ViperWireRecalls & reported problems across all models
Cardiovascular Systems, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 214
- Deaths reported
- 10
- Injuries reported
- 195
- Recalls
- 0
We found 2 models of ViperWire by Cardiovascular Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 214 adverse event reports in the FDA's MAUDE database, received between Sep 28, 2015 and Sep 24, 2026 — classified as 10 deaths, 195 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Material Separation” (183 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 ViperWire problems
Device problems
- Material Separation183
- Device Damaged by Another Device24
- Adverse Event Without Identified Device or Use Problem15
- Entrapment of Device14
- Unintended System Motion12
- Detachment of Device or Device Component9
- Improper or Incorrect Procedure or Method8
- Difficult to Advance5
Patient problems
- Foreign Body In Patient145
- Device Embedded In Tissue or Plaque34
- Perforation of Vessels23
- No Clinical Signs, Symptoms or Conditions17
- Vascular Dissection8
- Cardiac Arrest6
- Embolism/Embolus5
- Low Blood Pressure/ Hypotension5
ViperWire models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ViperWire GWC-12325LG-FTCatheter, Coronary, Atherectomy8 deaths157 reports
- ViperWire GWC-12325LG-FLPCatheter, Coronary, Atherectomy2 deaths57 reports
Recent ViperWire adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Material Separation; Improper or Incorrect Procedure or Method
Patient problems: Cardiac Tamponade; Perforation of Vessels
MAUDE report 50890507 ↗InjurySep 2, 2026Material Separation
Patient problems: Foreign Body In Patient
MAUDE report 50573522 ↗InjuryJul 20, 2026Material Separation
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT HEAVILY CALCIFIED, NON-TORTUOUS, 85% STENOSED LESION IN PROXIMAL TO MID CIRCUMFLEX ARTERY (CFX). THE CFX WAS PRIMARILY WIRED WITH A VIPERWIRE ADVANCE CORONARY GUIDE WIRE WITH FLEX TIP WHICH WAS POSITIONED GENEROUSLY DISTAL TO THE LESION. THERE WAS NO WIRE BIAS. THERE WAS NO DIFFICULTY WIRING OR DELIVERING DEVICES. SETUP OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS COMPLETED AND 4 ANTEGRADE, PROXIMAL-TO-DISTAL TREATMENTS WERE SUCCESSFULLY PERFORMED. A NON-ABBOTT GUIDE WIRE WAS ADVANCED AND THE VIPERWIRE WAS REMOVED. AS A PUFF OF CONTRAST WAS MADE THE TIP OF THE VIPERWIRE CAME INTO SIGHT. WITH THE INJECTION THE TIP CAME FROM THE GUIDE WIRE AND LANDED HALFWAY OUT OF THE TIP OF GUIDE WIRE AND HALF INTO THE OSTIUM OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD). EXAMINATION OF THE FRACTURED VIPERWIRE CONFIRMED IT WAS THE SPRING TIP. A SNARE WAS USED TO SUCCESSFULLY EXTRACT THE TIP WHICH REMAINED IN THE SNARE DEVICE. SUCCESSFUL STENT PLACEMENT WAS USED TO COMPLETE THE PROCEDURE. IT WAS NOTED THAT THE OAD TIP BUSHING NEVER CAME ANYWHERE CLOSE TO THE RADIOPAQUE TIP OF THE VIPERWIRE. THERE WERE NO ADVERSE PATIENT EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25874260 ↗InjuryJun 3, 2026Material Separation
