Turnpike LP catheterRecalls & reported problems across all models
Vascular Solutions, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 34
- Deaths reported
- 1
- Injuries reported
- 17
- Recalls
- 0
We found 2 models of Turnpike LP catheter by Vascular Solutions, Inc. in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between Dec 21, 2016 and Jan 14, 2022 — classified as 1 death, 17 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Detachment Of Device Component” (22 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
Most reported Turnpike LP catheter problems
Device problems
- Detachment Of Device Component22
- Detachment of Device or Device Component5
- Separation Problem5
- Device Dislodged or Dislocated1
- Device Or Device Fragments Location Unknown1
- Material Separation1
Patient problems
- No Known Impact Or Consequence To Patient23
- Vessel Or Plaque, Device Embedded In4
- No Consequences Or Impact To Patient3
- Chest Pain1
- Death1
- Device Embedded In Tissue or Plaque1
- Embolism1
- No Clinical Signs, Symptoms or Conditions1
Turnpike LP catheter models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Turnpike® LP catheter 5639Catheter, Percutaneous1 death19 reports
- Turnpike® LP catheter 5638Catheter, Percutaneous15 reports
Recent Turnpike LP catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 14, 2022Material Separation; Material Separation
AS REPORTED: THE MICROCATHETER WAS USED TO SUPPORT WIRING OF TOTALLY OCCLUDED RCA, BUT IT WAS BROKEN EASILY DESPITE GENTLE USE AND HANDLING". THE MICROCATHETER WAS INTRODUCED UNTIL A CERTAIN POINT AND NO MORE ADVANCEMENT WAS DONE AND IT BROKE, THE WHOLE DEVICE WAS REMOVED WITHOUT ANY SEPARATION. REPORTED THAT NO CONSEQUENCES WERE CAUSED BY THE DEVICE PROBLEM AND NO MEDICAL INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13261708 ↗InjuryApr 16, 2019Separation Problem; Separation Problem
MW5084730 RECEIVED 21MAR2019. NO INITIAL REPORTER INFORMATION WAS DOCUMENTED ON THE MEDWATCH RECEIVED. THE TURNPIKE LP CATHETER WAS BEING USED FOR PCI IN A SEVERELY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY LESION. THE TIP OF THE CATHETER BROKE OFF FROM THE CATHETER. SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO ASPIRATE OUT THE FRAGMENT. THE PATIENT WAS SENT TO THE OPERATING ROOM FOR URGENT CORONARY ARTERY BYPASS GRAFTING.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8520567 ↗MalfunctionMar 7, 2019Separation Problem; Separation Problem
PHYSICIAN WAS UTILIZING A TURNPIKE LP IN A HEAVILY CALCIFIED RCA. AS HE WAS SPINNING THE TURNPIKE LP, HE FELT IT CATCH AND IT WOULD NO LONGER SPIN. HE SPUN IT THE OPPOSITE DIRECTION TO FREE IT AND UPON REMOVAL NOTICED A "FRACTURE" IN THE TIP. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION ON HOW THE TIP WAS RETRIEVED HOWEVER, NO REPLY HAS BEEN RECEIVED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8401193 ↗MalfunctionJan 16, 2019Separation Problem; Separation Problem
DURING A CTO CASE THE HUB CRACKED OFF THE CATHETER. THE TURNPIKE CATHETER WAS USED IN A CTO CASE AND AFTER SOME TIME, THE HUB FATIGUED AND CRACKED OFF THE CATHETER. HAD TO RETRACT IT OUT OF THE BODY AND SWITCHED TO A DIFFERENT CATHETER. NO ADVERSE PATIENT OUTCOMES OR IMPACT WERE NOTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8252577 ↗MalfunctionJan 16, 2019Separation Problem; Separation Problem
PHYSICIAN WAS DOING A RETROGRADE CTO CASE. THE PROXIMAL HUB/TORQUE BOOT BROKE OFF FROM MAIN BODY OF CATHETER. HE WAS ABLE TO REMOVE THE TURNPIKE LP CATHETER FROM THE WIRE AND USED ANOTHER TURNPIKE LP DURING CASE. PHYSICIAN REPORTED HE WAS MEETING A LOT OF RESISTANCE WHILE TORQUEING THE TURNPIKE LP BUT DIDN'T PULL BACK ON CATHETER TO RELIEVE THE TORQUE BUILD UP OR REVERSE THE DIRECTION OF TORQUEING. NO PATIENT IMPACT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8252511 ↗MalfunctionJan 16, 2019Separation Problem; Separation Problem
TURNPIKE LP WAS DEEPLY ADVANCED IN HEAVILY CALCIFIED VESSEL, AND WITH CONTINUED TORQUEING THE HUB SEPARATED AND CAME OFF THE CATHETER. NO PATIENT INJURY OR IMPACT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8252359 ↗InjuryNov 16, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
PHYSICIAN HAD A VERY DIFFICULT RETROGRADE CTO CASE AND USED THE TURNPIKE LP 150 TO ACCESS THE COLLATERAL BRANCHES. WHILE SPINNING THE CATHETER IN BOTH DIRECTIONS, THE HUB OF THE TURNPIKE LP 150 BROKE OFF. SPENT AN HOUR AN A HALF WORKING ON GETTING THE CATHETER OUT WITH OUT LOSING THEIR WIRE PLACEMENT. THE CATHETER CAME OUT, HOWEVER, NOT IN ONE PIECE. PHYSICIAN HAD TO CUT IT TO REMOVE CATHETER W/O LOSING WIRE.
