Diamondback PeripheralRecalls & reported problems across all models
Cardiovascular Systems, Inc. · 33 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 346
- Deaths reported
- 1
- Injuries reported
- 251
- Recalls
- 0
We found 33 models of Diamondback Peripheral by Cardiovascular Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 346 adverse event reports in the FDA's MAUDE database, received between Sep 17, 2015 and Sep 11, 2026 — classified as 1 death, 251 injuries, 94 malfunctions.
The most frequently reported specific device problem is “Entrapment of Device” (145 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 Diamondback Peripheral problems
Device problems
- Entrapment of Device145
- Adverse Event Without Identified Device or Use Problem67
- Material Separation63
- Difficult to Remove20
- Unexpected Shutdown19
- Unintended System Motion11
- Mechanical Problem10
- Device Contaminated at the User Facility8
Patient problems
- Perforation of Vessels48
- Vascular Dissection45
- Foreign Body In Patient43
- No Clinical Signs, Symptoms or Conditions42
- Device Embedded In Tissue or Plaque40
- No Consequences Or Impact To Patient33
- No Known Impact Or Consequence To Patient29
- Vessel Or Plaque, Device Embedded In26
Diamondback Peripheral models
33 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Diamondback Peripheral DBP-125MICRO145Catheter, Peripheral, Atherectomy82 reports
- Diamondback Peripheral DBP-125MICRO145Catheter, Peripheral, Atherectomy35 reports
- Diamondback Peripheral DBP-200SOLID145Catheter, Peripheral, Atherectomy30 reports
- Diamondback Peripheral DBP-125SOLID145Catheter, Peripheral, Atherectomy29 reports
- Diamondback Peripheral DBP-125SOLID145Catheter, Peripheral, Atherectomy22 reports
- Diamondback Peripheral DBP–200SOLID145Catheter, Peripheral, Atherectomy1 death18 reports
- Diamondback Peripheral DBP-EX-125MIC145Catheter, Peripheral, Atherectomy18 reports
- Diamondback Peripheral DBP-150SOLID145Catheter, Peripheral, Atherectomy16 reports
- Diamondback Peripheral DBP-150SOLID145Catheter, Peripheral, Atherectomy13 reports
- Diamondback Peripheral DBP-EX-125SOL145Catheter, Peripheral, Atherectomy10 reports
- Diamondback Peripheral DBP-EX-200SOL145Catheter, Peripheral, Atherectomy10 reports
- Diamondback Peripheral DBP-125MICRO145Catheter, Peripheral, Atherectomy9 reports
- Diamondback Peripheral DBP–150CLASS145Catheter, Peripheral, Atherectomy9 reports
- Diamondback Peripheral DBP-125MICRO60Catheter, Peripheral, Atherectomy6 reports
- Diamondback Peripheral DBP–200CLASS145Catheter, Peripheral, Atherectomy6 reports
- Diamondback Peripheral DBP-150CLASS145Catheter, Peripheral, Atherectomy5 reports
- Diamondback Peripheral DBP-EX-150SOL145Catheter, Peripheral, Atherectomy5 reports
- Diamondback Peripheral DBP-150SOLID200Catheter, Peripheral, Atherectomy3 reports
- Diamondback Peripheral DBP-200CLASS145Catheter, Peripheral, Atherectomy2 reports
- Diamondback Peripheral DBP-150SOLID200Catheter, Peripheral, Atherectomy2 reports
- Diamondback Peripheral DBP-EX-150CLA145Catheter, Peripheral, Atherectomy2 reports
- Diamondback Peripheral DBP-EX-200CLA145Catheter, Peripheral, Atherectomy2 reports
- Diamondback Peripheral DBP-CART-125MIC145Catheter, Peripheral, Atherectomy2 reports
- Diamondback Peripheral DBP-CART-150CLA145Catheter, Peripheral, Atherectomy1 report
- Diamondback Peripheral DBP-CART-200CLA145Catheter, Peripheral, Atherectomy1 report
- Diamondback Peripheral DBP-EX-HANDLECatheter, Peripheral, Atherectomy1 report
- Diamondback Peripheral DBP-125SOLID200Catheter, Peripheral, Atherectomy1 report
- Diamondback Peripheral DBP-175SOLID180Catheter, Peripheral, Atherectomy1 report
- Diamondback Peripheral DBP-125SOLID200Catheter, Peripheral, Atherectomy1 report
