Diamondback Peripheral DBP-150SOLID145 (REF 7-10057-03)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10850000491196), received between Oct 29, 2020 and Mar 30, 2026 — classified as 8 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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 THE OAD CROWN WAS RETRACTED.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 ↗
• MalfunctionMay 9, 2025Break; Break

  IT WAS REPORTED THAT THE SALINE TUBING OF THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) HAD A PUNCTURE FROM THE LUBRICANT TO THE OAD. THE DATE OF EVENT WILL BE ESTIMATED AS (B)(6) 2025. NO ADDITIONAL INFORMATION WAS MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993906 ↗
• MalfunctionApr 8, 2025Material Separation; Insufficient Flow or Under Infusion; Detachment of Device or Device Component; Material Separation; Insufficient Flow or Under Infusion; Detachment of Device or Device Component

  A DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) AND VIPERWIRE PERIPHERAL GUIDE WIRE WERE USED TO TREAT A SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE FIRST TREATMENT ON LOW SPEED, BLOOD WAS OBSERVED TO BE BACKING UP IN THE CATHETER. FURTHER INSPECTION REVEALED THE CATHETER WAS DETACHED FROM THE STRAIN RELIEF WHICH PREVENTED FROM SALINE FLOWING TO THE PATIENT. BLOOD WAS DRIPPING AT THE SEPARATION LOCATION. THE CATHETER WAS RECONNECTED TO THE STRAIN RELIEF, HOWEVER, THE PHYSICIAN ELECTED TO REPLACE THE OAD TO COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE AND THERE WERE NO PATIENT ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21800451 ↗
• MalfunctionApr 3, 2025Break; Unintended System Motion; Break; Unintended System Motion

  IT WAS REPORTED THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS PREPPED CORRECTLY AND WHEN THE PHYSICIAN ATTEMPTED THE FIRST TREATMENT IN THE SUPERFICIAL FEMORAL ARTERY (SFA), IT WAS OBSERVED THE OAD WAS NOT FUNCTIONING AS INTENDED. THE GUIDE WIRE BRAKE APPEARED DEFECTIVE. WHEN ENGAGED, IT WAS STILL LOOSE ON THE VIPERWIRE GUIDE WIRE. A NEW OAD WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21764470 ↗
• InjuryJul 26, 2023Entrapment of Device; Entrapment of Device

  A DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) BECAME STUCK IN THE 95% STENOSED, MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERY (AT) AND A PERFORATION OCCURRED. BALLOON ANGIOPLASTY, A COVERED STENT, AND A NON-CSI DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Perforation of Vessels

  MAUDE report 17395989 ↗
• InjuryFeb 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A WIRE AND SUPPORT CATHETER WERE ADVANCED INTO THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY (PA). THE NON-CSI WIRE WAS EXCHANGED FOR A VIPERWIRE ADVANCE GUIDE WIRE. A TREATMENT WAS RUN ON LOW SPEED, MEDIUM SPEED, AND MULTIPLE TREATMENTS ON HIGH SPEED WERE PERFORMED ON THE SFA AND PA USING A DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE. BALLOON ANGIOPLASTY WAS PERFORMED ON THE SFA AND PA. DISTAL NO FLOW WAS SUSPECTED AT THE DISTAL ANTERIOR TIBIAL (AT) LESION. ATTEMPTS WERE MADE TO CROSS THE AT LESION FROM THE FEMORAL APPROACH, HOWEVER, WAS UNSUCCESSFUL DUE TO HEAVY CALCIFICATION AND TORTUOSITY. AN ATTEMPT WAS MADE TO CROSS A BALLOON IN THE AT LESION, HOWEVER, WAS UNSUCCESSFUL. PEDAL AT ACCESS WAS UNSUCCESSFUL. ADDITIONAL TROUBLESHOOTING WAS PERFORMED TO CROSS THE LESION, HOWEVER, CONTINUED TO BE UNSUCCESSFUL. FLOW WAS NOT RESTORED DISTAL TO AT LESION. THE PROCEDURE WAS COMPLETED WITH ANTICIPATION FOR AN ADDITIONAL ATHERECTOMY PROCEDURE. THE PATIENT WAS STABLE.

