Viperslide VPR-SLD2Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10852528005121), received between Dec 27, 2024 and Mar 6, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING COMPLETION OF TREATMENT WITH 1.25 MICRO DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) IN THE HEAVILY CALCIFIED, MILDLY TORTUOUS, OVER 70% STENOSED POSTERIOR TIBIAL ARTERY (PT), THE PATIENT SHOWED SIGNS OF ANAPHYLACTIC SHOCK INCLUDING HIVES, NAUSEA AND LOW BLOOD PRESSURE WHICH LED TO A CODE. THE PATIENT WAS KEPT AN ADDITIONAL NIGHT FOR OBSERVATION. THE PATIENT WAS STABILIZED AND EXTUBATED 24 HOURS LATER. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE. THE PHYSICIAN INITIALLY THOUGHT THAT THE ALLERGIC REACTION COULD BE DUE TO THE VIPERSLIDE LUBRICANT SOLUTION USED BUT FURTHER DISCUSSIONS WITH THE ABBOTT SALES REP SHOWED THE PATIENT HAD NO LISTED ALLERGIES ASSOCIATED WITH THE INGREDIENTS IN VIPERSLIDE. DURING FOLLOW UP WITH THE PHYSICIAN ON THE PATIENT'S STATUS 24 HOURS AFTER THE PROCEDURE, THE PHYSICIAN INDICATED THEY WERE UNSURE WHAT CAUSED THE PATIENT¿S REACTION.

  Patient problems: Anaphylactic Shock; Low Blood Pressure/ Hypotension

  MAUDE report 24532250 ↗
• MalfunctionApr 11, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED AN EXPIRED VIPERSLIDE LUBRICANT WAS USED KNOWINGLY. THE CASE WAS SUCCESSFUL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21827284 ↗
• MalfunctionJan 2, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED EXPIRED VIPERSLIDE WAS USED DURING A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057800 ↗
• MalfunctionDec 27, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED A VIPERSLIDE INTEGRITY INDICATOR TURNED BLACK. IT WAS INDICATED THE VIPERSLIDE POUCH HAD NO VISIBLE DAMAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028217 ↗