FLEXIPATHRecalls & reported problems across all models

We found 2 models of FLEXIPATH by Ethicon Endo-Surgery, LLC in the FDA's device registry (GUDID). Together they are named in 42 adverse event reports in the FDA's MAUDE database, received between Nov 7, 2018 and Jan 8, 2026 — classified as 2 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (14 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 FLEXIPATH problems

FLEXIPATH models

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

• FLEXIPATH FP015

  Laparoscope, general & plastic surgery
  40 reports
• FLEXIPATH FP007

  Laparoscope, general & plastic surgery
  2 reports

Recent FLEXIPATH adverse event reports

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

• MalfunctionJan 8, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, WHILE USING FLEXIPATH SURGICAL TROCAR - THEY PACKAGING ON THE OUTSIDE SAYS IT IS SUPPOSED TO BE 15MM IN LENGTH, BUT UPON OPENING THE CAP IS CLEARLY MARKED AS BEING 20MM. NO PATIENT HARM, JUST GRABBED A TROCAR PACKAGE WITH A DIFFERENT LOT NUMBER. THE PROCEDURE WAS DELAYED BY 10-20 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24002362 ↗
• MalfunctionDec 20, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE VATS PROCEDURE, THE TROCAR DID NOT FIT THE SLEEVE. THEY WERE 15 MILLIMETER TROCARS. THE BLACK SLEEVE IS A 20 MILLIMETER. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18368436 ↗
• MalfunctionDec 20, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE VATS PROCEDURE, THE TROCAR DID NOT FIT THE SLEEVE. THEY WERE 15 MILLIMETER TROCARS. THE BLACK SLEEVE IS A 20 MILLIMETER. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18368031 ↗
• MalfunctionDec 20, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE VATS PROCEDURE, THE TROCAR DID NOT FIT THE SLEEVE. THEY WERE 15 MILLIMETER TROCARS. THE BLACK SLEEVE IS A 20 MILLIMETER. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367964 ↗
• MalfunctionDec 20, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE VATS PROCEDURE, THE TROCAR DID NOT FIT THE SLEEVE. THEY WERE 15 MILLIMETER TROCARS. THE BLACK SLEEVE IS A 20 MILLIMETER. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367945 ↗
• MalfunctionDec 20, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE VATS PROCEDURE, THE TROCAR DID NOT FIT THE SLEEVE. THEY WERE 15 MILLIMETER TROCARS. THE BLACK SLEEVE IS A 20 MILLIMETER. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367846 ↗
• MalfunctionDec 20, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE VATS PROCEDURE, THE TROCAR DID NOT FIT THE SLEEVE. THEY WERE 15 MILLIMETER TROCARS. THE BLACK SLEEVE IS A 20 MILLIMETER. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367788 ↗
• MalfunctionDec 20, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE VATS PROCEDURE, THE TROCAR DID NOT FIT THE SLEEVE. THEY WERE 15 MILLIMETER TROCARS. THE BLACK SLEEVE IS A 20 MILLIMETER. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367588 ↗
• MalfunctionDec 20, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE VATS PROCEDURE, THE TROCAR DID NOT FIT THE SLEEVE. THEY WERE 15 MILLIMETER TROCARS. THE BLACK SLEEVE IS A 20 MILLIMETER. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367581 ↗
• MalfunctionDec 8, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A VATS PROCEDURE, THE TROCAR DID NOT FIT THE SLEEVE. THEY WERE 15 MILLIMETER TROCARS. THE BLACK SLEEVE IS A 20 MILLIMETER. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18295045 ↗
• MalfunctionNov 21, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A LUNG PROCEDURE IT WAS NOTICED THE BLACK SLEEVE IS 20 MILLILITERS WHICH IS TOO BIG. AFTER OPENING UP A COUPLE THEY ENDED UP JUST USING THE LARGER DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18185172 ↗
• MalfunctionNov 21, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A VATS PROCEDURE, THE TROCAR DID NOT FIT THE SLEEVE. THEY WERE 15 MILLIMETER TROCARS. THE BLACK SLEEVE IS A 20 MILLIMETER. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18182938 ↗
• MalfunctionOct 19, 2023Gas/Air Leak; Appropriate Device Problem Term/Code Not Available; Gas/Air Leak; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A THORACOSCOPY, THE OBTURATOR WAS NOT "EXPANDING" ENOUGH TO HOLD THE BLACK SLEEVE CAUSING A LOSS OF GAS FROM THE PATIENT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17967554 ↗
• MalfunctionOct 19, 2023Gas/Air Leak; Appropriate Device Problem Term/Code Not Available; Gas/Air Leak; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A THORACOSCOPY, THE OBTURATOR WAS NOT "EXPANDING" ENOUGH TO HOLD THE BLACK SLEEVE CAUSING A LOSS OF GAS FROM THE PATIENT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17967206 ↗
• MalfunctionOct 19, 2023Gas/Air Leak; Appropriate Device Problem Term/Code Not Available; Gas/Air Leak; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A THORACOSCOPY, THE OBTURATOR WAS NOT "EXPANDING" ENOUGH TO HOLD THE BLACK SLEEVE CAUSING A LOSS OF GAS FROM THE PATIENT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17967166 ↗

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