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

  MAUDE report 16283368 ↗
• MalfunctionJul 7, 2022Material Separation; Material Separation

  AT THE CONCLUSION OF AN ATHERECTOMY PROCEDURE USING A DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD), THE PHYSICIAN EXPERIENCED DIFFICULTY WHILE REMOVING THE OAD FROM THE SHEATH. THE PHYSICIAN IDENTIFIED THAT THE OAD CROWN REMAINED IN VIVO WHILE PERFORMING BALLOON ANGIOPLASTY. FLUOROSCOPY REVEALED THAT THE 1.50 CROWN WAS IMMOBILE AND REMAINED IN THE DISTAL PORTION OF THE SUPERFICIAL FEMORAL ARTERY (SFA). A STENT WAS DEPLOYED, ENTRAPPING THE CROWN IN THE VESSEL WALL. THE PATIENT'S CONDITION WAS STABLE. THE PROCEDURE WAS COMPLETED WITH GOOD FLOW TO THE LOWER EXTREMITY.

  Patient problems: Foreign Body In Patient

  MAUDE report 14950058 ↗
• InjuryJun 22, 2022Entrapment of Device; Entrapment of Device

  TREATMENT WAS SUCCESSFULLY PERFORMED PROXIMAL TO DISTAL ON LOW SPEED IN THE SEVERELY CALCIFIED, 3.0 MM ANTERIOR TIBIAL (AT) ARTERY USING A DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD). WHEN SPEED WAS INCREASED FROM LOW TO MEDIUM SPEED, THE OAD WAS UNABLE TO ADVANCE FROM A SEVERELY CALCIFIED LESION IN THE MID AT. THE PHYSICIAN CUT THE DEVICE AND REMOVED IT USING SURGICAL SCISSORS. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO REMOVE THE OAD FROM ABOVE AND BELOW THE KNEE. PEDAL ACCESS WAS OBTAINED AND THE WIRE WAS REMOVED FROM THE FOOT USING A SNARE. THE PATIENT WAS TRANSFERRED TO SURGERY AND THE OAD WAS REMOVED. THE PATIENT WAS IN GOOD CONDITION POST-SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 14776796 ↗
• InjuryAug 25, 2021Entrapment of Device; Entrapment of Device

  ORBITAL ATHERECTOMY WAS SELECTED FOR TREATMENT OF THE ANTERIOR TIBIAL ARTERY. FIELD STAFF SUGGESTED USING AN OAD WITH A SMALLER CROWN DUE TO VESSEL SIZE, HOWEVER THE PHYSICIAN USED A 1.5 SOLID CROWN OAD. DURING TREATMENT, THE WIRE TIP MARKER COULD NOT BE SEEN VIA FLUOROSCOPY, AND THE OAD STALLED. THE WIRE AND CONTROL KNOB WERE ABLE TO MOVE, HOWEVER THE CROWN DID NOT MOVE. THE OAD WAS PULLED, HOWEVER IT REMAINED STUCK, AND THE CATHETER WAS CUT FROM THE HANDLE. THERE WERE NO AVAILABLE CATHETERS THAT WOULD FIT OVER THE DEVICE, AND A SECOND ACCESS SITE WAS OBTAINED. THE VESSEL WAS WIRED AND BALLOON INFLATION WAS PERFORMED NEXT TO THE CROWN. THE PATIENT BECAME UNRESPONSIVE AND THE CROWN COULD NOT BE REMOVED. A VESSEL PERFORATION WAS IDENTIFIED IN THE AORTA, BETWEEN THE RENAL ARTERIES AND ILIAC BIFURCATION AND THE PATIENT WAS SENT TO THE OPERATING ROOM. THE PATIENT EXPIRED DUE TO COMPLICATIONS IN THE AORTA UNRELATED TO THE CSI DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12365833 ↗
• InjuryJun 8, 2021Entrapment of Device; Entrapment of Device

  A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF LESIONS IN THE SUPERFICIAL FEMORAL ARTERY (SFA), POPLITEAL AND PERONEAL ARTERIES. THE SFA AND POPLITEAL ARTERIES WERE TREATED. ONE TREATMENT WAS PERFORMED IN WHAT WAS THOUGHT TO BE THE PERONEAL ARTERY. DURING TREATMENT, THE OAD CROWN BECAME STUCK. A FEMORAL DISTAL BYPASS WAS PERFORMED, AND THE OAD WAS REMOVED. FOLLOWING THE PROCEDURE, THE PATIENT WAS RECOVERING WELL. CSI LATER RECEIVED INFORMATION THAT A LEG AMPUTATION WAS PERFORMED, HOWEVER IT IS UNKNOWN WHEN THIS OCCURRED AND IF IT WAS RELATED TO THE STUCK IN VESSEL EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11962313 ↗
• InjuryApr 9, 2021Entrapment of Device; Entrapment of Device

