FLEXIPATH FP015Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10705036011910), received between Nov 7, 2018 and Jan 8, 2026 — classified as 2 injuries, 38 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, 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 25 most recent of 40 reports, 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 ↗
• 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 17967118 ↗
• MalfunctionOct 12, 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 PROCEDURE, 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 17923700 ↗
• MalfunctionAug 24, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A 15MM TROCAR WAS MARKED AS 15MM BUT THE SLEEVE WAS MARKED AS 20 MM. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17612594 ↗
• MalfunctionAug 24, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A 15MM TROCAR WAS MARKED AS 15MM BUT THE SLEEVE WAS MARKED AS 20 MM. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17612578 ↗
• MalfunctionAug 24, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A 15MM TROCAR WAS MARKED AS 15MM BUT THE SLEEVE WAS MARKED AS 20 MM. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17612562 ↗
• MalfunctionAug 24, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A 15MM TROCAR WAS MARKED AS 15MM BUT THE SLEEVE WAS MARKED AS 20 MM. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17612542 ↗
• MalfunctionAug 24, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A 15MM TROCAR WAS MARKED AS 15MM BUT THE SLEEVE WAS MARKED AS 20 MM. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17612517 ↗
• MalfunctionAug 24, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A 15MM TROCAR WAS MARKED AS 15MM BUT THE SLEEVE WAS MARKED AS 20 MM. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17612469 ↗
• MalfunctionAug 24, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A 15MM TROCAR WAS MARKED AS 15MM BUT THE SLEEVE WAS MARKED AS 20 MM. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17612402 ↗
• MalfunctionAug 24, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A 15MM TROCAR WAS MARKED AS 15MM BUT THE SLEEVE WAS MARKED AS 20 MM. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17612374 ↗