VersaStep VS101000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20884521084145), received between Nov 8, 2018 and Apr 19, 2021 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryApr 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE PATIENT HAD A LAPAROSCOPIC SURGERY LAST YEAR. THE PATIENT RETURNED TO THE HOSPITAL FROM WOUND INFECTION PAIN AND WAS TAKEN BACK TO SURGERY. THE SURGEON FUND NOTHING WRONG. THEN, THE PATIENT WENT TO ANOTHER HOSPITAL AND IS CLAIMING THAT THERE WAS A FOREIGN MATERIAL FROM THE EXPANDABLE SLEEVE LEFT BEHIND.

  Patient problems: Foreign Body In Patient; Pain; Post Operative Wound Infection

  MAUDE report 11685053 ↗
• MalfunctionNov 6, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CANNULA INSERTION ON A LAPAROSCOPIC NISSEN, THE SEAL OF THE DEVICE DISENGAGED AND THE EXPANDABLE RETRACTED AFTER INSERTION WITH THE STEP NEEDLE TO SUCH AN EXTENT THAT THE PORT WOULD PUNCTURE THE SLEEVE WHEN INSERTED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9283944 ↗
• InjuryJul 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, A SHEATH WAS RETAINED ON FROM THE ORIGINAL SURGERY AND WAS NOT DISCOVERED UNTIL A SUBSEQUENT INCISIONAL HERNIA REPAIR. A SURGICAL INTERVENTION WAS DONE TO PREVENT A PERMANENT IMPAIRMENT. THE SHEATH WAS REMOVED FROM THE PATIENT¿S CAVITY.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 8807191 ↗
• MalfunctionNov 8, 2018Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, AT THE BEGINNING OF THE LAPAROSCOPIC BYPASS REVISION, THEY TRIED TO PLACE THE OBTURATOR DOWN THE RADIAL EXPANDABLE SLEEVE, BUT THE OBTURATOR GOT STUCK IN THE RADIALLY EXPANDABLE SLEEVE. THEY PLACED THE LIVER RETRACTOR INTO AN INCISION WITHOUT A TROCAR TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8050765 ↗