  ORBITAL ATHERECTOMY TREATMENT WAS SELECTED FOR SUPERFICIAL FEMORAL (SFA), POSTERIOR TIBIAL (PT) AND POPLITEAL ARTERIES. THE LESION WAS A SHORT CHRONIC TOTAL OCCLUSION AND THE VESSEL WAS PRIMARY WIRED WITH A NON-CSI WIRE. THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE WAS OPERATED IN THE SFA ON ALL THREE SPEEDS AND IN THE PT ON LOW SPEED WITHOUT ISSUE. WHEN OPERATED ON MEDIUM SPEED IN THE PT THE OAD SOUNDED AS THOUGH IT HAD SPUN IN TISSUE, STOPPED SPINNING, AND WAS STUCK IN THE VESSEL. THE OAD WAS MANUALLY PULLED TO LREMOVAL AND TISSUE WAS OBSERVED AROUND THE TIP OF THE DEVICE. IMAGING DID NOT REVEAL ANY ISSUES, AND BALLOON ANGIOPLASTY WAS PERFORMED. IMAGING IDENTIFIED A VESSEL PERFORATION. BALLOON ANGIOPLASTY WAS UNSUCCESSFULLY ATTEMPTED FOR OVER 30 MINUTES, AND A STENT WAS PLACED TO RESOLVE THE PERFORATION. THE PROCEDURE WAS CONTINUED WITHOUT FURTHER COMPLICATIONS, AND THE PATIENT WAS IN GOOD CONDITION FOLLOWING THE PROCEDURE. PER THE OPINION OF THE PHYSICIAN, THE NON-CSI PRIMARY WIRE WAS LIKELY ADVANCED TO A SUBINTIMAL LOCATION, AND THE OAD WAS THEN OPERATED SUBINTIMALLY.

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

  MAUDE report 11645593 ↗
• InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED TO TREAT A HEAVILY CALCIFIED, 90% STENOSED LESION IN THE LEFT POSTERIOR TIBIAL ARTERY. THE VESSEL WAS 3.0 MM IN DIAMETER. DURING TREATMENT, THE PATIENT INADVERTENTLY BENT THEIR KNEE AND CAUSED THE CROWN TO MOVE LATERALLY. THE OAD STALLED AND WAS REMOVED FROM THE PATIENT, AND IMAGING IDENTIFIED A VESSEL PERFORATION. BALLOON ANGIOPLASTY AND STENT PLACEMENT WERE PERFORMED TO THE PERFORATION SITE AND A BLOOD PRESSURE CUFF WAS PLACED ON THE PATIENT'S LEG TO TAMPONADE THE PERFORATION. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE AND THE PATIENT WAS REPORTED TO BE DOING WELL. PER THE OPINION OF THE PHYSICIAN, THE PATIENT'S MOVEMENT WAS THE PRIMARY FACTOR IN THE CAUSE OF THE PERFORATION EVENT.

  Patient problems: Perforation of Vessels

  MAUDE report 11059236 ↗
• MalfunctionOct 29, 2020Entrapment of Device; Entrapment of Device

  THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE WAS OPERATED IN THE POPLITEAL ARTERY AT LOW SPEED FOR THREE TREATMENT PASSES. THE BRAKE WAS UNLOCKED AND THE OAD WAS ADVANCED TO THE NEXT LESION. THREE TREATMENT PASSES WERE PERFORMED AT LOW SPEED. AS THE OAD WAS REMOVED FROM THE VESSEL, IT WAS STUCK ON THE GUIDE WIRE AND THE GUIDE WIRE MOVED WITH THE OAD. DESPITE TROUBLESHOOTING ATTEMPTS, THE OAD REMAINED STUCK ON THE GUIDE WIRE. A SECOND WIRE WAS INSERTED INTO THE GUIDE CATHETER TO MAINTAIN WIRE ACCESS AND THE OAD AND WIRE WERE REMOVED TOGETHER. THE PROCEDURE WAS CONTINUED WITH BALLOON ANGIOPLASTY. A DELAY OF 30 MINUTES OR GREATER OCCURRED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10759125 ↗