Diamondback CoronaryRecalls & reported problems across all models

We found 7 models of Diamondback Coronary by Cardiovascular Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 616 adverse event reports in the FDA's MAUDE database, received between Aug 20, 2015 and Sep 21, 2026 — classified as 123 deaths, 419 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Material Separation” (118 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 Diamondback Coronary problems

Diamondback Coronary models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Diamondback Coronary DBEC-125

  Catheter, Coronary, Atherectomy
  43 deaths173 reports
• Diamondback Coronary DBEC-125

  Catheter, Coronary, Atherectomy
  30 deaths162 reports
• Diamondback Coronary DBEC-125

  Catheter, Coronary, Atherectomy
  21 deaths127 reports
• Diamondback Coronary DBEC-125

  Catheter, Coronary, Atherectomy
  11 deaths85 reports
• Diamondback Coronary DBEC-125

  Catheter, Coronary, Atherectomy
  18 deaths60 reports
• Diamondback Coronary DBEC-125M

  Catheter, Coronary, Atherectomy
  8 reports
• Diamondback Coronary SIP-3000

  Catheter, Coronary, Atherectomy
  1 report

Recent Diamondback Coronary adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Entrapment of Device

  It was reported a Diamondback 360 Coronary Orbital Atherectomy System (OAS) was stuck in a heavily calcified, heavily tortuous right coronary artery (RCA). This resulted in a small perforation. The vessel was attempted to be wired for a balloon to be inserted in an attempt to free the device, however, this was aborted and the OAD was able to be removed from the patient without intervention. The perforation was treated with balloon tamponade with two long inflations.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation of Vessels

  MAUDE report 50838133 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Perforation of Vessels

  MAUDE report 50573555 ↗
• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the procedure was to treat a de novo, heavily calcified, moderately tortuous left anterior descending (LAD) artery lesion with 98% stenosis. The vessel was ballooned and a 1.25mm Diamondback coronary orbital atherectomy device was used. Both a 3x28 mm Xience Skypoint drug-eluting stent (DES) and a 3.25x18 mm Xience Skypoint DES were implanted without issue. A non-Abbott guide wire caused the LAD to dissect and shut down flow distal to the stent edge. The circumflex (CX) artery also shut down. Angios performed before and after the procedure confirmed the circumflex was no longer open and likely clotted with persistent no flow. It was noted that the non-Abbott wire had lost position. When the wire lost position, the physician was able to get the guide back in left main artery and took a picture that confirmed dissection. The dissection was distal to the stent and spiraled down the LAD. Dissection and shut down of CX were not treated. The physician attempted to use a balloon pump and performed chest compressions shocking the patient. The patient later died due to dissection. The physician was not sure about what caused the CX to shut down but believed the non-Abbo

  Patient problems: Obstruction/Occlusion

  MAUDE report 50409067 ↗
• InjuryAug 3, 2026Entrapment of Device

  It was reported that a Diamondback 360 Coronary Orbital Atherectomy Device (OAD) was used to treat the left main and circumflex arteries. Upon removal, the crown became stuck in the vessel. A secondary wire and balloon were used to free the crown from the vessel. There was no clinically significant delay to the procedure and no patient adverse effects. There is no additional information.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50122270 ↗
• MalfunctionJul 31, 2026Fluid/Blood Leak; Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50101639 ↗
• MalfunctionJul 1, 2026Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN ATTEMPTED TO USE A 1.5 ROTATIONAL ATHERECTOMY DEVICE BUT IT STALLED AND GOT STUCK IMMEDIATELY. A DIAMONDBACK 360 PRECISION CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS THEN INSERTED AND 4 PROXIMAL-TO-DISTAL TREATMENTS WERE PERFORMED ON LOW SPEED. WHILE REMOVING THE OAD FROM THE BODY, IT WAS NOTICED THAT THE DRIVESHAFT WAS FRACTURED AT THE CROWN. THE OAD AND THE VIPERWIRE ADVANCE CORONARY GUIDE WIRE WERE REMOVED AS A SYSTEM. THE VESSEL WAS REWIRED AND A 3.0 NON-ABBOTT BALLOON WAS USED TO FULLY TREAT THE CALCIUM FOLLOWED BY BALLOONING AND STENT PLACEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PHYSICIAN BELIEVED THE FRACTURE OCCURRED DUE TO THE ANGULATION AND SEVERITY OF CALCIFICATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25681392 ↗
• DeathJun 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PROCEDURE TO TREAT 90% STENOSED HEAVILY CALCIFIED MID PROXIMAL CIRCUMFLEX ARTERY WITH MILD TORTUOSITY USING A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD). PERFORATION OCCURRED IN THE LEFT MAIN (LM) TO OSTIAL CIRCUMFLEX DURING ATHERECTOMY. THE PATIENT EXPERIENCED CARDIAC ARREST AND EXPIRED. IT WAS NOTED THAT THE PHYSICIAN USED CORRECT PROCEDURE TECHNIQUE AND THERE WAS NO ALLEGED MALFUNCTION OF THE DEVICE.