Patient problems: Vessel Or Plaque, Device Embedded In
MAUDE report 8080198 ↗InjuryNov 5, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
A PILOT 200 WIRE WAS USED WITH THE TURNPIKE LP, WHEN THE WIRE WAS REMOVED THROUGH THE TURNPIKE LP IT WAS SHREDDED. ADDITIONAL INFORMATION RECEIVED (B)(6) 2018: AFTER SEVERAL ATTEMPTS THE TURNPIKE LP DID NOT PASS THE LESION, AND THEN IT GOT STUCK IN THE LESION. THE WIRE INSIDE THE TURNPIKE LP WAS ALSO STUCK. PHYSICIAN HAD TO TUG HARD ON THEM BOTH AND THEY BOTH FINALLY CAME OUT TOGETHER. PHYSICIAN NOTICED THE TIP OF THE WIRE WAS SHREDDED, (THE WIRE WAS SHREDDED/UNRAVELED. NO PARTS SEPARATED COMPLETELY) PART OF THE TURNPIKE LP TIP ADHERED ON TO THE WIRE. NO FRAGMENTS WERE LEFT IN THE PATIENT. AFTER REMOVING THE WIRE AND TURNPIKE LP, PHYSICIAN SAID THE LAD AND CIRCUMFLEX ARTERIES 'SHUT DOWN'. THIS RESULTED IN PATIENT CHEST PAIN AND BUMP OF TROPONIN LEVELS IN THE PATIENT. EVENTUALLY PHYSICIAN WAS ABLE TO STABILIZE THE PATIENT WHO IS DOING FINE.
Patient problems: Chest Pain
MAUDE report 8037608 ↗InjuryAug 30, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
THE PHYSICIAN WAS TRYING TO CROSS A HEAVILY CALCIFIED LESION, AND REPORTS THAT THE TIP OF THE CATHETER BROKE OFF. PLANNED STRATEGY WAS TO FIX LAD LESION THEN DO A TAVR. DUE TO THIS INCIDENT PATIENT'S TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WAS DONE THE SAME DAY. DURING THE PROCEDURE IT WAS NOTED THE TIP HAD MIGRATED INTO A SEPTAL BRANCH WHERE IT WAS SPECULATED IT WOULD NOT HARM THE PATIENT. IT WAS NOTED THE TIP MIGRATED TO A SEPTAL BRANCH AND NO FURTHER INTERVENTION WOULD BE REQUIRED. PATIENT WAS BEING DISCHARGED TO HOME ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7832365 ↗InjuryAug 8, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
AS THE CARDIOLOGIST WAS DOING THE PROCEDURE HE CAME ACROSS SEVERE CALCIFICATION PRESENT WITH BIFURCATION AND ATTEMPTED TO PASS WITH SEVERAL BALLOONS AFTER USING A GUIDE AND CROSSING THE LESION WITH A LUGE WIRE VIA THE RADIAL ARTERY, CARDIOLOGIST OBTAINED ACCESS OF THE RIGHT FEMORAL ARTERY AND ABLE TO RE-WIRE WITH 8 FRENCH GUIDE, THE TURNPIKE LP THEN FRACTURED AND PLUGGED THE VESSEL RESULTING IN CESSATION OF FLOW AND COULD NOT REMOVE THE WIRE AS IT WAS FIXED AND ONCE THAT WAS CLEAR DID NOT WANT TO LOSE WIRE POSITION. ST SEGMENTS ELEVATED AND THEN ABLE TO PASS 1.2 MM BALLOON THROUGH THE LESION AND IT PUSHED THE TIP OF THE CATHETER DOWNSTREAM, BALLOON INFLATED AND THE TURNPIKE WAS ADVANCED AND THE ROTA WIRE WAS EXCHANGED. PT DID RECEIVE STENTS. THE PATIENT IS REPORTED AS DOING FINE. PATIENT DISCHARGED TO HOME (B)(6) 2018. INITIAL INFORMATION RECEIVED VIA MEDWATCH 5078186 ON JULY 09, 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7761803 ↗MalfunctionJul 5, 2018Detachment Of Device Component; Detachment Of Device Component