IT WAS REPORTED THAT DURING PROCEDURE TO TREAT PROXIMAL LEFT ANTERIOR DESCENDING (LAD) HIGHLY CALCIFIED, NON-TORTUOUS LESION, A NON-ABBOTT WIRE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY THROUGH AN EBU 3.5 GUIDE CATHETER. A 2.5 X 15 SAPPHIRE BALLOON WAS INSERTED OVER NON-ABBOTT WIRE AND INFLATED PROXIMAL. A NON-ABBOTT CATHETER WAS INSERTED OVER THE WIRE AFTER THE BALLOON WAS REMOVED. THE NON-ABBOTT WIRE WAS REMOVED AND VIPERWIRE CORONARY FLEX GUIDEWIRE WAS INSERTED THROUGH THE NON-ABBOTT CATHETER. SEVERAL TREATMENTS RUNS WERE PERFORMED SUCCESSFULLY AT 80,000 RPM. IT APPEARED THAT THE GUIDEWIRE DISTAL TIP WAS SEPARATED FROM THE BODY OF THE WIRE AND LEFT IN THE DISTAL DIAGONAL VESSEL. A NON-ABBOTT CATHETER WAS INSERTED OVER THE VIPERWIRE GUIDEWIRE FLEX TIP AND THEN IT WAS NOTICED THAT THE CATHETER WAS NEXT TO THE VIPERWIRE GUIDEWIRE TIP. AT THIS POINT, THE PHYSICIAN REALIZED THAT THE TIP OF THE WIRE WAS SEPARATED. THE END OF VIPERWIRE CORONARY GUIDEWIRE HAD SHEARED OFF IN DISTAL LAD NEAR APEX AND APPROXIMATELY 30 MM RADIO PLAQUE TIP OF THE GUIDEWIRE WAS LEFT IN-VIVO. A NON-ABBOTT WIRE WAS INSERTED WIRE THOUGH THE NON-ABBOTT CATHETER AND THE PROCEDURE WAS CONTINUED USING A 2.25X18 SKYP
Patient problems: Foreign Body In Patient
MAUDE report 25374158 ↗InjuryMay 8, 2026Material Separation; Device Damaged by Another Device
IT WAS REPORTED A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING USED TO TREAT A FIBROCALCIFIC OBTUSE MARGINAL (OM) 2. IT WAS INDICATED AN UNSPECIFIED BALLOON CROSSED THE LESION BUT DID NOT YIELD TO DILATION. THREE TO FOUR ANTEGRADE TREATMENTS WERE PERFORMED WITH SHORT BACKWARD MOVEMENT TO RE-ADVANCE THE OAD. DURING THE PROCEDURE, THE VIPERWIRE GUIDE WIRE FRACTURED. THERE WAS NO INDICATION AS TO WHAT LED TO THE FRACTURE. THE FRACTURED TIP REMAINED IN-VIVO IN THE FAR DISTAL VESSEL AND WAS NOT RETRIEVED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT WAS IN STABLE CONDITION. THE DATE OF THE PROCEDURE IS AN ESTIMATE.
Patient problems: Foreign Body In Patient
MAUDE report 25126609 ↗DeathApr 24, 2026Difficult to Remove; Material Separation
IT WAS REPORTED A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING USED TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS, 99% STENOSED DISTAL LEFT MAIN (LM)/OSTIAL LEFT CIRCUMFLEX (CX). THE PATIENT WAS GIVEN HEPARIN PRIOR TO ORBITAL ATHERECTOMY, AND AN IMPELLA CP WAS PLACED IN THE PATIENT'S RIGHT FEMORAL ARTERY. A SINGLE ACCESS 7FR SHEATH AND GUIDE SYSTEM WAS UTILIZED. A NON-ABBOTT INTERVENTIONAL WIRE, ALONG WITH A NON-ABBOTT MICROCATHETER, WERE USED TO GET ACROSS THE LESION INITIALLY. THE VIPERWIRE GUIDE WIRE WAS ABLE TO BE EXCHANGED IN. THERE WERE NO APPARENT ISSUES DURING PREPARATION OF THE OAD. THE OAD WAS SUCCESSFULLY LOADED ONTO THE VIPERWIRE, AND