SIDEKICK® SD110ATRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741067815), received between Nov 16, 2016 and Feb 13, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Bent” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionFeb 13, 2018Bent; Retraction Problem; Failure to Advance; Bent; Retraction Problem; Failure to Advance

  IT WAS REPORTED THAT DURING A CTO CROSSING PROCEDURE IN THE LEFT SFA, THE SUPPORT CATHETER ALLEGEDLY WOULD NOT ADVANCE TOWARDS THE LESION AND THE RECANALIZATION CATHETER ALLEGEDLY WOULD NOT RETRACT THROUGH THE SUPPORT CATHETER. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER (HCP) REMOVED THE RECANALIZATION AND SUPPORT CATHETERS TOGETHER AS A SINGLE UNIT. THE HCP ATTEMPTED TO CROSS THE PROXIMAL CAP WITH A GUIDEWIRE BUT WAS UNSUCCESSFUL; THEREFORE, THE PROCEDURE WAS CONCLUDED AND NO FURTHER TREATMENT WAS PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7267667 ↗
• MalfunctionNov 16, 2016Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING ADVANCEMENT IN AN INSTENT STENOSIS IN THE SFA, THE SUPPORT CATHETER ALLEGEDLY BECAME STUCK IN AN EXISTING BARE METAL STENT. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER (HCP) RETRIEVED THE SUPPORT AND RECANALIZATION CATHETERS, AS ONE UNIT, RESULTING IN AN ALLEGED TIP DETACHMENT OF THE SUPPORT CATHETER. REPORTEDLY, THE DETACHED TIP REMAINED IN THE VESSEL AND THE HCP DECIDED TO LEAVE THE TIP IN PLACE AS IT WAS PREARRANGED TO USE A NEW COVERED SELF EXPANDING STENT TO OVERLAP THE ENTIRE EXISTING BARE METAL STENT WHICH ALSO SECURED THE DETACH TIP. ANOTHER SUPPORT CATHETER WAS REPORTEDLY USED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6106758 ↗