Launcher LA6SAL10Catheter, percutaneous1 report
- Launcher LA5JR35Catheter, percutaneous1 report
- Launcher LA6AL10Catheter, percutaneous1 report
- Launcher LA6EBU375Catheter, percutaneous1 report
- Launcher LA6JR35Catheter, percutaneous1 report
- LAUNCHER LA6JR35Catheter, percutaneous1 report
- Launcher™ LA6AL20Catheter, percutaneous1 report
- Launcher™ LA7EBU35Catheter, percutaneous1 report
Recent Launcher adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 13, 2026Difficult to Insert; Difficult to Remove; Deformation Due to Compressive Stress; Material Deformation
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE 6F LAUNCHER GUIDE CATHETER, A KINK OCCURRED WHILE IN THE PATIENT APPROXIMATELY 12 INCHES FROM THE HUB AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE LESION BEING TREATED WAS MODERATELY TORTUOUS, MILDLY CALCIFIED WITH 90% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. NO EXCESSIVE FORCE WAS USED AND THE DEVICE WAS NOT EXCESSIVELY TORQUED. IT WAS NOTED TO BE DIFFICULT TO PASS THE WIRE THROUGH THE LAUNCHER GUIDE CATHETER AND A KINK WAS NOTED ON THE X-RAY. IT WAS REPORTED TO BE DIFFICULT TO REMOVE THE LAUNCHER GUIDE CATHETER FOR APPROXIMATELY 5 MINUTES. IT WAS EVENTUALLY POSSIBLE TO ADVANCE THE SHEATH OVER THE KINK TO REMOVE THE CATHETER FROM THE BODY. THERE WAS NO HARM TO THE PATIENT AND IT WAS POSSIBLE TO RESUME THE CASE WITH ANOTHER LAUNCHER GUIDE CATHETER OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24332256 ↗MalfunctionDec 1, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT AN EXPIRED 7F LAUNCHER GUIDING CATHETER WAS USED DURING AN ANGIOPLASTY PROCEDURE. THE DEVICE HAD EXPIRED PRIOR TO THE PROCEDURE, AND THIS WAS DISCOVERED WHEN THE BATCH NUMBER WAS TRACED FOR BILLING PURPOSES. THE CATHETER REMOVED FROM PACKAGING PER INSTRUCTIONS FOR USE WITH NO ISSUES, AND IT WAS PREPPED ACCORDING TO INSTRUCTIONS WITH NO ISSUES. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT, AND NO EXCESSIVE FORCE WAS USED DURING INSERTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23687064 ↗InjuryAug 20, 2025Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT, INSERTION DIFFICULTIES WERE ENCOUNTERED. RESISTANCE WAS NOTED WHEN IT WAS ATTEMPTED TO ADVANCE THE STENT THROUGH THE NON-MEDTRONIC HEMOSTASIS VALVE. THE STENT DELIVERY SYSTEM WAS REMOVED FROM THE GUIDEWIRE FOR INSPECTION. NO ISSUES WERE NOTED AND THE STENT WAS RE-INSERTED WITHOUT ISSUE. THE LESION BEING TREATED WAS MILDLY TORTUOUS AND SEVERELY CALCIFIED LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 95% STENOSIS. THE LESION WAS PRE-DILATED. THE STENT DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED ADVANCING THE STENT. NO EXCESSIVE FORCE WAS USED DURING DELIVERY. THE STENT WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE STENT WAS DELIVERED TO THE LESION WITHOUT RESISTANCE. UPON INFLATING THE STENT BALLOON AT 14ATM, IT WAS NOTED THAT ONLY THE DISTAL ENDS OF THE STENT BALLOON APPEARED TO INFLATE. A LITTLE DOG BONING WAS NOTICED AT THE ENDS OF THE STENT BALLOON. BLOOD CAME BACK INTO THE SYRINGE WHEN NEGATIVE WAS PULLED. IT APPEARED THAT A STENT BALLOON LEAK OCCURRED. THE PHYSICIAN PULLED