VersaStep PlusRecalls & reported problems across all models

We found 7 models of VersaStep Plus by Covidien LP in the FDA's device registry (GUDID). Together they are named in 137 adverse event reports in the FDA's MAUDE database, received between Jun 2, 2017 and Sep 15, 2026 — classified as 19 injuries, 118 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (56 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported VersaStep Plus problems

VersaStep Plus models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• VersaStep Plus VS101015P

  Laparoscope, general & plastic surgery
  53 reports
• VersaStep Plus VS101012P

  Laparoscope, general & plastic surgery
  49 reports
• VersaStep Plus VS101011P

  Laparoscope, general & plastic surgery
  17 reports
• VersaStep Plus VS100712P

  Laparoscope, general & plastic surgery
  9 reports
• VersaStep Plus VS101512P

  Laparoscope, general & plastic surgery
  6 reports
• VersaStep Plus VSR100812P

  Laparoscope, general & plastic surgery
  2 reports
• VersaStep Plus VSR107812P

  Laparoscope, general & plastic surgery
  1 report

Recent VersaStep Plus adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Break

  It was reported that during a procedure, the mesh of the trocar cannula was broken. There was no patient injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766497 ↗
• MalfunctionMar 30, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, A PIECE OF THE TROCAR BROKE INSIDE THE PATIENT. THE TROCAR PIECE WAS RETAINED IN THE PATIENT AND SUBSEQUENTLY RETRIEVED DURING THE PROCEDURE. VISUALIZATION WAS USED TO IDENTIFY AND RETRIEVE THE BROKEN TROCAR PIECE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24712536 ↗
• InjuryMar 19, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC BARIATRIC SINGLE ANASTOMOSIS DUODENO-ILEAL BYPASS (SADI), TOWARDS THE END OF THE CASE, THE DISTAL PIECE AT THE END OF THE TROCAR WAS FOUND BROKEN OFF. A THOROUGH EXPLORATORY LAPAROSCOPY WAS PERFORMED BUT THE SURGEON WAS UNABLE TO LOCATE THE BROKEN PIECE. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM.

  Patient problems: Foreign Body In Patient; Laceration(s); Tissue Breakdown

  MAUDE report 24640632 ↗
• 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 ↗
• MalfunctionSep 3, 2025Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY LAPAROSCOPIC PROCEDURE, AT THE INSTRUMENT EXCHANGE STEP, THE DEVICE WAS FOUND TO BE EXCESSIVELY LEAKING GAS AND HAD A DAMAGED SEAL. ANOTHER TROCAR WAS OPENED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952483 ↗
• 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 28, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT PRE-OPERATIVELY, THE SEAL OF THE DEVICE WAS DAMAGED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22629227 ↗
• 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 ↗
• 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 ↗
• MalfunctionJul 7, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE EXPANDABLE SLEEVE BROKE AFTER THE ACCESS NEEDLE WAS INSERTED AND THE CANNULA WAS PLACED, RENDERING THE DEVICE UNUSABLE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE, AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412209 ↗
• InjuryMar 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC 3-HOLE ESOPHAGECTOMY USING THE DEVICE, PART OF THE CANNULA BROKE OFF AND FELL INTO THE PATIENT WHILE MOBILIZING THE CONDUIT. AN X-RAY WAS PERFORMED TO LOCATE THE COMPONENT, BUT THE PIECE OF THE TROCAR CANNULA WAS LEFT IN THE PATIENT. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO UNANTICIPATED TISSUE LOSS, TISSUE DAMAGE, SIGNIFICANT BLOOD LOSS, OR EXTENSION OF SURGICAL TIME OR INCISION DUE TO THE PRODUCT PROBLEM. THE PROCEDURE WAS CONTINUED AFTER THE X-RAYS WERE TAKEN, AND NO ADDITIONAL OPERATION WAS PLANNED TO CORRECT THE ISSUE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 21694399 ↗
• 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 ↗
• MalfunctionOct 9, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC RESECTION OF A TUMOR OF THE UTERINE ADNEXA, THE CANNULA RUPTURED. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409785 ↗
• MalfunctionSep 20, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY TO ROUX-EN-Y CONVERSION, THE RADIALLY EXPANDABLE SLEEVE TORE AND WAS STUCK ON THE END OF THE TROCAR. IT SEEMED AS THOUGH THERE WAS NO HOLE MADE IN THE TIP OF THE RADIALLY EXPANDABLE SLEEVE. THE SURGEON HAD TO USE TROCAR WITHOUT THE SLEEVE IN ORDER TO USE GRASPERS AND DEVICES IN THAT TROCAR SITE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20267390 ↗

Other Covidien LP products

• Endo GIA48 models · 26,277 reports · 8 recalls
• Endo GIA Ultra3 models · 15,650 reports
• Shiley387 models · 9,392 reports · 5 recalls
• Signia16 models · 8,201 reports · 6 recalls
• LigaSure32 models · 7,283 reports · 1 recall
• Tri-Staple 2.037 models · 4,892 reports · 2 recalls
• Polysorb291 models · 4,564 reports · 2 recalls
• EEA39 models · 4,432 reports · 1 recall