CloverSnare G53008Recalls & reported problems
Cook Incorporated · CloverSnare 4-Loop Vascular Retriever · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Cook Medical CloverSnare 4-Loop Vascular Retriever is a wire loop snare used to grab and remove implanted devices, such as vena cava filters, from inside blood vessels. The 32 reports mostly describe the snare coming apart during procedures, with the loop or its handle detaching and sometimes being lost in the patient, along with fraying, breaking, and difficulty reaching or grabbing the filter. Five reports describe injuries and no deaths. No recalls name this device, and no reports were filed in the past 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10827002530086), received between Oct 11, 2016 and Jul 8, 2024 — classified as 5 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Material Separation” (9 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Separation9
- Detachment of Device or Device Component7
- Difficult to Remove6
- Fracture4
- Break3
- Material Frayed2
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- No Consequences Or Impact To Patient7
- No Known Impact Or Consequence To Patient6
- Insufficient Information2
- No Code Available2
- Foreign Body In Patient1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2024Break; Material Separation; Break; Material Separation
INFORMATION WAS AVAILABLE BUT INADVERTENTLY OMITTED FROM THE PREVIOUS REPORT. THE INTENDED PROCEDURE WAS A VENOGRAM WITH FILTER RETRIEVAL. IT IS UNKNOWN HOW LONG THE FILTER HAD BEEN IN PLACE. THE FILTER WAS NOT INSIDE OF THE COMPLAINT DEVICE WHEN THE SNARE DISCONNECTED. THE FILTER'S LEGS/FEET WERE EMBEDDED IN THE CAVAL WALL, AND THE FILTER WAS UNABLE TO BE RETRIEVED. THE PHYSICIAN ELECTED TO LEAVE THE FILTER IN PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19691287 ↗MalfunctionMar 13, 2024Detachment 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 Clinical Signs, Symptoms or Conditions
MAUDE report 18895913 ↗MalfunctionNov 21, 2023Break; Break
ADDITIONAL INFORMATION WAS RECEIVED 12DEC2023. THE TYPE OF FILTER BEING RETRIEVED AT THE TIME OF THE EVENT IS UNKNOWN, AND IT IS UNKNOWN HOW LONG THE FILTER HAD BEEN IN PLACE. THE FILTER FEET WERE NOT EMBEDDED IN THE CAVAL WALL AND THE FILTER WAS NOT DIFFICULT TO RETRIEVE. THE COAXIAL SHEATH SYSTEM WAS ADVANCED COMPLETELY OVER THE FILTER, WITH THE OUTER SHEATH ADVANCED PAST THE TIP OF THE INNER SHEATH, AND THE FILTER WAS FULLY COLLAPSED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18182291 ↗MalfunctionOct 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING RETRIEVAL OF AN UNKNOWN FILTER, THE PIN VISE SEPARATED FROM A CLOVERSNARE 4-LOOP VASCULAR RETRIEVER'S SNARE. THE FEET/LEGS OF THE FILTER, WHICH HAD BEEN IN PLACE FOR FIVE MONTHS, WERE NOT EMBEDDED IN THE CAVAL WALL. THE HOOK OF THE FILTER WAS CAPTURED WITH THE SNARE AND THE USER BEGAN TO "SHEATH" THE FILTER, WHILE APPLYING BACK TENSION ON THE SNARE. THE PIN VISE THEN SEPARATED AND THE ENTIRE SNARE CAME OUT OF THE CATHETER. THE SNARE WAS UNABLE TO BE RE-THREADED INTO THE TUOHY-BORST ADAPTER AND THEREFORE THE USER PLACED THE SNARE THROUGH THE SIDE-ARM. THE FILTER HOOK WAS SNARED AND THE FILTER WAS REMOVED FROM THE PATIENT. 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 Clinical Signs, Symptoms or Conditions
MAUDE report 17965733 ↗MalfunctionSep 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING RETRIEVAL OF ANOTHER MANUFACTURER'S INFERIOR VENA CAVA FILTER, A CLOVERSNARE 4-LOOP VASCULAR RETRIEVER SET'S "TORQUE DEVICE" CAME OFF/DETACHED AND WAS LOST DURING REMOVAL OF THE DEVICE. ACCESS WAS OBTAINED IN THE JUGULAR VEIN. ONLY THE DEVICES THAT CAME WITH THE CLOVERSNARE SET WERE USED TO RETRIEVE THE FILTER. THE FILTER WAS DIFFICULT TO REMOVE, AS IT WAS EMBEDDED IN THE CAVAL WALL, AND RESISTANCE WAS ENCOUNTERED UPON REMOVAL. REPORTEDLY, AFTER THE "TORQUE DEVICE" DETACHED, THE SNARE WENT INTO THE CATHETER AND THE FILTER WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT, COMPLETING THE PROCEDURE. 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 Clinical Signs, Symptoms or Conditions