ADVANCED JUST PROXIMAL TO THE LESION. A LOW-SPEED TREATMENT WAS PERFORMED FOR FIVE SECONDS, AS THE GUIDE CATHETER WAS PUSHING OUT AND THERE WAS DIFFICULTY REMAINING ENGAGED. IT WAS DETERMINED AT THIS TIME THAT THE PHYSICIAN WAS TO USE GLIDEASSIST MODE TO GET CLOSER TO THE LESION AND HELP SEAT THE GUIDE CATHETER BETTER. GLIDEASISST MODE WAS USED TO GET THE OAD NEXT TO THE LESION BETTER. DURING THIS TIME, THE BRAKE LEVER WAS NOT ENGAGED, AS THEY WERE MOVING THE ENTIRE OAD AT THE TIME. THE BRAKE LEVER WAS LOCKED PRIOR
Patient problems: Cardiac Arrest; Foreign Body In Patient; Perforation of Vessels; Vascular Dissection
MAUDE report 24984313 ↗InjuryApr 20, 2026Material Separation
IT WAS REPORTED THAT RIGHT AND LEFT FEMORAL ACCESS WAS OBTAINED TO PLACE A NON-ABBOTT DEVICE PRIOR TO START OF THE PROCEDURE. HEPARIN WAS USED FOR ANTICOAGULATION AND ACTIVATED CLOTTING TIMES (ACTS) WERE CONFIRMED THERAPEUTIC AND MONITORED. A NON-ABBOTT WIRE WAS PLACED INTO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND EXCHANGED OVER 2.0 OTW BALLOON FOR THE VIPERWIRE CORONARY GUIDEWIRE. A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED WITH A VIPERWIRE CORONARY GUIDEWIRE DURING ATHERECTOMY PROCEDURE TO TREAT 80% STENOSED HEAVILY CALCIFIED CIRCUMFLEX ARTERY. ORBITAL ATHERECTOMY WAS COMPLETED FROM THE LEFT MAIN (LM) TO PROXIMAL LAD SUCCESSFULLY. THE VIPERWIRE GUIDEWIRE WAS REMOVED AND A NON-ABBOTT WIRE WAS ADVANCED INTO THE DISTAL LEFT CIRCUMFLEX. IT WAS THEN EXCHANGED FOR THE VIPERWIRE GUIDEWIRE VIA A TWIN PASS CATHETER. ATHERECTOMY WAS PERFORMED IN THE PROXIMAL CIRCUMFLEX. THE TIP OF THE WIRE WAS SHEARED OFF INTO THE DISTAL LEFT CIRCUMFLEX. 3 CM OF THE WIRE WAS LEFT IN-VIVO. ATTEMPTING TO REWIRE THE LEFT CIRCUMFLEX IN ORDER TO CAPTURE THE WIRE OR STENT IT AGAINST THE WALL WAS DIFFICULT. THE PATIENT EXPERIENCED TACHYCARDIA AND UNSTABLE LEADING TO PULSELESS ELECTRICAL
Patient problems: Cardiac Arrest; Foreign Body In Patient; Perforation of Vessels; Pericardial Effusion; Tachycardia
MAUDE report 24933512 ↗InjuryMar 31, 2026Material Separation; Device Damaged by Another Device
IT WAS REPORTED THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING USED TO TREAT A HEAVILY CALCIFIED RIGHT CORONARY ARTERY (RCA). DURING THE PROCEDURE, THE OAD WAS ADVANCED TOO CLOSE TO THE VIPERWIRE GUIDE WIRE SPRING TIP, WHICH LED TO THE VIPERWIRE FRACTURING. THE FRACTURED COMPONENT WAS ABLE TO BE SNARED. THERE WERE NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24750377 ↗DeathMar 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT HEAVILY CALCIFIED, NON-TORTUOUS, 85% STENOSED PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH DIAMONDBACK 360 PRECISION ORBITAL ATHERECTOMY DEVICE (OAD). THE LESION WAS PRIMARY WIRED WITH VIPERWIRE ADVANCE CORONARY GUIDE WIRE (FLOPPY) THROUGH RIGHT FEMORAL ARTERY ACCESS. FROM ANGIOGRAM IT APPEARED THE VIPERWIRE WAS IN TRUE LUMEN, SITTING