Diamondback Peripheral DBP-EX-200SOL145Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10852528005848), received between Oct 20, 2020 and Sep 11, 2026 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, 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 ↗
• MalfunctionJun 11, 2025Improper or Incorrect Procedure or Method; Device Damaged by Another Device; Improper or Incorrect Procedure or Method; Device Damaged by Another Device

  IT WAS REPORTED THAT A PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) AND .014 VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE WERE USED FOR TREATMENT OF SEVERELY CALCIFIED, NON-TORTUOUS, 90% STENOSED LESION IN LEFT DISTAL SUPERFICIAL ARTERY (SFA) TO POPLITEAL ARTERY THROUGH FEMORAL ARTERY ACCESS. THE UNSPECIFIED PRIMARY WIRE WAS EXCHANGED WITH THE VIPERWIRE. TREATMENT STARTED ON LOW SPEED, FOLLOWED BY TWO TO THREE TREATMENTS ON MEDIUM THEN THREE TREATMENTS ON HIGH SPEED. BALLOON ANGIOPLASTY USING ABBOTT SURVEIL DRUG-COATED BALLOON (DCB) WAS PERFORMED. ANGIOGRAPHIC IMAGING POST DCB ANGIOPLASTY REVEALED VIPERWIRE FRACTURED TIP IN THE TIBIOPERONEAL (TP) TRUNK. THE FRACTURE OCCURRED ONE CM FROM THE MARKER, AND APPROXIMATELY HALF OF THE RADIOPAQUE TIP BROKE. THE FRACTURED COMPONENT WAS SUCCESSFULLY SNARED. THE PHYSICIAN BELIEVES THEY SPUN TOO CLOSE TO THE DISTAL VIPERWIRE AS THE TIP OF THE VIPERWIRE WAS OFF THE SCREEN DURING TREATMENTS. THE PATIENT WAS STABLE. THERE WAS NO OAD CROWN JUMP OR VIPERWIRE BIAS. NO DAMAGE/ISSUES PRIOR TO SEPARATION WERE OBSERVED. THERE WAS NO DIFFICULTY WIRING OR DELIVERING DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22184064 ↗
• InjuryMay 15, 2024Off-Label Use; Material Separation; Off-Label Use; Material Separation

  A DIAMONDBACK 360 EXCHANGEABLE PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF A HEAVILY CALCIFIED LESION IN THE COMMON FEMORAL ARTERY (CFA)/SUPERFICIAL FEMORAL ARTERY (SFA) BIFURCATION VIA FEMORAL UP-AND-OVER APPROACH. THE ILIAC BIFURCATION WAS STEEP, AND THE OAD CROWN COULD NOT BE ADVANCED TO THE OTHER SIDE. PULLING BACK THE SHEATH AND ADVANCING THE CROWN AND THE SHEATH AT THE SAME TIME RESOLVED THE ISSUE. THE TREATMENT WAS COMPLETED. DURING CROWN REMOVAL OVER THE WIRE FROM THE RIGHT ILIAC, THE CROWN DETACHED. A SNARE CATHETER WAS USED TO RETRIEVE THE DETACHED CROWN. THERE WERE NO FURTHER COMPLICATIONS TO THE PATIENT. IN THE OPINION OF THE PHYSICIAN, CROWN DAMAGE MIGHT HAVE OCCURRED WHILE ATTEMPTING TO ADVANCE THE CROWN UP AND OVER THE ILIAC BIFURCATION. THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19324179 ↗
• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK 360 EXCHANGEABLE ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA). A TREATMENT WAS PERFORMED ON LOW SPEED, HOWEVER, THE CROWN WAS NOT MOVING EVEN WITH THE CONTROL KNOB BEING MOVED. IT WAS OBSERVED THAT THE DRIVESHAFT WAS FRACTURED. THE PHYSICIAN SUSPECTED THE CROWN WAS ENTRAPPED IN THE SFA. ADDITIONAL PEDAL ACCESS WAS OBTAINED TO ATTEMPT TO FREE THE CROWN. UPON FURTHER REVIEW OF THE IMAGING, IT WAS DETERMINED THE DRIVESHAFT COULD LIKELY BE REMOVED BY PULLING BACK THE GUIDEWIRE. THE OAD AND WIRE WERE SUCCESSFULLY REMOVED. A NEW OAD WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16000135 ↗
• InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A SEVERELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY (SFA). INTRAVASCULAR ULTRASOUND (IVUS) WAS INSERTED INTO THE LESION, HOWEVER, MALFUNCTIONED. WHILE THE IVUS CATHETER WAS BEING EXCHANGED, THE VIPERWIRE ADVANCE GUIDE WIRE REMAINED IN THE SFA FOR APPROXIMATELY FIFTEEN MINUTES. TWO TREATMENTS ON LOW SPEED AND ONE TREATMENT ON HIGH SPEED WERE PERFORMED. THE OAD WAS REMOVED AND BALLOON ANGIOPLASTY WAS PERFORMED. ANGIOGRAPHIC IMAGING OF THE LOWER LEG REVEALED A THROMBOSIS OF THE TIBIOPERONEAL TRUNK ARTERY (TPT). A NON-CSI DEVICE WAS USED TO TREAT THE TPT AND POPLITEAL ARTERY. ANGIOGRAPHIC IMAGING WAS PERFORMED AND REVEALED A PERFORATION IN THE POPLITEAL ARTERY AND A FISTULA IN THE NEARBY VEIN. THE AREA WAS BALLOONED TO TAMPONADE. BALLOON ANGIOPLASTY AND STENT PLACEMENT WERE PERFORMED TO COMPLETE THE PROCEDURE.

