NanoPass CAT02298Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07613252633204), received between Oct 23, 2018 and May 14, 2026 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Material Fragmentation

  IT WAS REPORTED THAT THERE WAS A BROKEN NANOPASS TIP WHILE PASSING THROUGH LABRUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25173883 ↗
• MalfunctionMay 14, 2026Material Fragmentation

  IT WAS REPORTED THAT THERE WAS A BROKEN NANOPASS TIP WHILE PASSING THROUGH LABRUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25173877 ↗
• MalfunctionMar 5, 2026Fracture

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY SURGERY, THE SURGEON WAS GRABBING A SUTURE WHEN THE DEVICE¿S GRASPING MECHANISM BROKE OFF IN THE PATIENT, REQUIRING THE SURGEON TO RETRIEVE THE BROKEN PIECE OF THE PATIENT. THERE IS NO REPORTED SERIOUS HARM/ INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521412 ↗
• MalfunctionAug 7, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE NANOPASS CRESCENT SHEATH BROKE IN PATIENT. THE DOCTOR HAD TO FISH OUT BROKEN METAL IN PATIENT. IT WAS REPLACED WITH A NEW DISPOSABLE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22745208 ↗
• MalfunctionDec 11, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20907874 ↗
• MalfunctionApr 11, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN THE STERILE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19092894 ↗
• MalfunctionJan 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE JAW BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18460682 ↗
• MalfunctionNov 7, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING PROCEDURE THAT THE UPPER PART OF THE GRASPING JAW WAS MISSING. USING X-RAY IT WAS OBSERVED TO STILL BE IN THE JOINT. ATTEMPTS WERE MADE TO RETRIEVE IT, BUT RETRIEVAL WAS UNSUCCESSFUL. IT WAS LEFT IN THE JOINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18089018 ↗
• MalfunctionOct 4, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17873180 ↗
• MalfunctionJun 25, 2020Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE DEVICE BROKE OUTSIDE OF THE JOINT DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10198021 ↗
• MalfunctionJun 15, 2020Material Deformation; Material Deformation

  PER INVESTIGATION RESULTS, THE DEVICE WAS BROKEN AT THE INTERNAL SHAFT. PER ADDITIONAL INFORMATION RECEIVED, THE DEVICE BENT INSIDE THE JOINT AND WHEN REMOVED WAS ATTEMPTED TO BE STRAIGHTENED AND IT BROKE. NO PIECES BROKE INSIDE OF THE JOINT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10153914 ↗
• MalfunctionJun 15, 2020Material Deformation; Material Deformation

  PER INVESTIGATION RESULTS, THE DEVICE WAS BROKEN AT THE INTERNAL SHAFT. PER ADDITIONAL INFORMATION RECEIVED, THE DEVICE BENT INSIDE THE JOINT AND WHEN REMOVED WAS ATTEMPTED TO BE STRAIGHTENED AND IT BROKE. NO PIECES BROKE INSIDE OF THE JOINT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10153908 ↗
• InjuryDec 9, 2019Product Quality Problem; Product Quality Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A POTENTIAL FOR FOREIGN MATERIAL BEING LEFT IN THE JOINT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9438575 ↗
• MalfunctionSep 25, 2019Break

  IT WAS REPORTED THAT THE TIP BROKE DURING THE PROCEDURE. THE DEVICE BROKE OUTSIDE OF THE JOINT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9118395 ↗
• MalfunctionOct 23, 2018Break

  IT WAS REPORTED THAT THE TIP BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7996047 ↗