VersaStep Plus VS101011PRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10884521082878), received between Oct 5, 2017 and Jul 31, 2025 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2025Break; Break

  IT WAS REPORTED THAT DURING USE OF THE PORT, THE KNIFE WAS DIFFICULT TO ADVANCE, THE SLEEVE DID NOT EXPAND AND THE SLEEVE RUPTURED IN THE MIDDLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22680065 ↗
• MalfunctionJul 24, 2025Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT DURING TROCAR PLACEMENT IN A LAPAROSCOPIC PROCEDURE, THE CANNULA COULD NOT BE PLACED THROUGH THE RADIAL SLEEVE. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE WITH ANOTHER TROCAR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22585919 ↗
• MalfunctionMar 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT, THE DEVICE HAD A DAMAGED SEAL.

  Patient problems: Insufficient Information

  MAUDE report 21649020 ↗
• MalfunctionNov 4, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC CHOLECYSTECTOMY, WHILE ON PREPARATION STAGE, THE EXPANDABLE SLEEVE OF THE CANNULA WAS BROKEN IN THE MIDDLE AND THE USED WAS DISCONTINUED. IT WAS NOTED THAT A PROBLEM HAD OCCURRED ON THE CONNECTION BETWEEN THE ACCESS NEEDLE AND THE EXPANDABLE SLEEVE. THE CANNULA WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20600216 ↗
• MalfunctionSep 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, AT THE BEGINNING OF THE PROCEDURE, THE RUBBER PIECE CAME OFF FROM TROCAR TOP. NO DEVICE COMPONENT FELL INTO THE CAVITY OF THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20224127 ↗
• MalfunctionNov 9, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE RADIAL EXPANDABLE SLEEVE UNRAVELED AT THE DISTAL END. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12779415 ↗
• MalfunctionJun 14, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, ONCE THE LAPAROSCOPIC RIGHT NEPHRECTOMY WAS COMPLETED, THE STEP PORT WAS REMOVED AND AFTER A FEW MINUTES THE MOMENTUM PROTRUDED THROUGH THE PORT SITE. FASCIAL CLOSURE AS WELL AS SUBMUCOSA AND SKIN CLOSURE WAS NEEDED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11996855 ↗
• MalfunctionNov 5, 2020Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE CANNULA BROKE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10795966 ↗
• MalfunctionSep 4, 2020Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC OOPHORECTOMY AND SALPHINGECTOMY, THE CANNULA AND THE BLUNT DILATOR OF THE PORT COULD NOT PENETRATE THE MESH. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10494282 ↗
• MalfunctionJul 16, 2020Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN FINISHING THE PROCEDURE AND REMOVING THE TROCARS AT THE END OF THE PROCEDURE, THE SURGEON NOTICED THAT THE SEAL WAS DAMAGED AND FELL INTO THE PATIENT'S CAVITY. THE SEAL WAS REMOVED LAPAROSCOPICALLY AND FINISHED THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10283371 ↗
• MalfunctionAug 9, 2019Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE OBTURATOR BROKE WHILE INSERTING THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8881071 ↗
• MalfunctionSep 7, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A LAPARO GYN, WHEN PIERCING THE ABDOMINAL WALL, THE TIP OF THE ACCESS NEEDLE BENT. ALSO, THE COVERING THE MESH PART OF THE EXPANDABLE SLEEVE WAS DETACHED AND DROPPED INTO THE ABDOMINAL CAVITY, BUT WAS SUBSEQUENTLY RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7856342 ↗
• InjurySep 5, 2018Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCEDURE, PIECE OF UNKNOWN DEVICE IN USE WAS BROKEN OFF AND RETAINED DURING SURGERY. THERE WAS ALLEGED ABSCESS AND LENGTHENED SICKNESS OF THE PATIENT REPORTED.

  Patient problems: Abscess

  MAUDE report 7846203 ↗
• MalfunctionJul 24, 2018Break

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE CANNULA OF THE DEVICE BROKE. A NEW DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 7715134 ↗
• MalfunctionMar 29, 2018Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING LAPAROSCOPIC EXCISION OF LESION OF UTERUS, THE PLASTIC PART OF THE EXPANDABLE SLEEVE WAS FOUND TO BE PEELED AND FRAYED. THE FIBER SEEMED TO BE EXPOSED. TO COMPLETE THE CASE, THEY DID NOTHING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7381487 ↗
• MalfunctionJan 5, 2018Leak/Splash; Device Packaging Compromised; Leak/Splash; Device Packaging Compromised

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC OOPHORECTOMY AND SALPINGECTOMY PROCEDURE, PNEUMOPERITONEUM LEAKAGE OCCURRED. THE AIR LEAKED BECAUSE THE UPPER SEAL OF THE DEVICE COULD NOT BE CLOSED COMPLETELY. THE SURGEON USED FORCEPS THROUGH THE TROCAR, BUT AIR LEAKED. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7167567 ↗
• MalfunctionOct 5, 2017Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, THE TIP CAME OUT OF THE DEVICE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6915374 ↗