  Patient problems: Cardiac Arrest; Perforation of Vessels; Vascular Dissection

  MAUDE report 25616643 ↗
• DeathJun 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ATHERECTOMY WAS PERFORMED TO TREAT 80% STENOSED MODERATELY CALCIFIED, MILDLY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER MULTIPLE GUIDE SELECTIONS WERE MADE, A NON- ABBOTT WIRE WAS ADVANCED PAST THE LESION. A MICROCATHETER WAS ADVANCED OVER THE GUIDEWIRE AND EXCHANGED FOR THE VIPERWIRE CORONARY FLEX TIP GUIDEWIRE. THE MICROCATHETER WAS REMOVED AND A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS ADVANCED OVER THE VIPERWIRE CORONARY GUIDEWIRE. SEVEN TREATMENTS VARYING BETWEEN 30 AND 32 SECONDS WERE PERFORMED AT LOW SPEED. PATIENT TOLERATED WELL AND THE LESION WAS TREATED. THE PATIENT¿S PRESSURE BEGAN TO DROP AND A QUICK ANGIOGRAM WAS PERFORMED DISCOVERING A PERFORATION OF THE MID LAD. ALL ATHERECTOMY EQUIPMENT WAS REMOVED FROM THE PATIENT AND LIFE SAVING MEASURES WERE STARTED. AFTER CONSULTING WITH OTHER INTERVENTIONAL CARDIOLOGIST AND AS IT WAS UNABLE TO GET A BALLOON OR A COVERED STENT DOWN THE VESSEL, THE PATIENT WAS TRANSFERRED TO OPEN HEART SURGERY THAT WAS SUCCESSFUL. IN THE OPINION OF THE PHYSICIAN, THE OAD CAUSED PATIENT'S HYPOTENSION AND PERFORATION. THE PATIENT'S BASE HEART RATE WAS IN 70S. THE PERFORATION CAUSED BY THE OAD

  Patient problems: Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 25487925 ↗
• DeathApr 24, 2026Difficult to Remove; Material Separation; Unexpected Shutdown

  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 24984289 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING STAGED PERCUTANEOUS CORONARY INTERVENTION (PCI), RADIAL ACCESS WAS USED AS BOTH LEG ARTERIES WERE TOO COMPLICATED TO PERFORM THE PROCEDURE. A WORKHORSE WIRE WAS ADVANCED ACROSS THE LESION IN THE RIGHT CORONARY ARTERY (RCA) WITHOUT COMPLICATION, THEN A TURNPIKE WAS USED TO EXCHANGE FOR THE VIPERWIRE FLEX TIP CORONARY GUIDEWIRE. AFTER SUCCESSFULLY GETTING THE VIPERWIRE IN THE VESSEL AND ACROSS THE LESION, A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS SET UP. AFTER SEVEN TREATMENTS ON LOW SPEED, THE OAD WAS REMOVED AND A SEMI-COMPLIANT BALLOON WAS ADVANCED TO TREAT THE LESION. AFTER GOING UP ON THE BALLOON, A CINE WAS PERFORMED AND PERFORATION WAS OBSERVED IN THE PROXIMAL SEGMENT OF THE RCA. THREE COVERED STENTS AND ONE NON-COVERED STENT WERE USED ALONG WITH A SERIES OF BALLOONS SUCCESSFULLY. THE PATIENT WAS STABLE. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR FURTHER MEDICAL TREATMENT. IN THE OPINION OF THE PHYSICIAN, THE OAD CAUSED PERFORATION.

