Check-Flo G08955Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002089556), received between Aug 8, 2017 and Dec 9, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Bent” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2020Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, DURING RETRIEVAL OF A COOK CELECT VENA CAVA FILTER VIA JUGULAR APPROACH, A PERFORMER INTRODUCER DEVELOPED HOLES IN THE MATERIAL. THE USER ATTEMPTED TO INSERT THE DEVICE WITH THE DILATOR IN PLACE; HOWEVER, THE SHEATH ACCORDION DURING INSERTION AS THE USER PUSHED "AS USUAL". AS THE DEVICE WAS REMOVED, SMALL HOLES WERE OBSERVED ON THE SIDE OF THE SHEATH WITHIN THE ACCORDION FOLDS. THE DEVICE WAS EXCHANGED FOR ANOTHER INTRODUCER; HOWEVER, THE FILTER WAS UNABLE TO BE RETRIEVED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10975159 ↗
• MalfunctionMar 24, 2020Difficult to Remove; Difficult to Remove

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9873729 ↗
• MalfunctionJul 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8803954 ↗
• MalfunctionAug 8, 2017Bent; Material Rupture; Stretched

  IT WAS REPORTED THE PROXIMAL TIP OF THE INTRODUCER (AFTER THE CHECK-FLO VALVE) IS RUPTURED. THE SHEATH WAS PLACED IN THE LEG, HOWEVER, THE DELIVERY OF THE STENT WAS NOT POSSIBLE. IT WAS NOTED THAT THE LOCK IMMEDIATELY AFTER THE VALVE HAD A CRACK. DEVICE IMAGING IDENTIFIED THE INTRODUCER WAS NOT CRACKED BUT BENT. HOWEVER, STRETCHING/ELONGATION IN THE MATERIAL IS PRESENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6773744 ↗