PHYSICIAN WAS USING TURNPIKE IN A SUB-TOTAL OCCLUSION, TRYING TO EXCHANGE THE WIGGLE WIRE FOR A ROTOWIRE. HE TURNED THE CATHETER INTO THE LAD. THERE WAS CALCIUM PRESENT, BUT NOT A FULL CTO. THE TURNPIKE TIGHTENED DOWN ON THE WIGGLE WIRE AND PART OF THE TIP BROKE OFF AND STAYED ON THE WIGGLE WIRE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7663780 ↗MalfunctionJun 14, 2018Detachment Of Device Component; Detachment Of Device Component
HUB OF THE TURNPIKE LP SEPARATED FROM CATHETER DURING TORQUING. PATIENT WAS UNHARMED AS WIRE AND CATHETER WERE REMOVED AND PROCEDURE WAS RESTARTED. A DIFFERENT CATHETER WAS UTILIZED WITHOUT INCIDENT IN WAKE OF SEPARATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7600807 ↗InjuryApr 27, 2018Detachment Of Device Component; Detachment Of Device Component
LAD WAS WIRED ANTEGRADE ON THE SUPPORT OF A MICRO-CATHETER, PHYSICIAN BALLOONED AND STENTED THE VESSEL FROM MID TO PROXIMAL, IN ORDER TO PERFORMED POST DILATION . PHYSICIAN NEEDED TO REINSERT THE MICRO-CATHETER TO EXCHANGE THE WIRE. THE TIP OF THE TURNPIKE GOT DISLODGED, AND STUCK IN THE MID LAD AND SUBSTANTIAL EFFORTS WERE NEEDED TO REMOVE IT. GUIDELINER, ADDITIONAL WIRE, REPEAT BALLOONING. FINAL POST DILATION PERFORMED AT THE END WITH A SHORT LARGER BALLOON. THE DISTAL GRAFT ANASTOMOTIC SEGMENT WAS LEFT UNTOUCHED. GOOD FLOW POST PROCEDURE. WELL TOLERATED OVERALL. LEFT FEMORAL ACCESS CLOSED. DILATION OF THE LAD. LAD HAD ATHEROSCLEROSIS, CORONARY ARTERY CALCIFICATION. NO PATIENT COMPLICATIONS OR INJURY REPORTED. CURRENT CONDITION OF PATIENT IS REPORTED AS "FINE".
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7468974 ↗InjuryApr 13, 2018Detachment Of Device Component; Detachment Of Device Component
THE TIP OF THE TURNPIKE LP DID BREAK LOOSE IN THE LAO. DR. DID CAPTURE THE TIP OF THE TURNPIKE WITH THE WIRE. REPORTED THE LOA HAD ATHEROSCLEROSIS IN THE LOA ARTERY WITH (CAC) CORONARY ARTERY CALCIFICATION. REPORTED THAT THERE WAS NO PATIENT INJURY OR CONSEQUENCE, PATIENT CURRENT CONDITION IS FINE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7430410 ↗InjuryMar 5, 2018Detachment Of Device Component; Detachment Of Device Component
PHYSICIAN WAS USING TURNPIKE TO ASSIST IN WIRING THE OBTUSE MARGINAL VESSEL. WHILE ATTEMPTING THIS MULTIPLE TIMES THE TIP OF THE TURNPIKE LP BROKE OFF INSIDE THE VESSEL. PHYSICIAN ATTEMPTED TO WIRE THE VESSEL AFTER THIS HAPPENED SO AS TO RETRIEVE THE TIP, BUT W/O SUCCESS. HE WAS QUOTED BY THE STAFF AS SAYING "HE DIDN'T NEED TO RETRIEVE THE TIP BECAUSE THE VESSEL WAS SHUT DOWN AND IT WOULDN'T MIGRATE ANY FURTHER". THE PATIENT WAS ALERT AND ORIENTED AFTER DEPARTING THE CATH LAB AND NO ISSUES SINCE. NO PATIENT IMPACT OR INJURY WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7313433 ↗
Other Vascular Solutions, Inc. products
All Vascular Solutions, Inc. devices →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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