Levó Arm 7887-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00842430104992), received between Jul 27, 2018 and Sep 2, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2026Insufficient Device Problem Information

  Patient problems: Laceration(s)

  MAUDE report 50569935 ↗
• MalfunctionNov 10, 2022Corroded; Unintended System Motion; Device Slipped; Corroded; Unintended System Motion; Device Slipped

  IT WAS REPORTED THAT THE LEVÓ ARM MOVED ON ITS OWN IN THE MIDDLE OF THE SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 15777246 ↗
• MalfunctionMay 12, 2020Unintended Movement; Unintended Movement

  WE HAD A CASE THIS MORNING USING IT FOR THE FIRST TIME AND AFTER THE CASE WHEN I WAS PUTTING THE LEVO ARM AWAY I NOTICED THAT ALL OF A SUDDEN IT COULD BE ENGAGED WITH PRESSING ONLY ONE BUTTON INSTEAD OF BOTH THE DARK BLUE AND BABY BLUE AT THE SAME TIME. SHORTLY AFTER IT WOULD WORK NORMALLY WITH BOTH BUTTONS PRESSED AS IT SHOULD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10048418 ↗
• MalfunctionFeb 21, 2020Corroded; Corroded

  THE LEVO ARM WAS BEING POSITIONED PREOPERATIVELY AND FULL MOVEMENT AND FUNCTION OF THE ARM WAS NOT AVAILABLE. THE BALL JOINT ARTICULATION POINT IMMEDIATELY POSTERIOR TO THE RELEASE BUTTON AND HANDLE WAS NOT MOVING FREELY. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. EVIDENCE OF FLUID INGRESS AND CORROSION WAS FOUND FAILURES WITH A POTENTIAL TO CAUSE UNEXPECTED MOTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9739065 ↗
• MalfunctionDec 19, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING HIS CASE HE THOUGHT THE PATIENTS HEAD "MOVED'. THE SURGEON AND HIS TECH SAID IT MIGHT HAVE MOVED BUT THEY WERE NOT SURE IT WAS THE POSITIONER OR SOMETHING ELSE. THE CASE WENT ON WITHOUT ANY ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9497523 ↗
• MalfunctionDec 9, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A "CLICKING NOISE" WAS HEARD AND OBSERVED MOVEMENT OF THE PATIENT'S HEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9439161 ↗
• MalfunctionOct 28, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED NEARING THE END OF THE PROCEDURE THE LEVO ARM GAVE OUT AND WAS COMPLETELY LIMP/MOVEABLE WITHOUT PRESSING EITHER BUTTON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9247202 ↗
• MalfunctionAug 16, 2019Electrical Shorting; Unintended Movement; Electrical Shorting; Unintended Movement

  IT WAS REPORTED THAT 30 TO 45 MINUTES INTO THIS CASE THE SURGEONS NOTICED THAT THE HEAD OF THE PATIENT WAS SLOWLY MOVING DOWNWARD. ONE SURGEON HAD TO BREAK SCRUB TO STOP IT FROM MOVING DOWN ANY FURTHER WHILE THE OTHER SURGEON HELD THE PATIENT'S HEAD AT THE SKULL CLAMP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8903051 ↗
• MalfunctionAug 16, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THE BALL JOINT WOULD NOT STAY IN LOCKED POSITION WHILE THE SKULL CLAMP WAS ATTACHED TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8902857 ↗
• MalfunctionJun 3, 2019Electrical Shorting; Unintended Movement; Electrical Shorting; Unintended Movement

  IT WAS REPORTED THE LEVO ARM WAS IN USE AND LOCKED WHILE A PATIENTS HEAD WAS CONNECTED TO THE SKULL CLAMP. THE LEVO ARM RELEASED AND THE PATIENTS HEAD DROPPED WITHOUT ANY RELEASE BUTTONS BEING DEPRESSED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8664256 ↗
• MalfunctionMay 8, 2019Electrical Shorting; Unintended Movement; Electrical Shorting; Unintended Movement

  IT WAS REPORTED THE LEVÓ ARM WAS BEING CLEANED FOLLOWING A CASE. EQUIPMENT TECH NOTICED ARM MOVE WITHOUT ENGAGING LIGHT BLUE OR DARK BLUE BUTTONS ON PISTOL GRIP CONTROL DURING CLEANING. LEVÓ ARM REMOVED FROM DUAL MOTION BASE AND NOTICED CONTINUED MOVEMENT WITHOUT ENGAGING BUTTONS. CLICKING NOISE HEARD WHILE PRESSING LIGHT BLUE AND DARK BLUE BUTTON INDIVIDUALLY ON PISTOL GRIP

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8591692 ↗
• MalfunctionJul 27, 2018Unintended Movement; Unintended Movement

  DURING CERVICAL SPINE CASE THE ARM WAS MOVING FROM THE BALL JOINT AREA OF THE DEVICE WITHOUT ENGAGING CONTROL HANDLES. PATIENT'S HEAD WAS CONNECTED TO SKULL CLAMP AND ATTACHED VIA QUICK CONNECT. SURGEON COULD MANUALLY MOVE THE HEAD BY PUSHING ON CONTROL HANDLES TO CREATE FULL RANGE OF MOTION WITHOUT PRESS LIGHT BLUE OR DARK BLUE BUTTONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7728259 ↗