FMS 218019Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886705023721), received between Jan 14, 2019 and Mar 2, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2021, IT WAS OBSERVED THAT THE INNER INSERTER OF THE INFLOW/OUTFLOW SHEATH SYSTEM (SMITH & NEPHEW) DEVICE BROKE OFF. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 15 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11399780 ↗
• MalfunctionJul 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT THE O-RINGS OF THE INFLOW/OUTFLOW SHEATH SYSTEM KEEPS COMING OFF. NO PROCEDURE WAS INVOLVED AT THE TIME OF THE FAILURE. THE DEVICES ARE AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10311771 ↗
• MalfunctionJul 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT THE O-RINGS OF THE INFLOW/OUTFLOW SHEATH SYSTEM KEEPS COMING OFF. NO PROCEDURE WAS INVOLVED AT THE TIME OF THE FAILURE. THE DEVICES ARE AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10311766 ↗
• MalfunctionJun 30, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER SCOPE THE INFLOW/OUTFLOW SHEATH SYSTEM (B)(4) WAS LEAKING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10212115 ↗
• MalfunctionNov 13, 2019Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE LEVERS ON THE CUSTOMER'S INFLOW/OUTFLOW SHEATH SYSTEM BROKE OFF FOR THE INFLOW/OUTFLOW AND THE O-RING ON THE DEVICE IS DAMAGED. THE SALES REP STATED THAT THE DEVICE DID NOT BREAK IN THE PATIENT AND NO DEBRIS IN PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO PATIENT HARM BUT THERE WAS A FIVE MINUTE SURGICAL DELAY TO THE CASE. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 9318849 ↗
• MalfunctionSep 11, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CUSTOMER'S FMS INFLOW OUTFLOW SHEATH KIT WAS LEAKING PRIOR TO A ROTATOR CUFF REPAIR WHILE SETTING UP FOR THE CASE. THE CASE WAS COMPLETED USING ANOTHER LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE DEVICE IS BEING RETURNED. THIS REPORT IS FOR A FMS INFLOW OUTFLOW SHEATH KIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8988834 ↗
• MalfunctionJan 14, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE CUSTOMER'S INFLOW/OUTFLOW SHEATH SYSTEM ((B)(6)) OUTFLOW CONTROL LEVER BROKE OFF THE DEVICE. THE SALES REP DID NOT KNOW IF ANY EXCESSIVE FORCE WAS BEING USED TO MOVE THE LEVER. THE CASE WAS COMPLETED WITH ANOTHER LIKE-DEVICE WITH NO PATIENT HARM OR DELAY. THE SALES REP WAS NOT PRESENT AND COULD NOT PROVIDE ANY ADDITIONAL INFORMATION. THE DEVICE IS BEING RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8243715 ↗