- Diamondback Peripheral DBP-175SOLID180Catheter, Peripheral, Atherectomy1 report
- Diamondback Peripheral DBP-EX-125SOL200Catheter, Peripheral, Atherectomy1 report
- Diamondback Peripheral DBP-EX-175SOL180Catheter, Peripheral, Atherectomy1 report
- Diamondback Peripheral DBP-CART-125SOL200Catheter, Peripheral, Atherectomy1 report
Recent Diamondback Peripheral adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 11, 2026Noise, Audible; Device Contaminated at the User Facility
It was reported that a Diamondback 2.0 solid Peripheral Orbital Atherectomy Device (OAD) was used in moderately calcified and mildly tortuous left superficial femoral artery (SFA) chronic total occlusion (CTO) and during treatment the physician noticed an audible difference and stopped the use of OAD. Two treatments were performed with the OAD before the reported issue was observed. There were no observed device issues noticed before the audible sound. The noise heard was low pitch. During removal, it was noticed intima was wrapped around the crown under live x-ray. The cause of embolism was while removing it through the sheath, the tissue/intima came off the crown and went downstream. After OAD removal, the physician used a non-Abbott device to perform thrombectomy to remove a piece of intima that had traveled downstream in the posterior tibial. Patient had no other complications or symptoms after removal. The patient was stable.
Patient problems: Device Embedded In Tissue or Plaque; Embolism/Embolus
MAUDE report 50734561 ↗InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem
It was reported that target vessel was heavily calcified superficial femoral artery (SFA) to popliteal to tibial peroneal trunk(TPT) to posterior tibial (PT) to pedal loop. The lesion was greater than 70% throughout each artery, approximately 450 cm in total disease length treated. The physician was able to easily navigate an 0.014 through the calcified disease and around the pedal loop with an 0.014 non-Abbott guidewire. It was then swapped for an 0.014 Viperwire Peripheral guidewire. Atherectomy was performed up to medium speed using a A Diamondback 360 Peripheral Exchange Orbital Atherectomy Device (OAD) in popliteal-TPT-PT. Then the cartridge on the Exchangeable device was swapped for a micro crown which was used to perform atherectomy in the pedal loop. It was noted flushing was performed between each run and 30 seconds of treatment to rest was also followed. ACT was drawn and within normal range for intervention. Embolization of the distal vessels in the patient¿s foot occurred as a result of orbital atherectomy system. Angioplasty was performed using balloons of varying sizes and it was noted that flow had been lost in the PT and down the pedal loop. It was a case of persist
Patient problems: Embolism/Embolus; Obstruction/Occlusion; Thrombosis/Thrombus
MAUDE report 50459610 ↗InjuryJul 27, 2026Unexpected Shutdown
It was reported that during procedure to treat right superficial femoral artery (SFA) using a Diamondback 360 Peripheral Orbital Atherectomy Device (OAD), after several treatments on low and medium speed, the device shut down due to what was believed to be dissection. The physician ensured the Viperwire guidewire and OAD handle were all straight, and ran the device again but the same issue occurred. It was noted that there might be a dissection the crown was getting caught in. The device was removed from the body. There was no dissection noted prior to using OAD. Type A dissection was observed when the picture was taken after the OAD was removed, and percutaneous transluminal angioplasty (PTA) was done. The procedure was completed using non-Abbott intravascular lithotripsy (IVL), PTA, and use of non-Abbott stents to treat dissection. The patient was stable.
