StepRecalls & reported problems across all models
Covidien LP · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Step model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 48
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 1
We found 10 models of Step by Covidien LP in the FDA's device registry (GUDID). Together they are named in 48 adverse event reports in the FDA's MAUDE database, received between Sep 27, 2017 and Mar 31, 2026 — classified as 5 injuries, 43 malfunctions.
The most frequently reported specific device problem is “Break” (33 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Reports received per month, all models
Step recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 1, 2023Open, Classified
Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the eye, pose a loss of vision risk.
Z-1387-2023 · Root cause: Process control · Recall details · FDA record ↗
Most reported Step problems
Device problems
- Break33
- Detachment of Device or Device Component23
- Packaging Problem7
- Difficult to Insert4
- Noise, Audible3
- Adverse Event Without Identified Device or Use Problem2
- Difficult to Remove2
- Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- No Consequences Or Impact To Patient13
- No Known Impact Or Consequence To Patient6
- Foreign Body In Patient5
- Insufficient Information3
- No Code Available3
- Tissue Breakdown2
- Device Embedded In Tissue or Plaque1
Step models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Step S101010Laparoscope, general & plastic surgery1 recall1 report
- Step S100712Laparoscope, general & plastic surgery18 reports
- Step S100000Laparoscope, general & plastic surgery10 reports
- Step S110000Laparoscope, general & plastic surgery7 reports
- Step S100705Laparoscope, general & plastic surgery4 reports
- Step S100710Laparoscope, general & plastic surgery4 reports
- Step S100700Laparoscope, general & plastic surgery1 report
- Step S101000Laparoscope, general & plastic surgery1 report
- Step S101005Laparoscope, general & plastic surgery1 report
- Step S101012Laparoscope, general & plastic surgery1 report
Recent Step adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2026Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Noise, Audible
IT WAS REPORTED THAT DURING THE START OF A ROBOTIC LAPAROSCOPIC VENTRAL HERNIA REPAIR WHILE BEING USED TO INSUFFLATE THE ABDOMEN, THE INSUFFLATION NEEDLE WENT INTO THE MESENTERY AND INSUFFLATED IT A LITTLE. TISSUE DAMAGE WAS OBSERVED. THE SURGEON ALLEGED THAT THE NEEDLE DID NOT MAKE A SOUND WHEN ENTERING THE PATIENT, AND THAT THIS LACK OF AUDIBLE SOUND CAUSED THE NEEDLE TO BE INSERTED TOO FAR, WITH MESENTERIC INSUFFLATION OCCURRING. THE CASE WAS REPORTED TO HAVE CONTINUED, AND NO ADDITIONAL OPERATION WAS PLANNED.
Patient problems: Tissue Breakdown
MAUDE report 24746819 ↗MalfunctionDec 25, 2025Break; Break
IT WAS REPORTED THAT PREOPERATIVELY OF LAPAROSCOPIC GASTROPEXY, THE JAWS OF THE TWO CLIP APPLIERS WOULD NOT OPEN ALL THE WAY AND WOULD NOT FIRE. ADDITIONALLY, THE CANNULA BROKE FOR BOTH THE PORTS. THE DEVICE WAS NOT USED ON THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23892194 ↗MalfunctionJan 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE INVOLVING THE DEVICE, THE SHEATH OF THE TROCAR RIPPED, AND A PIECE FELL OFF INTO THE PATIENT. TO RESOLVE THE ISSUE, THE BROKEN PIECE OF THE SHEATH WAS RETRIEVED FROM THE PATIENT'S CAVITY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21093519 ↗MalfunctionDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING A PROCEDURE FOR ACUTE APPENDICITIS, WHILE INSERTING THE LAPAROSCOPIC PORTS, THE SHORT VERESS NEEDLE HAD BEEN REPLACED WITH A SUBSTITUTION NEEDLE THAT WAS LONGER THAN WHAT WAS NORMALLY USED. THE NEEDLE HIT THE PATIENT'S INNER ABDOMEN AND CAUSED AN INTRAMURAL HEMATOMA OF THE SIGMOID COLON. AFTER REPAIRING, THE COLON WAS INSPECTED DIRECTLY; THERE WAS NO FULL-THICKNESS INJURY. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED FOR 30 MINUTES.