  Patient problems: Perforation of Vessels

  MAUDE report 24915407 ↗
• 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 HER UNABLE TO TOLERATE THE TREATMENT. IN THE OPINION OF THE P

  Patient problems: Cardiac Arrest; Dyspnea; Embolism/Embolus; Low Blood Pressure/ Hypotension

  MAUDE report 24729264 ↗
• InjuryMar 30, 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 24709227 ↗
• InjuryMar 18, 2026Entrapment of Device; Material Separation; Unexpected Shutdown

  IT WAS REPORTED A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING USED TO TREAT SEVERELY CALCIFIED, SEVERELY ANGULATED LEFT MAIN (LM) INTO THE LEFT CIRCUMFLEX (CX). A WORKHORSE WIRE WAS PLACED DOWN THE CX AND EXCHANGED FOR A VIPERWIRE GUIDE WIRE USING AN UNSPECIFIED MICROCATHETER. TWO LOW SPEED TREATMENTS WERE PERFORMED. DURING THE THIRD TREATMENT, THE OAD CROWN WAS MOVING RETROGRADE AND BECAME TRAPPED IN THE MID CX. THE PHYSICIAN ATTEMPTED TO USE GLIDEASSIST MODE TO FREE THE OAD, HOWEVER, THIS WAS UNSUCCESSFUL. THE OAD WAS THEN STARTED ON LOW SPEED, BUT THIS WAS UNSUCCESSFUL AND THE OAD STALLED. UPON FURTHER ANGIOGRAPHIC INSPECTION, IT WAS NOTED THE OAD DRIVESHAFT HAD FRACTURED AT THE PROXIMAL EDGE OF THE OAD CROWN. A SECOND WIRE WAS PLACED DOWN THE VESSEL, AND AN UNSPECIFIED 1.25 BALLOON WAS INFLATED SEVERAL TIMES TO ENTRAP THE FRACTURED COMPONENT. THE VIPERWIRE WAS PULLED BACK TO THE TIP OF THE OAD AND THE GUIDE CATHETER WAS ADVANCED TO THE OSTIUM OF THE CIRCUMFLEX. ALL COMPONENTS WERE REMOVED AND NOTHING REMAINED IN-VIVO. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT WAS IN STABLE CONDITION. IT WAS INDICATED THE FRACTURE MOST LIKE

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24626698 ↗
• DeathMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT ON TWO LOW SPEED TREATMENTS AND ONE HIGH SPEED TREATMENT ON A LEFT ANTERIOR DESCENDING ARTERY (LAD) AND TWO LOW SPEED TREATMENTS AND ONE HIGH SPEED TREATMENT ON A MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA). SLOW FLOW WAS OBSERVED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) POST ATHERECTOMY. THERE WERE NO ISSUES WITH THE OAD OBSERVED. THE PATIENT EXPIRED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24483654 ↗
• InjuryFeb 13, 2026Entrapment of Device; Difficult to Remove; Unexpected Shutdown

  IT WAS REPORTED THAT DURING PROCEDURE TO TREAT 80% STENOSED MILDLY TORTUOUS HEAVILY CALCIFIED MID RCA, DURING PROCEDURE TO TREAT MID RCA, THREE TREATMENTS WERE PERFORMED USING A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD). DURING THIRD TREATMENT, THE OAD STALLED AND STOPPED SPINNING. THE LIGHTS ON THE OAD WERE ON. THE OAD WAS STUCK IN THE LESION. THE PHYSICIAN ATTEMPTED TO USE GLIDE ASSIST, AND THE OAD SPUN FOR A SECOND AND THEN STOPPED. ACCESS WAS GAINED VIA THE GROIN AND THE PHYSICIAN BALLOONED THE LESION. THE OAD WAS PULLED AND REMOVED. FLOW LIMITING DISSECTION WAS OBSERVED AND A STENT WAS PLACED. THE PATIENT WAS STABLE.

  Patient problems: Vascular Dissection

  MAUDE report 24335336 ↗

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