Patient problems: Vascular Dissection
MAUDE report 50039229 ↗InjuryJun 1, 2026Entrapment of Device; Difficult to Remove
IT WAS REPORTED A DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING USED TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS, 100% STENOSED RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. IT WAS INDICATED THE OAD AND VIPERWIRE WERE STUCK TOGETHER, AND THE OAD WAS STUCK IN THE VESSEL. THE PHYSICIAN WAS UNABLE TO REMOVE THE OAD AND VIPERWIRE FROM EACH OTHER. THIS OCCURRED AFTER ORBITAL ATHERECTOMY TREATMENT WAS COMPLETE AND THE DEVICES WERE ATTEMPTED TO BE REMOVED. A NON-ABBOTT GUIDE WIRE AND A NON-ABBOTT BALLOON WERE INSERTED TO ASSIST WITH DISLODGING THE OAD FROM THE VESSEL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PROCEDURE WAS CONSIDERED SUCCESSFUL.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 25350491 ↗InjuryMar 30, 2026Entrapment of Device; Unintended System Motion; Difficult to Remove; Device Contaminated at the User Facility
IT WAS REPORTED THAT DURING PROCEDURE TO TREAT 100% STENOSED, HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA), A VIPERWIRE PERIPHERAL GUIDEWIRE WAS PASSED THROUGH A LONG CHRONIC TOTAL OCCLUDED (CTO) SEGMENT OF SFA FROM PEDAL ACCESS AND BROUGHT THROUGH FEMORAL DESTINATION SHEATH. THERE WAS NO EVIDENCE OF SUBINTIMAL WIRE PLACEMENT THAT WAS NOTED. INTRAVASCULAR ULTRASOUND (IVUS) WAS NOT PERFORMED. THE CROWN OF DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS ADVANCED TO PROXIMAL SFA AND THE OAD WAS SPUN SLOWLY ON LOW SPEED WORKING THROUGH THE CTO OF SFA. THE OAD CROWN MADE NO NOISE INDICATING THE CROWN WAS SPINNING THROUGH A DISSECTION PLANE. IT JUMPED FORWARD ONE TIME AND TREATMENT WAS STOPPED. THE OAD CROWN WAS RETRACTED. IT WAS PLANNED TO TREAT A BIT MORE SECTION OF THE SFA. THE CROWN SEEMED TO BE STUCK UPON REMOVAL. A 0.14 WIRE WAS INSERTED AND A BALLOON WAS PLACED AROUND THE CROWN. NITRO WAS ADMINISTERED THROUGH THE OAD IN AN ATTEMPT TO RELIEVE THE CROWN FORM BEING STUCK. NOTHING WAS SUCCESSFUL AND THEREFORE, A 0.35 WIRE WAS PLACED DOWN THE NON-ABBOTT SHEATH. THE NON-ABBOTT SHEATH AND CROWN WERE REMOVED. TISSUE WAS NOTED TO BE WRAPPED AROUND THE CROWN. A NEW NON
Patient problems: No Clinical Signs, Symptoms or Conditions; Pain
MAUDE report 24709281 ↗InjuryMar 24, 2026Difficult to Remove; Unexpected Shutdown
IT WAS REPORTED THAT THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING USED FOR TREATMENT OF THE LEFT PERONEAL ARTERY (PT) THROUGH COMMON FEMORAL ARTERY (CFA) ACCESS. WHILE SPINNING, THE OAD MADE AN AUDIBLE SOUND (BOGGED DOWN) AND COULD NOT BE RETRACTED OVER THE VIPERWIRE ADVANCE GUIDE WIRE; IT SEEMED THE OAD/CROWN WAS STUCK ON THE VIPERWIRE. IT WAS UNKNOWN IF THE OAD LED LIGHTS WERE LIT WHEN THE OAD STALLED. EVERYTHING HAD TO BE PULLED OUT. EX VIVO THERE WAS NO PHYSICAL DAMAGE OBSERVED ON THE OAD DRIVESHAFT OR VIPERWIRE. THE PHYSICIAN ATTEMPTED TO REWIRE THE PERONEAL ARTERY TO TREAT THE DISSECTION UNSUCCESSFULLY - THE LESION WAS IN ANTERIOR TIBIAL ARTERY. THERE WAS NO FLOW WHEN AN IMAGE WAS OBTAINED IN PERONEAL ARTERY WHEN THE OAD AND VIPERWIRE WERE REMOVED. DURING FINAL ANGIOGRAM, SOME FLOW WAS NOTED IN PERONEAL ARTERY BUT WAS NOT COMPLETE TO THE FOOT. THE PROCEDURE WAS COMPLETED WITH INTRAVASCULAR LITHOTRIPSY (IVL) AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE PATIENT WAS STABLE. IT WAS BELIEVED THE OAD STALLED IN A DISSECTION AREA IN PERONEAL ARTERY, HOWEVER, THIS WAS NOT CONFIRMED.