  Patient problems: Fistula; Perforation of Vessels; Thrombosis/Thrombus

  MAUDE report 15932959 ↗
• MalfunctionNov 18, 2022Material Integrity Problem; Material Integrity Problem

  A DIAMONDBACK 360 EXCHANGEABLE ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A HEAVILY CALCIFIED LEFT EXTERNAL ILIAC ARTERY. TWO TREATMENTS WERE PERFORMED ON LOW SPEED, TWO ON MEDIUM SPEED, AND ONE ON HIGH SPEED. THE OAD WAS THEN ADVANCED TO THE COMMON FEMORAL ARTERY, SUPERFICIAL FEMORAL ARTERY, AND TIBIAL ARTERY. THE PHYSICIAN ELECTED TO NOT EXCHANGE THE 11CM GUIDE SHEATH FOR A LONGER SHEATH. THREE TREATMENTS WERE PERFORMED ON LOW SPEED AND ONE TREATMENT ON MEDIUM SPEED. DURING REMOVAL, THE OAD EXPERIENCED DIFFICULTY PASSING THE BIFURCATION. GLIDEASSIST WAS ACTIVATED, HOWEVER, THE DEVICE TURNED OFF. TWO FURTHER ATTEMPTS WERE MADE TO ACTIVATE GLIDEASSIST, HOWEVER, THE ISSUE PERSISTED. AN ATTEMPT TO ADVANCE THE OAD OVER THE WERE WAS PERFORMED, HOWEVER THE CROWN APPEARED TO BE STUCK TO THE LATER SIDE OF THE RIGHT ILIAC ARTERY AND AORTA JUNCTION DUE TO SUSPECTED CALCIUM. AN UNSUCCESSFUL TREATMENT ON LOW SPEED WAS ATTEMPTED. THE OAD BECAME STUCK IN THE VESSEL. WHEN CHANGING GUIDE WIRES, THE VIPERWIRE ADVANCE GUIDE WIRE WAS DIFFICULT TO REMOVE. ONCE REMOVAL WAS SUCCESSFUL, A KINK WAS OBSERVED. ANOTHER ATTEMPT TO REMOVE THE OAD WAS MADE, HOWEVER, UNSUCCESSFUL. THE SALINE SHEATH AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15828256 ↗
• InjurySep 22, 2022Mechanical Problem; Mechanical Problem

  A DIAMONDBACK 360 EXCHANGEABLE ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED SUB-INTIMAL TO TREAT A HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). WHEN TREATMENT WAS PERFORMED ON MEDIUM SPEED AND HIGH SPEED, THE OAD STALLED THREE TIMES. NO INDICATOR LIGHTS WERE BLINKING WHILE THE DEVICE STALLED. AN ANGIOGRAM WAS PERFORMED AND REVEALED A SEVERE DISSECTION. THE OAD WAS REMOVED. BALLOON ANGIOPLASTY AND STENT PLACEMENT WERE PERFORMED TO RESOLVE THE DISSECTION. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OVERNIGHT OBSERVATION. THE PATIENT WAS STABLE AND DISCHARGED.