NEGATIVE AGAIN AND RE-AT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22849038 ↗InjuryAug 6, 2025Difficult to Remove; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation; Material Split, Cut or Torn; Difficult to Remove; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE INVOLVING ONE 7F LAUNCHER GUIDE CATHETER, THE CATHETER KINKED IN THE RADIAL ARTERY WHEN CLOCKING FOR THE PROCEDURE. THE LESION BEING TREATED WAS LOCATED IN THE OSTIAL/PROXIMAL LEFT ANTERIOR DESCENDING (LAD) LESION. THE PATIENT HAD AN INTRA-AORTIC BALLOON PUMP ALREADY IN PLACE RIGHT FEMORAL BUT NO WIRE WAS ADVANCED IN THE CORONARY ARTERY YET. THE PCI WAS ABORTED AFTER THE LAUNCHER GUIDE CATHETER BECAME ENTRAPPED IN THE RIGHT FOREARM DUE TO CATHETER MANIPULATION. ATTEMPTS WERE MADE TO STRAIGHTEN OUT THE CATHETER BUT FAILED DESPITE THE USE OF MULTIPLE WIRES. AN ATTEMPT WAS MADE TO ADVANCE A 7F AND A 8F DILATOR OVER THE GUIDE CATHETER WITHOUT SUCCESS. VASCULAR SURGERY WAS REQUESTED TO ASSIST WITH RETRIEVAL OF THE DEVICE. A RADIAL CUT-DOWN WAS PERFORMED AND REMOVED THE CATHETER IN TWO PIECES. THE RADIAL ARTERY WAS SUTURED. AN ARTERIAL DOPPLER CONFIRMED ROBUST ULNAR ARTERIAL PULSATION. NO FURTHER INTERVENTION WAS PERFORMED. THE LAD PCI WAS COMPLETED THE FOLLOWING DAY. IT WAS BELIEVED THAT THIS EVENT COULD BE DUE TO THE RADIAL ACCESS BEING MORE TORTUROUS AND GUIDE CATHETERS BEING THINNER WALLED THAN OTHER CAT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22725760 ↗MalfunctionJul 15, 2025Positioning Failure; Difficult to Remove; Failure to Advance; Malposition of Device
FROM STAFF: A GUIDE CATHETER KINKED IN THE RADIAL ARTERY WHEN CLOCKING FOR THE PROCEDURE. THIS ULTIMATELY REQUIRED A VASCULAR DOCTOR TO COME AND DO A CUT-DOWN AND LIGATION OF THE RADIAL ARTERY. THIS WAS DURING A PCI [PERCUTANEOUS CORONARY INTERVENTION] ATTEMPT FOR AN OSTIAL LEFT ANTERIOR DESCENDING LESION, ON A PATIENT WITH AN INTRA-AORTIC BALLOON PUMP ALREADY IN PLACE RIGHT FEMORAL. WE HAD NOT YET GOTTEN VERY FAR IN THE ATTEMPT; NO WIRE WAS ADVANCED INTO THE CORONARY ARTERY YET. I THINK THIS EVENT HAPPENED BECAUSE OF RADIAL ACCESS BEING MORE TORTUROUS, GUIDE CATHETERS BEING THINNER WALLED THAN OTHER CATHETERS, POSSIBLE EQUIPMENT FAILURE (GUIDE CATHETER). THIS IS SOMEWHAT UNAVOIDABLE, ALTHOUGH IT COULD BE MITIGATED BY PREFERENTIALLY USING FEMORAL ACCESS IN CASES LIKE THIS, ALTHOUGH THAT WOULD INCREASE THE RISK OF LIFE-THREATENING HEMATOMA OR RETROPERITONEAL BLEED, SO IT MAY NOT BE BENEFICIAL TO PREFER FEMORAL ACCESS. FROM OPERATIVE REPORT: ABORTED PCI ATTEMPT OF PROXIMAL LAD [LEFT ANTERIOR DESCENDING] AFTER GUIDE CATHETER BECAME ENTRAPPED IN THE RIGHT FOREARM DUE TO CATHETER MANIPULATION. ATTEMPTS TO STRAIGHTEN OUT THE CATHETER FAILED DESPITE USE OF MULTIPLE WIRES. WE ALSO TRIED AD
