FMS 218021Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705023745), received between Sep 13, 2019 and Sep 26, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2019Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER REPAIR PROCEDURE THE SALES REP'S INFLOW/OUTFLOW SHEATH SYSTEM (STRYKER) WAS LEAKING WATER AROUND THE O-RINGS. THE CASE WAS COMPLETED WITH A COMPETITOR'S DEVICE WITH NO PATIENT HARM OR DELAY. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9124798 ↗
• MalfunctionSep 13, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE SALES REP THE DURING A SHOULDER PROCEDURE THE O-RINGS ON THE CUSTOMER'S INFLOW/OUTFLOW SHEATH KIT STRYKER ARE WEAK AND CAUSING THE DEVICE TO LEAK. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO HARM TO THE PATIENT OR DELAYS TO THE CASE. THE SALES REP STATED THAT THE DEVICE WAS DISCARDED BY THE CUSTOMER. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9039850 ↗