SlingShot CAT02589Recalls & reported problems
Stryker Corporation · SLINGSHOT 45 UP · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252656609), received between Sep 14, 2020 and Jan 11, 2024 — classified as 3 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 Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 11, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE JAW OF THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18499680 ↗MalfunctionOct 13, 2020Break
IT WAS REPORTED THAT THE BOTTOM JAW OF THE DEVICE BROKE. THE BROKEN PIECE WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10672007 ↗MalfunctionSep 14, 2020Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE, HOWEVER NO PIECES FELL INTO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10530806 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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