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22505857 ↗InjuryMay 23, 2025Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation; Material Split, Cut or Torn; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE 6F LAUNCHER GUIDE CATHETER, THE DEVICE SNAPPED OFF IN THE PATIENT. THE DEVICE WAS SUBSEQUENTLY RETRIEVED AND REMOVED USING A SNARE. IT WAS NOTED THERE WAS DEFORMATION EVIDENT TO THE DEVICE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 22076455 ↗MalfunctionMay 9, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE SHELF LIFE OF ONE 6F LAUNCHER GUIDE CATHETER WAS EXPIRED NINETEEN DAYS WHEN IT WAS USED. THE DEVICE WAS INSPECTED PRIOR TO USE AND PREPPED PER IFU WITH NO ISSUES NOTED. THE LESION BEING TREATED WAS NON-TORTUOUS, NON-CALCIFIED LOCATED IN THE DISTAL FEMORAL ARTERY. THERE WAS NO PATIENT INJURY OR MEDICAL-SURGICAL INTERVENTIONS AS A RESULT OF THE EVENT. THE PATIENT'S CURRENT HEALTH STATUS IS DESCRIBED AS WELL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21992062 ↗InjuryOct 11, 2024Difficult to Remove; Material Deformation; Material Integrity Problem; Difficult to Remove; Material Deformation; Material Integrity Problem
AN ATTEMPT WAS MADE TO USE ONE 6F LAUNCHER GUIDE CATHETER DURING A PROCEDURE. THERE WERE NO ABNORMALITIES IN THE ANATOMY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. RESISTANCE WAS NOT NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. THERE WAS NO RESISTANCE NOTED WHEN INSERTING THE CATHETER. EXTREME FORCE WAS USED WHEN INSERTING AND DURING ATTEMPTED REMOVAL OF THE CATHETER. THE LAUNCHER WAS INSERTED INTO THE RIGHT FEMORAL ARTERY WITHOUT ANY PROBLEMS. IT WAS REPORTED THAT, IMMEDIATELY AFTER THE LAUNCHER CATHETER WAS BROUGHT INTO THE AORTIC ARCH, WHEN TRYING TO INTUBATE THE LAUNCHER INTO THE OSTIUM, THE LAUNCHER TWISTED OFF AFTER ONLY SLIGHT ROTATION OF THE CATHETER. THE LAUNCHER COULD NOT BE TURNED BACK AND COULD NO LONGER BE INTUBATED WITH THE WIRE. THE LAUNCHER COULD NOT BE MOVED AT ALL, EVEN WITH A LOT OF FORCE AND PULL. THERE WAS A RISK THE LAUNCHER WOULD TEAR OFF. THE ENTIRE LAUNCHER HAD TO BE REMOVED WITH THE SHEATH LYING DOWN. IT WAS POSSIBLE TO RECOVER THE ENTIRE LAUNCHER TOGETHER WITH THE INTRODUCER. THE ISSUE WITH THE LAUNCHER OCCURRED BEFORE INTERVENTION AT THE VESSEL. THE LAUNCHER SEEMED MUCH SOFTER THAN USUAL. THERE WAS NO KINKING NOTED TO THE CATHETER. NEW SHEATHS HA
Patient problems: Insufficient Information
MAUDE report 20426683 ↗InjuryOct 11, 2024Difficult to Remove; Material Deformation; Material Integrity Problem; Difficult to Remove; Material Deformation; Material Integrity Problem
AN ATTEMPT WAS MADE TO USE ONE 6F LAUNCHER GUIDE CATHETER DURING A PROCEDURE. THERE WERE NO ABNORMALITIES IN THE ANATOMY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. RESISTANCE WAS NOT NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. THERE WAS NO RESISTANCE NOTED WHEN INSERTING THE CATHETER. EXTREME FORCE WAS USED WHEN INSERTING AND DURING ATTEMPTED REMOVAL OF THE CATHETER. THE LAUNCHER WAS INSERTED INTO THE RIGHT FEMORAL ARTERY WITHOUT ANY PROBLEMS. IT WAS REPORTED THAT, IMMEDIATELY AFTER THE LAUNCHER CATHETER WAS BROUGHT INTO THE AORTIC ARCH, WHEN TRYING TO INTUBATE THE LAUNCHER INTO THE OSTIUM, THE LAUNCHER TWISTED OFF AFTER ONLY SLIGHT ROTATION OF THE CATHETER. THE LAUNCHER COULD NOT BE TURNED BACK AND COULD NO LONGER BE INTUBATED WITH THE WIRE. IT WAS POSSIBLE TO RECOVER THE LAUNCHER WITH A LOT OF FORCE AND TIME, HOWEVER, THIS RESULTED IN A COMPLETE DESTRUCTION OF THE LAUNCHER. THE DEVICE WAS NO LONGER USABLE. IT WAS POSSIBLE TO RECOVER THE ENTIRE LAUNCHER. THE ISSUE WITH THE LAUNCHER OCCURRED BEFORE INTERVENTION AT THE VESSEL. THE LAUNCHER SEEMED MUCH SOFTER THAN USUAL. THERE WAS NO KINKING NOTED TO THE CATHETER. NEW SHEATHS HAD TO BE CREATED ON THE OTHER SIDE, AND A NEW ME