IN MID TO DISTAL RCA, STRAIGHT AND NOT IN A BRANCH. NO VESSEL PREPARATION WAS PERFORMED. SEVERAL LOW-SPEED OAD TREATMENTS WERE PERFORMED FOLLOWED BY 2 HIGH-SPEED TREATMENTS. AFTER OAD REMOVAL, ANGIOGRAPHIC IMAGES SHOWED NO REFLOW IN THE TREATED RCA. THE PATIENT BECAME APNEIC (SHORT OF BREATH) AND BLOOD PRESSURE DROPPED TO LOW (HYPOTENSION). CARDIOPULMONARY RESUSCITATION (CPR) AND EMERGENCY MEDICATIONS WERE ADMINISTERED INCLUDING ATROPINE, BUT PATIENT DID NOT RESPOND. ECHO CARDIOGRAM WAS TAKEN BUT NO PERFORATION WAS OBSERVED. THE PATIENT EXPIRED AFTER 45 MINUTES OF UNSUCCESSFUL RESUSCITATION EFFORTS. THE PHYSICIAN THINKS THE PATIENT¿S DISEASE CONTRIBUTED TO THE EVENT AND THERE WAS SOMETHING ELSE GOING ON WITH PATIENT¿S STABILITY AND SICKNESS MAKING THE PATIENT UNABLE TO TOLERATE THE TREATMENT. IN THE OPINION
Patient problems: Cardiac Arrest; Dyspnea; Low Blood Pressure/ Hypotension; Obstruction/Occlusion; Vascular Dissection
MAUDE report 24728563 ↗InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING PROCEDURE TO TREAT 95% STENOSED SEVERELY CALCIFIED TIGHT MID RIGHT CORONARY ARTERY LESIONS WITH MILD TORTUOSITY, A NON-ABBOTT 6F GUIDE WAS USED TO PRIMARILY WIRE THE VESSEL WITH VIPERWIRE ADVANCE CORONARY GUIDEWIRE. THE VESSEL WAS 2.75-3.0MM IN DIAMETER AND 50 MM IN LENGTH. THE VESSEL WAS PREPPED AND A DIAMONDBACK 360 PRECISION CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS ADVANCED JUST PROXIMAL TO THE LESION. WITHIN THE SPECIFIC AREA/LESION THAT WAS BEING TREATED, THERE WERE TWO TIGHTER SPOTS. TWO TREATMENTS WERE PERFORMED WITHOUT ANY JUMP FOR APPROXIMATELY 27 SECONDS ALL THE WAY TO THE END OF THE PLANNED TREATMENT AREA. THE TREATMENT WAS PAUSED 1:1 AND THEN TREATMENT WAS PERFORMED FOR APPROXIMATELY 27 SECONDS. THE TREATMENT WAS RESTED 1:1 AND REPEATED THRICE. THERE WERE PUFFS TAKEN BETWEEN RUNS TO MAKE SURE VESSEL REMAINED OPEN AND THERE WERE NO ISSUES. OCCASIONAL PUFFS OF CONTRAST TAKEN BETWEEN TREATMENTS. AT THE END OF THE LAST TREATMENT, THE PATIENT'S HEART RATE SLOWED. IT WAS NOTED THAT THE PATIENT ALREADY HAD A SLOW HEART RATE, THEREFORE TEMPORARY PACER WAS PLACED AT THE BEGINNING AND PACER SETTING WERE ESTABLISHED AT THE BEGINNING. THE PACER KICK
Patient problems: Ischemia; Non specific EKG/ECG Changes; Obstruction/Occlusion; Vascular Dissection
MAUDE report 24700017 ↗DeathFeb 20, 2026Material Separation
USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES "THE PROCEDURE BEGAN AS A DIAGNOSTIC LEFT HEART CATH. DURING THE ATTEMPTED ORBITAL ATHERECTOMY OF THE CIRCUMFLEX, THE DIAMONDBACK CATHETER WAS UNABLE TO CROSS THE LESION. A SECOND ATTEMPT RESULTED IN THE BURR BECOMING STUCK, AND THE VIPER WIRE APPEARED SHEARED. IMAGING SUGGESTED THE DEVICE HAD BECOME EXTRAVASCULAR WITH SUSPECTED CIRCUMFLEX PERFORATION. OUTCOME ATTRIBUTED TO ADVERSE EVENT: DEATH". THE DATES OF EVENT AND PATIENT EXPIRATION WILL BE ESTIMATED AS (B)(6) 2026.