Patient problems: Obstruction/Occlusion; Vascular Dissection
MAUDE report 24682245 ↗InjuryMar 24, 2026Entrapment of Device; Improper or Incorrect Procedure or Method
IT WAS REPORTED A DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING USED IN AN ATTEMPT TO TREAT HEAVILY CALCIFIED, MODERATELY TORTUOUS, 100% STENOSED POSTERIOR TIBIAL ARTERY (PTA). GLIDEASSIST MODE WAS USED IN AN ATTEMPT TO CROSS THROUGH THE PEDAL ARCH TO TREAT THE PTA, HOWEVER, THE OAD BECAME STUCK IN THE PEDAL ARCH. MULTIPLE ATTEMPTS WERE MADE TO DISLODGE THE OAD. ALL ATTEMPTS WERE UNSUCCESSFUL. OPEN ENDARTECTOMY OF THE DORSALIS PEDIA WAS PERFORMED TO FREE THE OAD. THE PATIENT WAS IN STABLE CONDITION WITH PATENT DORSALIS PEDIS. IT WAS INDICATED THE VESSEL WAS TOO SMALL FOR THE OAD AND A VASOSPASM OCCURRED, WHICH LED TO THE OAD BECOMING STUCK.
Patient problems: Device Embedded In Tissue or Plaque; Vasoconstriction
MAUDE report 24682157 ↗InjuryMar 18, 2026Entrapment of Device
IT WAS REPORTED THAT DURING PROCEDURE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) GOT STUCK IN HEAVILY CALCIFIED DISTAL RIGHT ANTERIOR TIBIAL VESSEL. THE VESSEL DIAMETER WAS 2.0-2.5 MM. AN ATTEMPT TO ENGAGE GLIDEASSIST WAS MADE, BUT DID NOT WORK. LUMINAL AND PLAQUE MORPHOLOGY WAS VERIFIED BY INTRAVENOUS ULTRASOUND. THE VESSEL WAS PREDILATED WITH A 1.5 MM JADE BALLOON AND THE PATIENT WAS SENT TO EMERGENCY ROOM. THE DEVICE WAS REMOVED DURING SURGERY. BYPASS WAS PERFORMED TO THE PERONEAL ARTERY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24627528 ↗MalfunctionMar 2, 2026Difficult to Remove
IT WAS REPORTED THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) DID NOT FUNCTION PROPERLY AND GOT STUCK ON THE VIPERWIRE GUIDE WIRE DURING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24484935 ↗InjuryDec 8, 2025Entrapment of Device; Unexpected Shutdown; Device Contaminated at the User Facility; Entrapment of Device; Unexpected Shutdown; Device Contaminated at the User Facility
IT WAS REPORTED THAT DURING PROCEDURE TO TREAT LESION IN CALCIFIED, HIGHLY TORTUOUS, 85% STENOSED DISTAL DORSALIS PEDIS ARTERY (DP), THE 1.25 MICRO DIAMONDBACK 360 EXCHANGEABLE PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) SHUT OFF DURING FIRST RUN. THE VESSEL DIAMETER WAS 2.00MM. THE VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE WITH FLEX TIP WAS EXCHANGED FROM A NON-ABBOTT WIRE. DURING REMOVAL, IT WAS NOTED THAT THE OAD BECAME ENTANGLED IN THE DISSECTION FLAP. THERE WAS NO DISSECTION BEFORE THE PROCEDURE. THE DISSECTION WAS NOT SEEN ANGIOGRAPHICALLY BUT THE PHYSICIAN THOUGHT IT WAS A SMALL FLAP THAT THE CROWN GOT STUCK ON. THE OAD AND THE VIPERWIRE COULD NOT BE REMOVED DUE TO THE VIPERWIRE BEING FRACTURED AND STUCK IN THE VESSEL. A CUT DOWN PROCEDURE WAS PERFORMED FOR REMOVAL, AND THE PHYSICIAN WAS ABLE TO REMOVE THE CROWN, BUT THE ENTIRE RADIOPAQUE SECTION OF THE VIPERWIRE TIP WAS LEFT IN THE LEG AS THERE WAS NO LONGER ACCESS TO THE VESSEL. WIRE ACCESS WAS LOST DUE TO THE VIPERWIRE BEING STUCK IN THE VESSEL DISTAL TO THE CROWN THAT WAS STUCK IN THE VESSEL WALL. THE VIPERWIRE RADIOPAQUE TIP WAS LEFT IN THE FOOT AND THE CUT DOWN TO REMOVE THE CROWN WAS SUTURED CLOSED. THE DISSECTION WAS N