  Patient problems: Vascular Dissection

  MAUDE report 15463325 ↗
• InjuryJun 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S VASCULATURE EXHIBITED TWO-VESSEL RUNOFF WITH THE ANTERIOR TIBIAL AND PERONEAL ARTERIES OPEN PRIOR TO ATHERECTOMY WITH A DIAMONDBACK EXCHANGEABLE SERIES ORBITAL ATHERECTOMY DEVICE (OAD). THE SUPERFICIAL FEMORAL ARTERY WAS TREATED WITH OA FOLLOWED BY A NON-CSI DEVICE. NO FLOW WAS THEN SEEN ON IMAGING IN THE PERONEAL ARTERY. THIS WAS RESOLVED WITH BALLOON ANGIOPLASTY, WHICH WAS APPLIED TO THE PROXIMAL PERONEAL ARTERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12075432 ↗
• InjuryMar 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK PERIPHERAL EXCHANGEABLE ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A CHRONIC TOTAL OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY. THREE TREATMENT PASSES WERE PERFORMED AT LOW SPEED AND TWO AT HIGH SPEED. THE OAD WAS REMOVED AND BALLOON ANGIOPLASTY WAS PERFORMED. ANGIOGRAPHY WAS PERFORMED OF THE VESSEL RUN OFF AND AN EMBOLISM WAS OBSERVED IN THE AREA OF THE POPLITEAL ARTERY. A THROMBECTOMY CATHETER WAS USED AND THE AREA IMPROVED, HOWEVER A MORE DISTAL EMBOLISM WAS OBSERVED AND FLOW WAS LOST TO THE DORSALIS PEDIS. THE PATIENT WAS ASYMPTOMATIC BUT WAS PLACED ON HEPARIN AND MONITORED OVERNIGHT TO ADDRESS THE NO FLOW. AS OF 15 MARCH, THE PATIENT WAS IN STABLE CONDITION. PER THE PHYSICIAN THE CAUSE OF THE EMBOLISM WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Embolism/Embolus

  MAUDE report 11575853 ↗
• InjuryOct 20, 2020Entrapment of Device; Mechanical Problem; Entrapment of Device; Mechanical Problem

  DURING A PERIPHERAL PROCEDURE, THE PERIPHERAL EXCHANGEABLE ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) OF THE SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS 120 MM IN LENGTH WITH 100% STENOSIS AND 90% CALCIFICATION, AND THE VESSEL WAS 6MM IN DIAMETER. AFTER 2 TREATMENTS ON LOW SPEED, ONE TREATMENT ON MEDIUM SPEED, AND TWO TREATMENTS ON HIGH SPEED, THE OAD SEEMED TO STALL AND COULD NOT BE PULLED BACK INTO THE SHEATH. VESSEL SPASMS OCCURRED AND WERE TREATED WITH NITROGLYCERIN. THE DEVICE WAS PULLED WITH CONSIDERABLE FORCE TO BE PULLED BACK INTO THE 6FR SHEATH. TISSUE AND DEBRIS WERE NOTED ON THE OAD CROWN. CLOTS BEGAN FORMING IN THE VESSEL, AND THE CLOTS WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY AND STENT PLACEMENT. IN THE OPINION OF THE PHYSICIAN, THE CLOTS WERE LOCATED WITHIN THE CTO LESION WHEN THE LESION WAS TREATED WITH ORBITAL ATHERECTOMY, AND THE CLOTS WERE CAUSED BY THE PATIENT'S CLOTTING DISORDER. IT WAS REPORTED THAT THE PATIENT WAS HEPARINIZED WITH 3000 UNITS OF HEPARIN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10706507 ↗