Endopath PN150Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705036012979), received between Dec 17, 2019 and Apr 3, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE NEEDLE DOES NOT SPRING BACK WHEN PULLED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781953 ↗
• MalfunctionJan 23, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT THE PACKAGE RECEIVED WAS NONSTERILE; THE ENTIRE LOT APPEARED CONTAMINATED AND EVERY SINGLE THING HAS WHITE PARTICLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24166777 ↗
• MalfunctionMar 25, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, NEEDLE DOES NOT SPRING BACK WHEN PULLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21688885 ↗
• MalfunctionSep 10, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A LAP BSO PROCEDURE, NOTICED THAT THE RED INDICATOR WAS IN THE STUCK ¿UP¿ POSITION, EVEN WHEN REMOVED FROM ABDOMINAL WALL. REPLACED WITH ANOTHER DEVICE TO COMPLETE PROCEDURE. SURGERY WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF FIVE MINUTES. THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20180555 ↗
• MalfunctionSep 10, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A LAP BSO PROCEDURE, NOTICED THAT THE RED INDICATOR WAS IN THE STUCK ¿UP¿ POSITION, EVEN WHEN REMOVED FROM ABDOMINAL WALL. REPLACED WITH ANOTHER DEVICE TO COMPLETE PROCEDURE. SURGERY WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF FIVE MINUTES. THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20180547 ↗
• MalfunctionSep 10, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A LAP BSO PROCEDURE, NOTICED THAT THE RED INDICATOR WAS IN THE STUCK ¿UP¿ POSITION, EVEN WHEN REMOVED FROM ABDOMINAL WALL. REPLACED WITH ANOTHER DEVICE TO COMPLETE PROCEDURE. SURGERY WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF FIVE MINUTES. THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20180536 ↗
• MalfunctionAug 30, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PN150'S RED SAFETY CAP HAD SLID DOWN THE PRODUCT AND WAS STUCK WHEN NURSES OPENED THE PRODUCT. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17652480 ↗
• MalfunctionJul 13, 2023Delivered as Unsterile Product; Difficult to Open or Remove Packaging Material; Delivered as Unsterile Product; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE TWO OF THE DEVICES' TYVEK PACKAGING FLAKED WHEN PEELED AND FELL ONTO THE TABLE RAISING STERILITY CONCERNS. A NEW DEVICE FROM A DIFFERENT LOT WAS OPENED WITH NO ISSUES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17320700 ↗
• MalfunctionJul 13, 2023Delivered as Unsterile Product; Difficult to Open or Remove Packaging Material; Delivered as Unsterile Product; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE TWO OF THE DEVICES' TYVEK PACKAGING FLAKED WHEN PEELED AND FELL ONTO THE TABLE RAISING STERILITY CONCERNS. A NEW DEVICE FROM A DIFFERENT LOT WAS OPENED WITH NO ISSUES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17319808 ↗
• MalfunctionOct 27, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TOP OF THE DEVICE DOES NOT BOUNCE BACK WHEN USED. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15683809 ↗
• MalfunctionMay 9, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE NEEDLE OF PN150 PENETRATED THE PACKAGE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14337624 ↗
• MalfunctionSep 8, 2020Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE PRODUCT WAS OPENED THE WHITE PACKAGING WAS DISINTEGRATING. IT COMPROMISED STERILITY. IT IS UNKNOWN IF ANY PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10505739 ↗
• MalfunctionAug 24, 2020Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PACKAGE WAS FALLING APART AND DEGRADING AS IT WAS OPENED, COMPROMISING THE DEVICE STERILITY. THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10444481 ↗
• MalfunctionDec 17, 2019Material Disintegration

  IT WAS REPORTED THAT PRIOR TO AN UNKNOWN PROCEDURE, THE PACKAGING SHOWED SIGNS OF DISINTEGRATION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9485420 ↗