Diamondback Peripheral DBP-125MICRO60Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10852528005206), received between Apr 13, 2017 and Sep 23, 2020 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2020Entrapment of Device; Entrapment of Device

  A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF LESIONS IN THE POPLITEAL (PT) AND ANTERIOR TIBIAL (AT) ARTERIES. PEDAL ACCESS VIA THE AT WAS OBTAINED. ORBITAL ATHERECTOMY WAS SUCCESSFULLY COMPLETED IN THE PT AND TREATMENT WAS CONTINUED IN THE AT. THE OAD WAS OPERATED ON LOW AND MEDIUM SPEED WITHOUT ISSUE, HOWEVER THE OAD STOPPED SPINNING ON HIGH SPEED. PER THE OPINION OF THE PHYSICIAN, THE DEVICE WAS STUCK ON THE WIRE. A TROUBLESHOOTING ATTEMPT TO SPIN THE DEVICE OFF OF THE WIRE WAS PERFORMED BUT WAS UNSUCCESSFUL. THE OAD AND WIRE WERE REMOVED TOGETHER. AN ANGIOGRAM WAS PERFORMED AND REVEALED A TYPE C DISSECTION IN THE AT ARTERY. TWO FOUR-MINUTE BALLOON INFLATIONS WERE PERFORMED TO TAMPONADE THE DISSECTION. A FINAL ANGIOGRAPHY SHOWED THAT THE DISSECTION WAS RESOLVED. AFTER THE PROCEDURE A PRESSURE DRESSING WAS APPLIED, AND BLOOD THINNERS WERE ADMINISTERED TO ENSURE THE DISSECTION WAS RESOLVED. THE PATIENT WAS REPORTED TO BE FINE THE FOLLOWING DAY. PER THE OPINION OF THE PHYSICIAN, THE OAD MAY HAVE ACCUMULATED TISSUE WHILE STUCK ON THE WIRE OR DURING REMOVAL AND CONTRIBUTED TO THE DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 10572724 ↗
• InjuryJul 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE WITH A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD), A VESSEL PERFORATION OCCURRED, AND A SUBSEQUENT STENT WAS DEPLOYED.

  Patient problems: Perforation of Vessels

  MAUDE report 10248670 ↗
• MalfunctionAug 13, 2019Entrapment of Device; Failure to Shut Off; Material Integrity Problem; Entrapment of Device; Failure to Shut Off; Material Integrity Problem

  DURING A PROCEDURE, THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WOULD NOT TURN OFF. THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY AND WAS ACCESSED VIA A PEDAL APPROACH. DURING THE INITIAL TREATMENT PASS, THE OAD CAME INTO CONTACT WITH CALCIUM AND WOULD NOT STOP SPINNING. THE OAD REMOVED FROM THE PATIENT WHILE IT WAS STILL SPINNING AND WAS UNPLUGGED TO STOP THE DEVICE. IT WAS NOTED THAT THE TIP OF THE VIPERWIRE SEEMED SPONGY, BUT THERE WERE NO FRACTURES OBSERVED. A SECOND OAD AND BALLOON ANGIOPLASTY WERE USED TO COMPLETE THE PROCEDURE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8888134 ↗
• MalfunctionMay 2, 2019Entrapment of Device; Entrapment of Device

  THE PERIPHERAL DIAMONDBACK ORBITAL ATHERECTOMY DEVICE (OAD) BECAME STUCK ON THE GUIDE WIRE DURING TREATMENT IN THE ANTERIOR TIBIAL ARTERY. THE OAD AND WIRE WERE REMOVED TOGETHER. THE VESSEL WAS REWIRED AND THE PROCEDURE WAS COMPLETED VIA ATHERECTOMY WITH A SECOND OAD, AND BALLOON ANGIOPLASTY. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE WAS DELAYED BY THIRTY MINUTES OR GREATER DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8573516 ↗
• InjuryApr 2, 2019Noise, Audible; Noise, Audible

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI DIAMONDBACK ORBITAL ATHERECTOMY DEVICE (OAD), A DISSECTION OCCURRED. DURING ATHERECTOMY TREATMENT, THE DEVICE MADE AN UNUSUAL NOISE. FOLLOWING REMOVAL OF THE OAD, A DISSECTION WAS NOTED IN THE AREA OF THE SHEATH. A BALLOON WAS INFLATED AT THE SITE OF THE DISSECTION FOR THREE MINUTES TO RESOLVE IT AND THE PATIENT WAS IN STABLE CONDITION. PER THE PHYSICIAN, THE CAUSE OF THE DISSECTION WAS UNKNOWN. THE PATIENT PRESENTED WITH BRUISING THE DAY FOLLOWING THE PROCEDURE. NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Bruise/Contusion; Vascular Dissection

  MAUDE report 8475233 ↗
• InjuryApr 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, A PERFORATION OCCURRED WHILE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD). THE TARGET LESION WAS 5 MM IN LENGTH AND WAS LOCATED IN THE ANTERIOR TIBIAL (AT) ARTERY. DURING THE THIRD RUN AT LOW SPEED, THE DEVICE PITCH CHANGED. THE OAD WAS REMOVED AND ANGIOGRAPHY REVEALED A PERFORATION. THE PHYSICIAN INFLATED A BALLOON ACROSS THE PERFORATION FOR THREE MINUTES AND SUCCESSFULLY RESOLVED IT. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS DENIED BY THE FACILITY.

  Patient problems: Perforation of Vessels

  MAUDE report 6491494 ↗