Patient problems: Hematoma
MAUDE report 20919450 ↗MalfunctionSep 11, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN USED TO BE CONNECTED TO INSUFFLATION TUBING, THE SMALL BLUE PIECE BROKE WHEN USING THE TROCAR. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20195365 ↗MalfunctionSep 11, 2024Break; Break
ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN OPENING THE PACKAGE, THE USER FOUND OUT THAT THE STOPCOCK DETACHED FROM THE TOP PORTION OF THE PORT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20191712 ↗MalfunctionDec 18, 2023Break; Break
ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN PACKAGED OPENED, NEEDLE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18346278 ↗MalfunctionDec 11, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN THE SURGEON PLACED THE TROCAR INTO THE PATIENT, A PIECE OF PLASTIC FROM THE TROCAR BROKE OFF AND FELL INTO THE PATIENT'S CAVITY. THE SURGEON RETRIEVED THE PLASTIC PIECE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18304981 ↗MalfunctionNov 10, 2023Break; Break
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A VIDEO-ASSISTED THORACOSCOPIC SURGERY WITH LEFT APICAL WEDGE RESECTION, APICAL PLEURECTOMY, AND SIDEWALL PLEURODESIS, THE TIP OF THE TROCAR CRACKED AND BROKE OFF INSIDE THE PATIENT. THE STAFF IN THE ROOM WAS THINKING THAT THE LAPAROSCOPIC STAPLER USED MAY HAVE CAUSED THE INITIAL DAMAGE TO THE TROCAR AND CREATED A CRACK OR WEAK SPOT TOWARDS THE TIP OF THE TROCAR. THE STAPLER DEVICE WAS NOT BROUGHT BACK INTO ALIGNMENT WITH THE SHAFT BEFORE TRYING TO BE WITHDRAWN THROUGH THE TROCAR. A COUPLE OF ATTEMPTS TO BRING THE STAPLER OUT WERE DONE WITH RESISTANCE BEFORE IT WAS REALIZED THE JAW OF THE STAPLER WAS STILL COCKED AT AN ANGLE. ONCE THE STAPLER WAS STRAIGHTENED OUT AND REMOVED A LAPAROSCOPIC INSTRUMENT WITH AN ELECTROSURGERY DEVICE SCRATCH PAD WRAPPED AROUND THE TIP AND PLACED INTO THE TROCAR. THE INSTRUMENT WAS THEN PASSED THROUGH THE TROCAR WITH EASE, AND IT WAS DISCOVERED THAT THE TIP OF THE TROCAR WAS BROKEN, DANGLING AROUND THE SHAFT OF THE INSTRUMENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18115875 ↗MalfunctionSep 14, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GYNECOLOGIC PROCEDURE, WHEN UNPLUGGING THE PORT, THE CANNULA OF THE DEVICE RUPTURED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17745620 ↗MalfunctionSep 8, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) WITH APICAL LUNG RESECTION AND PLEURODESIS, WHILE THE STAPLER WAS DOWN ON THE TROCAR, WHEN THE SURGEON PULLED OUT THE STAPLER, THE TROCAR BROKE INSIDE AND FELL INTO THE PATIENT'S CAVITY. THE SURGEON WAS ABLE TO RETRIEVE THE TROCAR PART THAT FELL. IT WAS ALSO REPORTED THAT THERE WAS MINIMAL TISSUE DAMAGE DUE TO THE ISSUE. THE INCISION WAS EXTENDED DUE TO THE ISSUE. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE.
Patient problems: Tissue Breakdown
MAUDE report 17715746 ↗MalfunctionMar 16, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SPRING WAS BROKEN. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16551958 ↗MalfunctionJan 4, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE STOPCOCK BROKE. THE TOP FELL OFF OF THE INSUFFLATION NEEDLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16094422 ↗MalfunctionDec 7, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE TIP OF THE TWO EXPANDABLE SLEEVES RIPPED OFF AND SEPARATED FROM THE PLASTIC PART. THE PIECES HAD TO BE RETRIEVED AND REMOVED FROM ABDOMEN. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15933845 ↗MalfunctionDec 7, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE TIP OF THE TWO EXPANDABLE SLEEVES RIPPED OFF AND SEPARATED FROM THE PLASTIC PART. THE PIECES HAD TO BE RETRIEVED AND REMOVED FROM ABDOMEN. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15933797 ↗
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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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