Patient problems: Insufficient Information
MAUDE report 20426602 ↗InjurySep 3, 2024Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Remove; Deformation Due to Compressive Stress
AN ATTEMPT WAS MADE TO USE ONE 6F LAUNCHER GUIDE CATHETER, DURING A PROCEDURE. IT WAS REPORTED, THAT DURING A HEART CATHETERIZATION, A KINK OCCURRED TO THE SHEATH AND CATHETER. THAT REQUIRED A VASCULAR SURGERY INTERVENTION TO REMOVE THE DEVICE. NO FURTHER INJURY WAS REPORTED ON THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 20123912 ↗MalfunctionJul 5, 2024Leak/Splash; Connection Problem; Leak/Splash; Connection Problem
AN ATTEMPT WAS MADE TO USE ONE 6F LAUNCHER GUIDE CATHETER DURING A PROCEDURE. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ISSUES NOTED. RESISTANCE WAS NOT NOTED WHILE ADVANCING THE DEVICE TO THE LESION. IT WAS REPORTED THAT THE GUIDE CATHETER WAS LEAKING BLOOD DURING USE. THE LEAKING WAS CAUSED BY A CONNECTION PROBLEM, AND THE LAUNCHER COULD NOT BE CONNECTED NORMALLY. IT WAS NOT POSSIBLE TO CONNECT THE NON-MEDTRONIC Y-VALVES. THE LEAK WAS NOTED DURING THE DEVICE AND Y-VALVE CONNECTION, AND THE BLOOD LEAKAGE WAS A RESULT OF THE CONNECTION ISSUES. THE USE OF THE LAUNCHER WAS STOPPED IMMEDIATELY. A NEW CATHETER AND NEW Y-VALVE WERE USED, WHICH WERE CONNECTED AND USED NORMALLY. INTERVENTION WAS NOT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO INJURY TO THE PATIENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19678445 ↗MalfunctionMay 28, 2024Fracture; Material Deformation; Fracture; Material Deformation
AN ATTEMPT WAS MADE TO USE ONE 6F LAUNCHER GUIDE CATHETER DURING A PROCEDURE IN THE RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS NOT PREPPED PER IFU. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. A RADIAL APPROACH WAS USED. IT WAS REPORTED THAT RESISTANCE WAS EXPERIENCED DURING INSERTION OF THE LAUNCHER THROUGH THE SHEATH. THE LAUNCHER WAS REMOVED AND IT WAS NOTED THAT THE WHITE TIP WAS CRACKED. THE PATIENT IS ALIVE WITH NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19404225 ↗InjuryMay 21, 2024Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation
DURING A CORONARY ANGIOGRAM PROCEDURE AN ATTEMPT WAS MADE TO USE ONE 6F LAUNCHER GUIDE CATHETER IN AN ATTEMPT TO ENGAGE THE RIGHT CORONARY ARTERY (RCA). IT WAS REPORTED THAT THE GUIDE CATHETER AND WIRE SLIPPED BACK FROM THE AORTA TO THE PATIENT'S RIGHT FOREARM. ON XRAY THE GUIDE CATHETER COULD BE SEEN TO HAVE A KNOT IN IT AND WAS STUCK IN THE PATIENT, CAUSING PAIN WITH ANY PUSHING AND PULLING. INTERVENTIONAL RADIOLOGY (IR) SERVICE WAS CONTACTED TO COME AND TAKE A LOOK AT THE RETAINED KNOTTED CATHETER. AN ULTRASOUND WAS CARRIED OUT ON THE AFFECTED VESSEL AND BELOW THE CATHETER KNOT SHOWED GOOD ARTERIAL BLOOD FLOW PROXIMAL TO THE KNOT AND COULD SEE THAT THE KNOT WAS TIGHTLY WEDGED INTO PLACE IN THE ARTERY. SURGERY WAS DEEMED NECESSARY AND FEMORAL ACCESS OF THE RIGHT FEMORAL ARTERY WAS OBTAINED TO COMPLETE AN ANGIOGRAM OF THE RIGHT ARM FOR ANATOMICAL IMAGING. THE PATIENT WAS THEN TAKEN OFF THE TABLE AND BROUGHT TO THE OPERATING ROOM (OR) FOR POSSIBLE CUT DOWN AND REMOVAL OF THE RETAINED CATHETER. GRAFT HARVEST TECHNIQUE FROM THE LEG WAS ATTEMPTED, WHICH DID NOT REMAIN PATENT BUT WAS ENSURED THAT ADEQUATE PERFUSION OF THE DISTAL EXTREMITY WAS OBTAINED. THE PATIENT HAS CONTINUED TO HAVE
