NanoPass CAT01356Recalls & reported problems
Stryker Corporation · NANOPASS REACH 45 RIGHT · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252632955), received between Nov 10, 2025 and Nov 10, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Reports received per month
Most reported problems
Device problems
- Break2
- Material Fragmentation2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 10, 2025Break; Material Fragmentation; Break; Material Fragmentation
IT WAS REPORTED THAT DURING THE TIP BROKE. THE BROKEN PIECES WERE NOT LEFT IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23517077 ↗MalfunctionNov 10, 2025Break; Material Fragmentation; Break; Material Fragmentation
IT WAS REPORTED THAT DURING THE TIP BROKE. THE BROKEN PIECES WERE NOT LEFT IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23517076 ↗
Other PASSER devices
- NA 7209485Smith & Nephew, Inc. · PASSER202 reports
- FIRSTPASS 22-4038Smith & Nephew, Inc. · PASSER189 reports
- FIRSTPASS 22-4035Smith & Nephew, Inc. · PASSER67 reports
- NanoPass CAT02298Stryker Corporation · PASSER15 reports
- NA 7210752Smith & Nephew, Inc. · PASSER13 reports
- ENDOBUTTON 014396Smith & Nephew, Inc. · PASSER10 reports
- SlingShot CAT02590Stryker Corporation · PASSER8 reports
- Champion SlingShot CAT02855Stryker Corporation · PASSER5 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.