Patient problems: Foreign Body In Patient
MAUDE report 24401271 ↗InjuryFeb 2, 2026Entrapment of Device; Unintended System Motion; Material Separation; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT A DIAMONDBACK 360 PRECISION CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF A HEAVILY CALCIFIED, NON-TORTUOUS, 90% STENOSED OSTIUM CIRCUMFLEX ARTERY (CFX). THE VESSEL DIAMETER WAS 3.5 MM. THE PATIENT WAS TAKEN TO RECOVERY AND EXPERIENCED CHEST PAIN AND ST DEPRESSIONS. THE PHYSICIAN CONFIRMED THE VIPERWIRE ADVANCE CORONARY GUIDE WIRE WITH FLEX TIP HAD FRACTURED AND THE 3 CM FRACTURED COMPONENT REMAINED IN VIVO. THE PATIENT WAS REFERRED TO SURGERY TO REMOVE THE FRACTURED COMPONENT AND RESOLVE THE PERFORATION. WHILE WAITING FOR SURGERY, THE PATIENT CODED. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED AND HEART PUMP WAS INSERTED. IT WAS APPROXIMATELY A 4-HOUR WAIT UNTIL THE PATIENT WAS TAKEN TO SURGERY. THE FRACTURED COMPONENT WAS SUCCESSFULLY REMOVED AND BYPASS WAS PERFORMED. THE PATIENT WAS STABLE. THE PHYSICIAN REVIEWED THE CASE AND BELIEVED THE WIRE WAS IN AN AREA WHERE TREATMENT WAS NOT PERFORMED [IN DISTAL 2ND OBTUSE MARGINAL ARTERY (OM)]. IT WAS SUSPECTED THE VIPERWIRE MAY HAVE MOVED OUTSIDE OF THE ARTERY AND WHEN THE VIPERWIRE AND GUIDE CATHETER WERE REMOVED, THE VIPERWIRE MAY HAVE BECOME STUCK AND FRACTURED WHICH CAUSED THE PERFORAT
Patient problems: Angina; Cardiac Arrest; Foreign Body In Patient; Ischemia; Perforation of Vessels
MAUDE report 24235814 ↗DeathJan 29, 2026
THE PROCEDURE BEGAN AS A DIAGNOSTIC LEFT HEART CATH. DURING THE ATTEMPTED ORBITAL ATHERECTOMY OF THE CIRCUMFLEX, THE DIAMONDBACK CATHETER WAS UNABLE TO CROSS THE LESION. A SECOND ATTEMPT RESULTED IN THE BURR BECOMING STUCK, AND THE VIPER WIRE APPEARED SHEARED. IMAGING SUGGESTED THE DEVICE HAD BECOME EXTRAVASCULAR WITH SUSPECTED CIRCUMFLEX PERFORATION.
