FMS 218023Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705023738), received between Sep 26, 2019 and Oct 18, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2021Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT DURING REPROCESSING, IT WAS OBSERVED THAT THE BLUE KNOB ON THE SIDE OF THE I/O FLOW SHEATH-STORZ DEVICE BROKE OFF. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12651136 ↗
• MalfunctionSep 26, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THIS IS REPORT 2 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING SHOULDER ARTHROSCOPY, IT WAS OBSERVED THAT THREE I/O FLOW SHEATH-STORZ DEVICES WERE LEAKY EVEN THOUGH THEY CHANGED THE O-RINGS. THERE WAS A THREE-MINUTE DELAY IN THE SURGICAL PROCEDURE. THERE WAS A COMPETITOR 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: Not Applicable

  MAUDE report 9122462 ↗
• MalfunctionSep 26, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THIS IS REPORT 3 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING SHOULDER ARTHROSCOPY, IT WAS OBSERVED THAT THREE I/O FLOW SHEATH-STORZ DEVICES WERE LEAKY EVEN THOUGH THEY CHANGED THE O-RINGS. THERE WAS A THREE-MINUTE DELAY IN THE SURGICAL PROCEDURE. THERE WAS A COMPETITOR 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: Not Applicable

  MAUDE report 9122461 ↗
• MalfunctionSep 26, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THIS IS REPORT 1 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING SHOULDER ARTHROSCOPY, IT WAS OBSERVED THAT THREE I/O FLOW SHEATH-STORZ DEVICES WERE LEAKY EVEN THOUGH THEY CHANGED THE O-RINGS. THERE WAS A THREE-MINUTE DELAY IN THE SURGICAL PROCEDURE. THERE WAS A COMPETITOR 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: Not Applicable

  MAUDE report 9122460 ↗