VersaStep Plus VS100712PRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521082823), received between Jan 29, 2018 and Nov 28, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 28, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT WAS DIAGNOSED WITH A PNEUMOTHORAX AND BROUGHT TO THE OPERATING ROOM FOR A VIDEO-ASSISTED THORASCOPIC SURGERY (VATS). DURING THE PROCEDURE BEFORE CLOSING, IT WAS NOTED THAT AN IRREGULAR YET OVAL-SHAPED PIECE OF PLASTIC PORT MEASURING APPROXIMATELY 2.5 X 4 MILLIMETERS HAD BROKEN OFF THE DISTAL TIP OF THE INSTRUMENT. A TINY PIECE MEASURING APPROXIMATELY 1 MILLIMETER WAS LOCATED AND EXTRACTED FROM THE CHEST WALL. THE WOUND WAS INSPECTED WITH RETRACTORS LAYER BY LAYER, THEN THE CHEST WAS IRRIGATED AND PERISCAPULAR WOUNDS WITH SALINE. THE INSPECTION PROCESS WAS REPEATED, BUT NO PLASTIC WAS FOUND. THE FIELD WAS INSPECTED AS WELL. THE INCISION WAS THEN INSPECTED WITH A STERILE COVERED LINEAR ULTRASOUND PROBE, BUT THE USER COULD NOT IDENTIFY ANY OVERT CHEST WALL FOREIGN BODY. THE WOUND WAS RE-IRRIGATED AND THE CHEST WALL WAS INSPECTED LAYER BY LAYER WITH THE THORACOSCOPE. CONSIDERING THE RISKS ASSOCIATED WITH ADDITIONAL TIME UNDER ANESTHESIA, THE SURGEON PROCEEDED WITH THE COMPLETION OF THE OPERATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23671825 ↗
• MalfunctionJul 21, 2025Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THERE WAS A LOSS OF INSUFFLATION AND AN AIR OR GAS LEAK FROM THE SEAL WHILE THE CANNULA WAS IN THE PATIENT¿S ABDOMEN. DURING MANIPULATION, THE TOP PORTION OF THE CANNULA BROKE OFF FROM THE SHAFT. BOTH PIECES WERE REMOVED FROM THE SURGICAL FIELD AND COLLECTED. NO DEVICE COMPONENTS FELL INTO THE PATIENT CAVITY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22560307 ↗
• MalfunctionDec 30, 2019Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING APPENDECTOMY, THE TIP OF 12MM TROCAR CRACKED UPON ATTEMPT TO REMOVE APPENDIX THROUGH TROCAR. CRACKED PIECES REMAINED ATTACHED TO TROCAR.

  Patient problems: No Information

  MAUDE report 9532142 ↗
• InjuryAug 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, UPON REMOVAL OF SPECIMEN VIA 12MM TROCAR DURING A THYMECTOMY WITH VIDEO ASSISTED THORACOSCOPIC SURGERY, A PIECE OF PLASTIC FROM THE END OF THE TROCAR BROKE OFF. AN X-RAY WAS PERFORMED WITHOUT EVIDENCE. IT WAS STATED THAT FRAGMENT WAS RETAINED.

  Patient problems: Device Embedded In Tissue or Plaque; Radiation Exposure, Unintended

  MAUDE report 8877091 ↗
• InjuryMay 1, 2019Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPY PROCEDURE, A SMALL PIECE BROKE OFF OF TROCAR. A DEVICE COMPONENT FELL INTO THE CAVITY OF THE PATIENT AND WAS NOT RETRIEVED FOR IT COULD NOT BE LOCATED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8570258 ↗
• MalfunctionFeb 19, 2019Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING A HYSTERECTOMY ON A UTERINE MALIGNANCY, THE DEVICE WAS USED ON THE PATIENT, WHEN THEY ATTEMPTED TO INSERT THE REDUCER SLEEVE AS USUAL BUT NO MATTER HOW MANY TIMES THEY TRIED, IT DID NOT GO THROUGH. THEY ALSO OPENED A NEW PRODUCT AND INSERTED IT, BUT IT DID NOT GO THROUGH AS WELL. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8352476 ↗
• MalfunctionFeb 19, 2019Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING A HYSTERECTOMY ON A UTERINE MALIGNANCY, THE DEVICE WAS USED ON THE PATIENT, WHEN THEY ATTEMPTED TO INSERT THE REDUCER SLEEVE AS USUAL BUT NO MATTER HOW MANY TIMES THEY TRIED, IT DID NOT GO THROUGH. THEY ALSO OPENED A NEW PRODUCT AND INSERTED IT, BUT IT DID NOT GO THROUGH AS WELL. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8352473 ↗
• MalfunctionMar 16, 2018Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN INSERTING THE LAPAROSCOPIC STAPLER DOWN THE CANNULA, THE TROCAR/CANNULA CRACKED. IN ORDER TO RESOLVE THE ISSUE, THE TROCAR WAS REMOVED AND PLACED ANOTHER DEVICE IN ITS PLACE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7346489 ↗
• MalfunctionJan 29, 2018Difficult to Insert; Noise, Audible; Difficult to Insert; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, WHILE BEING APPLIED ON THE INITIAL ENTRY, THE SURGEON TRIED TO INSERT THE DEVICE INTO THE TROCAR BUT IT WOULD NOT GO THROUGH. IT ALSO MADE A STRANGE NOISE ON ALL PORTS. THEY OPENED A NEW TROCAR TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7226528 ↗