Patient problems: Vascular Dissection
MAUDE report 23749708 ↗InjuryNov 4, 2025Entrapment of Device; Entrapment of Device
IT WAS REPORTED THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) CROWN GOT STUCK. A CUTDOWN OF THE OAD WAS PERFORMED WITH A SHEATH AND CATHETER BEING INSERTED IN AN ATTEMPT TO RETRIEVE THE STUCK DEVICE, HOWEVER, THIS WAS UNSUCCESSFUL. EVENTUALLY A VASCULAR SURGEON RECOMMENDED TO PULL EXTREMELY HARD ON THE DEVICE WHICH ENDED UP RESOLVING THE ISSUE. BALLOON ANGIOPLASTY WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23467088 ↗MalfunctionOct 23, 2025Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED THAT DURING PERIPHERAL INTERVENTION OF THE LEFT LEG VIA RIGHT FEMORAL ARTERY & LEFT POSTERIOR TIBIAL (PT) PEDAL ACCESS, A VIPERWIRE PERIPHERAL GUIDEWIRE WAS ADVANCED DOWN INTO THE DISTAL PERONEAL ARTERY. THE 1.25 SOLID DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS PLACED OVER THE VIPERWIRE GUIDEWIRE TO TREAT THE TIBIOPERONEAL (TP) TRUNK AND DOWN TO ABOUT THE MID-PERONEAL. AT SOME POINT BETWEEN CHECKING THE VIPERWIRE GUIDEWIRE TIP PLACEMENT AND THEN ACTUALLY STARTING THE TREATMENT, THE GUIDEWIRE WAS PULLED BACK AND THEN ADVANCED DEEP INTO A COLLATERAL. DURING FIRST TREATMENT, A SLACK IN THE VIPERWIRE GUIDEWIRE WAS NOTICED ON THE FLOUROSCOPY MONITOR. THE GUIDEWIRE FRACTURED AND THE OAD AUTOMATICALLY SHUT OFF. THE OAD WAS REMOVED, TWO GUIDEWIRE FRAGMENTS LEFT IN-VIVO. THE MAJORITY OF THE TIP OF THE VIPERWIRE GUIDEWIRE SPRING TIP WAS LODGED DEEP INTO A COLLATERAL OFF OF THE PERONEAL. A SMALL PIECE OF WIRE FRAGMENT WAS AT THE DISTAL TO THE TAKEOFF OF THE PERONEAL. MULTIPLE SNARES WERE USED TO TRY AND REMOVE THE FRAGMENTS BUT WERE UNSUCCESSFUL. AT THIS POINT IT WAS NOTICED THAT THE SMALL PROXIMAL FRAGMENT PIECE WAS MOSTLY OCCLUSIVE AND THERE WAS NO FLOW IN E
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23369859 ↗InjurySep 18, 2025Entrapment of Device; Device Contaminated at the User Facility; Entrapment of Device; Device Contaminated at the User Facility
IT WAS REPORTED THAT DURING PROCEDURE TO TREAT HIGHLY CALCIFIED, CHRONIC TOTALLY OCCLUDED PERONEAL ARTERY THROUGH FEMORAL ARTERY ACCESS, THE CROWN OF THE 1.25MM MICRO DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) BECAME STUCK IN THE VESSEL DUE TO CALCIFICATION. THE REFERENCE VESSEL DIAMETER WAS 2.5MM. THE VIPERWIRE ADVANCE GUIDE WIRE WAS MOVING FREELY BUT THE CROWN SEEMED WRAPPED/STUCK IN CALCIUM. OAD REMOVAL ATTEMPTS INCLUDING USE OF GLIDEASSIST, USE