Patient problems: Perforation
MAUDE report 24208206 ↗InjuryDec 12, 2025Material Separation; Material Separation
IT WAS REPORTED THAT DURING ATHERECTOMY PROCEDURE IN A HIGHLY TORTUOUS AND HEAVILY CALCIFIED RIGHT CORONARY ARTERY (RCA), THE VIPERWIRE CORONARY ADVANCE FLEXTIP GUIDEWIRE WAS POSITIONED WELL DISTAL TO THE CROWN, AND THE PROCEDURE WAS BEING PERFORMED SLOWLY WITH THE APPROPRIATE PAUSES. DUE TO THE SEVERE TORTUOSITY AND CALCIFICATION OF THE ARTERY, THE GUIDEWIRE FRACTURED, AND THE RADIOPAQUE TIP DETACHED AND MIGRATED DISTALLY IN THE ARTERY. THREE TREATMENTS WERE PERFORMED PRIOR TO GUIDEWIRE FRACTURE. IN ADDITION, PART OF THE CROWN OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) DETACHED AND MIGRATED INTO THE BLOODSTREAM. THE ENTIRE TIP OF THE OAD FRACTURED. THE PHYSICIAN REMOVED THE SYSTEM FROM THE PATIENT AND REPAIRED THE LESION WITH A STENT. AFTER THE LESION WAS TREATED, AN ATTEMPT WAS MADE TO CAPTURE THE WIRE TIP USING A SNARE, AND LATER BY APPLYING TORQUE WITH ANOTHER WIRE TO TRY TO COIL AND RETRIEVE IT INTO THE CATHETER. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, THE RADIOPAQUE TIP OF THE VIPERWIRE WAS LEFT IN-VIVO TO AVOID ARTERIAL INJURY OR A POTENTIAL PERFORATION THAT COULD OCCUR IF OTHER RETRIEVAL METHODS WERE USED. THE PHYSICIAN LEFT THE RADIOOPAQUE TIP OF THE GUI
Patient problems: Foreign Body In Patient
MAUDE report 23789653 ↗InjuryDec 5, 2025Unintended System Motion; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Unintended System Motion; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT DURING PROCEDURE TO TREAT HEAVILY CALCIFIED, HEAVILY TORTUOUS LESION IN LEFT ANTERIOR DESCENDING ARTERY (LAD) A NON-ABBOTT GUIDE WIRE AND MICROCATHETER WERE USED TO GAIN ACCESS THEN EXCHANGED FOR A VIPERWIRE ADVANCE CORONARY GUIDE WIRE WITH FLEX TIP. WHILE ADVANCING THE DIAMONDBACK 360 PRECISION CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) TO THE LESION ON GLIDEASSIST, THE VIPERWIRE CAME BACK DUE TO THE TORTUOSITY. THERE WAS SIGNIFICANT WIRE BIAS. THERE WAS DIFFICULTY WIRING OR DELIVERING DEVICES. THE OAD AND VIPERWIRE DID NOT MAKE CONTACT. THE VIPERWIRE WAS ACCIDENTALLY PULLED THROUGH THE BACK OF THE OAD. THE PHYSICIAN PROCEEDED TO REMOVE THE VIPERWIRE AND FELT RESISTANCE AT THE OAD DRIVE SHAFT AND THEN STUCK TO THE OAD AND REMOVED IT WHICH RESULTED IN THE DISTAL RADIOPAQUE SPRING TIP FRACTURING. THE FRACTURED COMPONENT WAS SNARED SUCCESSFULLY. THE VIPERWIRE WAS REPLACED TO COMPLETE THE PROCEDURE WITH THE SAME OAD. THERE WERE NO ISSUES REPORTED ON THE OAD GUIDE WIRE BRAKE OR CONTROL KNOB. THERE WAS NO DRIVESHAFT DAMAGE. THE PATIENT WAS STABLE. THE PHYSICIAN HAS NO CONCERNS ABOUT POTENTIAL LONG-TERM RISK OUTCOMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23728758 ↗
Other Cardiovascular Systems, Inc. products
All Cardiovascular Systems, 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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