Patient problems: Insufficient Information; Pain
MAUDE report 19358703 ↗InjuryMay 2, 2024Deformation Due to Compressive Stress; Detachment of Device or Device Component; Deformation Due to Compressive Stress; Detachment of Device or Device Component
THE PATIENT WAS ADMITTED AS AN EMERGENCY WITH A NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (NSTEMI), AND BLOCKAGE OF LEFT CIRCUMFLEX (LCX) ARTERY. AN ATTEMPT WAS MADE TO USE ONE LAUNCHER GUIDE CATHETER DURING A PROCEDURE. AFTER DIAGNOSTIC IMAGING, THE GUIDE CATHETER WAS INTRODUCED VIA A FEMORAL APPROACH, AS THE RADIAL APPROACH WAS NOT POSSIBLE. IT WAS REPORTED THAT A CATHETER DETACHMENT OCCURRED IN VIVO, AND THE CATHETER WAS KINKED. AFTER RELATIVELY SLIGHT TURNING (TORQUING) OF THE CATHETER TO TARGET THE LEFT OSTIUM THERE WAS A SUDDEN LOSS OF RESISTANCE. THE GUIDEWIRE COULD NOT BE PASSED THROUGH AND AFTER FURTHER IMAGING IT SHOWED THAT THE CATHETER WAS DISCONNECTED/SEVERED/SEPARATED AROUND 20CM FROM THE DISTAL END. THE DETACHED PORTION WAS RECOVERED USING A SNARE CATHETER AND A SECOND GUIDEWIRE THROUGH THE SHEATH. WITH AN 8F SHEATH AND USING THE SELDINGER TECHNIQUE IT WAS POSSIBLE TO SUCCESSFULLY FINISH THE ORIGINALLY INTENDED INTERVENTION. A LARGE HEMATOMA DEVELOPED IN THE GROIN REGION AND AN ANEURYSM WHICH HAD DEVELOPED WAS SUTURED THE FOLLOWING DAY. IT WAS ALSO REPORTED ANOTHER CATHETER SHOWED A KINK AT AROUND THE SAME POSITION AT 20CM FROM THE DISTAL END. THE PACKAGE OF THE
Patient problems: Aneurysm; Hematoma; Insufficient Information
MAUDE report 19229315 ↗InjuryApr 26, 2024Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem
AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 70% STENOSIS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE RCA OSTIUM WAS DIFFICULT TO ENGAGE WITH A LAUNCHER GUIDE CATHETER. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE STENT WAS PARTIALLY ADVANCED INTO THE LESION WITH THE ASSISTANCE OF A NON MEDTRONIC GUIDE EXTENSION CATHETER BUT WAS UNABLE TO FULLY PASS THE LESION. THE DEVICE WOULD NOT DELIVER TO THE CALCIFIED PROXIMAL RCA. THE DEVICE WAS THEN STRETCHED AND PULLED OFF THE BALLOON COMING BACK INTO THE GUIDE CATHETER. ON PULLBACK THE STENT WAS NOTED TO HAVE ELONGATED AND PARTIALLY DISLODGED OFF THE BALLOON. EXCESSIVE FORCE WAS NOT DICTATED IN THIS CASE. THE STENT FELL OFF THE SYSTEM FULLY IN THE FOREARM, AND WAS RETRIEVED THROUGH THE SHEATH. THE PROCEDURE WAS THEN FINISHED. A NON-MEDTRONIC STENT WAS USED
Patient problems: Insufficient Information
MAUDE report 19190120 ↗
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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.
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