MyoCycle MC-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00861553000417), received between Aug 11, 2022 and Jan 19, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 19, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT (PT) IS A 75 YEAR OLD WOMAN WITH A HISTORY OF MUSCLE WEAKNESS AND PARALYSIS SECONDARY TO A SPINAL CORD INJURY (SCI) THAT OCCURRED OVER 40 YEARS AGO, AND SHE HAS BEEN A FULL-TIME WHEELCHAIR USER SINCE HER SCI. PT ALSO HAS A HISTORY OF OSTEOPOROSIS, BUT SHE CANNOT SAY WHEN SHE WAS DIAGNOSED EXCEPT THAT IT WAS "YEARS" AGO, AND SHE HAS NOT BEEN MONITORING OR UNDERGOING ANY TREATMENT FOR HER OSTEOPOROSIS. THE PT WAS ALSO RECENTLY DIAGNOSED WITH "CLUB FOOT" CAUSED BY CONTRACTURES RESULTING FROM NON-WEIGHT BEARING OVER MANY YEARS. THE PT HAD BEEN USING A DEVICE SIMILAR TO THE SUSPECT DEVICE AS PART OF CLINICAL REHABILITATION IN PRIOR YEARS, BUT THIS OTHER DEVICE FAILED 2 YEARS AGO, PROMPTING THE PT TO PURSUE PURCHASE OF THE SUSPECT DEVICE. ON (B)(6) 2022, PT WAS PRESCRIBED THE SUSPECT DEVICE BY A LICENSED PHYSICIAN WHO REVIEWED THE PT'S MEDICAL HISTORY AND THE DEVICE INDICATIONS AND CONTRAINDICATIONS, AND SHE BEGAN USING THE DEVICE AT HOME ON (B)(6) 2022 AFTER REMOTE TRAINING WITH A LICENSED PHYSICAL THERAPIST. THE DEVICE IS A WHEELCHAIR ACCESSIBLE STATIONARY BIKE WITH INTEGRATED FUNCTIONAL ELECTRICAL STIMULATION (FES) FOR UP TO 10 MUSCLE GROUPS AT ONCE AND PEDALING ASSISTANCE/RES

  Patient problems: Limb Fracture

  MAUDE report 16203668 ↗
• MalfunctionAug 11, 2022Mechanical Problem; Mechanical Problem

  ON (B)(6) 2022, MYOLYN RECEIVED A CUSTOMER COMPLAINT ABOUT MYOCYCLE MC-2 (B)(4) FAILING TO POWER ON. MYOLYN INITIATED A VIDEO CALL WITH THE CUSTOMER TO INVESTIGATE THE CAUSE. DURING THE CALL, THE CUSTOMER HEARD LOOSE SCREWS INSIDE THE DEVICE POWER ELECTRONICS BOX. THE CUSTOMER REMOVED THIS BOX AND RETURNED IT TO MYOLYN FOR FURTHER INVESTIGATION, WHERE IT WAS FOUND THAT THE LOOSE SCREWS WERE THOSE INTENDED FOR MOUNTING THE DEVICE POWER SUPPLY IN PLACE INSIDE THE POWER ELECTRONICS BOX. INVESTIGATION ALSO REVEALED THAT ONE SCREW HAD CAUSED AN ELECTRICAL SHORT CIRCUIT ON THE POWER SUPPLY INPUT, RESULTING IN FAILURE OF THE POWER SUPPLY. MYOLYN CONCLUDED THAT THE POWER SUPPLY MOUNTING SCREWS HAD COME LOOSE DURING SHIPPING AS A RESULT OF VIBRATION AND MECHANICAL SHOCK. LOOSE POWER SUPPLY MOUNTING SCREWS CAN RESULT IN A LOSS OF PROTECTION AGAINST HIGH VOLTAGE ELECTRICAL SHOCK, INCREASING THE RISK FOR SERIOUS INJURY AND/OR DEATH, WITH THE RISK BEING PROPORTIONATE TO THE NUMBER OF LOOSE SCREWS (OUT OF FOUR) AND DEGREE OF LOOSENING (I.E., PARTIALLY LOOSE SCREWS REPRESENT A MUCH LOWER RISK THAN COMPLETELY LOOSE SCREWS).

  Patient problems: Electric Shock

  MAUDE report 15209093 ↗