SlingShot CAT02590Recalls & reported problems
Stryker Corporation · SLINGSHOT 70 UP · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613252656616), received between Jun 18, 2019 and Aug 7, 2025 — classified as 1 injury, 7 malfunctions.
The most frequently reported specific device problem is “Break” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break6
- Material Fragmentation2
- Adverse Event Without Identified Device or Use Problem1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Foreign Body In Patient2
- Device Embedded In Tissue or Plaque1
- Insufficient Information1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE SLINGSHOT 70 DEGREE PASSER 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 22745293 ↗MalfunctionApr 15, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE SLINGSHOT BOTTOM JAW BROKE WHILE PASSING SUTURE THROUGH CAPSULE. THE BROKEN PIECE WAS LEFT INSIDE THE PATIENTS CAPSULE.
Patient problems: Foreign Body In Patient
MAUDE report 21842647 ↗MalfunctionMay 17, 2023Break; Break
IT WAS REPORTED THAT PIECE OF THE DEVICE BROKE OFF DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16947379 ↗MalfunctionFeb 28, 2023Break
IT WAS REPORTED THAT THE JAW OF THE DEVICE BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 16455942 ↗MalfunctionJun 20, 2022Break
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 14745857 ↗MalfunctionOct 8, 2020Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE INNER SHEATH BROKE OFF INTO THE PATIENT DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 10653191 ↗InjuryFeb 10, 2020Break; Adverse Event Without Identified Device or Use Problem; Break
IT WAS REPORTED THAT A PIECE OF THE DEVICE WAS LEFT IN THE JOINT.
Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient
MAUDE report 9687519 ↗MalfunctionJun 18, 2019Break
IT WAS REPORTED THAT THE TIP BROKE DURING PROCEDURE. THE TIP WAS RETRIEVED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8708614 ↗
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
- NA 014395Smith & Nephew, Inc. · PASSER5 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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