OF BUDDY WIRE WITH BALLOON TO ATTEMPT CROWN DISLODGEMENT, EXTERNAL CALF MASSAGE TO LOOSEN OAD, AND NITROGLYCERIN/VASODILATORS ADMINISTRATION WERE UNSUCCESSFUL. SURGERY WAS PERFORMED TO COMPLETELY REMOVE THE OAD. THE OAD WAS OBSERVED TO HAVE PLAQUE AND CALCIUM UPON REMOVAL. THE SURGERY WAS COMPLETELY SUCCESSFUL. THE PATIENT WAS STABLE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23088732 ↗InjurySep 11, 2025Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT AFTER THE USE OF DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD), DURING REMOVAL OF THE OAD OVER VIPERWIRE GUIDEWIRE, THE GUIDEWIRE BECAME STUCK IN THE DEVICE. THE OAD AND GUIDEWIRE WERE REMOVED TOGETHER, CAUSING A DELAY IN THE PROCEDURE DUE TO THE PHYSICIAN NEEDING TO ATTEMPT TO CROSS THE LESION AGAIN WITH A NEW WIRE, WHICH WAS UNSUCCESSFUL. DUE TO NOT BEING ABLE TO RE-CROSS THE LESION, THE PROCEDURE WAS ABORTED WITHOUT FULLY TREATING THE PATIENT. IT IS UNKNOWN HOW MANY TREATMENTS WERE PERFORMED PRIOR TO OAD REMOVAL. ACCORDING TO THE PHYSICIAN, THE DELAY IN PROCEDURE WAS CONSIDERED TO BE CLINICALLY SIGNIFICANT TO THE PATIENT DUE TO THE GUIDEWIRE BEING REMOVED AND THE INABILITY TO CROSS THE LESION AGAIN WITH ANOTHER WIRE AS THIS LED TO THE PROCEDURE NOT BEING COMPLETED, LEAVING A SIGNIFICANT BLOCKAGE. IN THE OPINION OF THE PHYSICIAN, THE ABORTED PROCEDURE CONSIDERED TO BE CLINICALLY SIGNIFICANT TO THE PATIENT AS THE BLOCKAGE WAS NOT FULLY TREATED RESULTING IN NEED FOR A SECOND PROCEDURE ON THE PATIENT THAT WOULD NOT HAVE BEEN NECESSARY HAD THE WIRE NOT BEEN REMOVED. THE PATIENT HAS A FOLLOW-UP PROCEDURE PLANNED AND WAS STABLE. ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23031027 ↗MalfunctionJul 25, 2025Break; Fluid/Blood Leak; Air/Gas in Device; Break; Fluid/Blood Leak; Air/Gas in Device
IT WAS REPORTED THAT DURING SETUP THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) AND SALINE LINE WERE TAKEN OUT OF THE PACKAGING AND CONNECTED TO PUMP. THE OAD WAS NOT CONNECTED TO PATIENT OR VIPERWIRE ADVANCE GUIDE WIRE. THE GREEN START BUTTON ON THE PUMP WAS PRESSED TO START SALINE FLOW THROUGH THE SALINE TUBING. THE GREEN LED LIGHT WAS LIT. THE PRIME BUTTON ON THE PUMP WAS THEN PRESSED TO PURGE AIR FROM THE SALINE TUBING BUT BUBBLES WERE OBSERVED INSIDE THE TUBING. CLOSER EXAMINATION OF TUBING REVEALED FLUID LEAK FROM PINHOLE LOCATED BETWEEN A SALINE TUBING POSITIONER AND THE SALINE BAG SPIKE. THE OAD AND SALINE TUBING WERE BOTH REPLACED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE IS NO INDICATION AS TO WHAT CAUSED THE PINHOLE AS THERE WAS NO DAMAGE TO THE OAD PACKAGING OR TRAY INDICATING THE DAMAGE OCCURRED DURING TRANSIT OR HANDLING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22609956 ↗
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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