MAUDE report 17740917 ↗MalfunctionAug 11, 2023Break; Break
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information
MAUDE report 17513330 ↗MalfunctionApr 26, 2023Difficult to Remove; Deformation Due to Compressive Stress; Material Twisted/Bent; Difficult to Remove; Deformation Due to Compressive Stress; Material Twisted/Bent
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16817765 ↗InjuryApr 26, 2023Difficult to Remove; Difficult to Remove
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16817761 ↗MalfunctionApr 11, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
AS REPORTED, DURING RETRIEVAL OF AN UNKNOWN INFERIOR VENA CAVA (IVC) FILTER, THE PIN VISE CAME OFF OF A CLOVERSNARE 4-LOOP VASCULAR RETRIEVER'S SNARE WIRE. THE PHYSICIAN CAPTURED THE HOOK OF THE NON-COOK FILTER WITH THE SNARE AND PULLED THE SNARE BACK TO LOCK IT IN THE CATHETER. THE TUOHY-BORST WAS TIGHTENED AND THE USER TRIED TO ADVANCE THE CATHETER TO RETRIEVE THE FILTER; HOWEVER, THE PIN VISE POPPED OFF THE BACK OF THE SNARE WIRE. THE SNARE WIRE WAS INSIDE THE TUOHY-BORST ADAPTER, AND BECAUSE THERE WAS NO WIRE OUTSIDE OF THE TUOHY, THE USER HAD TO REMOVE THE SNARE CATHETER TO ACCESS THE SNARE WIRE. THE SAME SYSTEM WAS THEN ADVANCED OVER THE FILTER TO COLLAPSE IT. THE USER REMOVED THE INNER SHEATH, SNARE, AND FILTER TOGETHER, LEAVING THE OUTER 10-FRENCH SHEATH IN PLACE TO PERFORM A POST-PROCEDURE VENOGRAM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE COMPLAINT DEVICE. 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 Clinical Signs, Symptoms or Conditions
MAUDE report 16714803 ↗MalfunctionApr 3, 2023Difficult to Remove; Stretched; Difficult to Remove; Stretched
AS REPORTED, DURING AN INFERIOR VENA CAVA (IVC) FILTER RETRIEVAL, A CLOVERSNARE 4-LOOP VASCULAR RETRIEVER'S INNER SHEATH "FRACTURED". AFTER SNARING THE UNSPECIFIED FILTER, THE INNER SHEATH WAS ADVANCED OVER THE FILTER AND "FRACTURED" NEAR THE HANDLE OUTSIDE THE PATIENT'S BODY. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THE OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. UPON PRELIMINARY DEVICE EVALUATION OF THE RETURNED DEVICE, THE INNER SHEATH WAS ELONGATED AND DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16665499 ↗MalfunctionOct 11, 2022Material Frayed; Difficult to Remove; Material Frayed; Difficult to Remove
ADDITIONAL INFORMATION WAS RECEIVED 21OCT2022. THE FILTER BEING RETRIEVED AT THE TIME OF THE EVENT WAS A COOK GUNTHER TULIP, WHICH HAD BEEN IN PLACE FOR THREE MONTHS. THE FILTER WAS NOT EMBEDDED WITHIN THE CAVAL WALL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15581890 ↗MalfunctionSep 15, 2022Peeled/Delaminated; Peeled/Delaminated
AS REPORTED, DURING A PROCEDURE INVOLVING REMOVAL OF A COOK CELECT INFERIOR VENA CAVA FILTER, AN UNKNOWN LONG STRING WAS NOTED TO BE HANGING FROM A CLOVERSNARE 4-LOOP VASCULAR RETRIEVER'S SHEATH, AFTER THE SNARE AND FILTER WERE PULLED FROM THE SHEATH. THE PROCEDURE HAD BEEN SUCCESSFULLY COMPLETED WHEN THE EVENT OCCURRED. FLUOROSCOPY WAS USED TO LOOK FOR ADDITIONAL PIECES WITHIN THE PATIENT; HOWEVER, NOTHING WAS FOUND. 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 Clinical Signs, Symptoms or Conditions
MAUDE report 15427780 ↗InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED, DURING A FILTER RETRIEVAL PROCEDURE IN WHICH A CLOVERSNARE 4-LOOP VASCULAR RETRIEVER WAS USED, ANOTHER MANUFACTURER'S WIRE GUIDE SEPARATED AND REMAINS IN THE PATIENT. THE OTHER MANUFACTURER'S FILTER WAS PLACED IN (B)(6) 2021. DURING THE RETRIEVAL PROCEDURE, THE PHYSICIAN WAS ATTEMPTING A WIRE LOOP-SNARE TECHNIQUE THROUGH AN UNSPECIFIED COOK 16 FRENCH, 45-CENTIMETER SHEATH. THE OTHER MANUFACTURER'S 0.035-INCH, 260-CENTIMETER WIRE WAS SNARED, AND WHILE PULLING THE DEVICE THROUGH THE SHEATH, THE WIRE SEPARATED. THE SEPARATED SEGMENT OF THE WIRE WAS NOTED ON IMAGING. THE PROCEDURE WAS STOPPED DUE TO THE LENGTH OF THE PROCEDURE, AS THE PATIENT HAD RECEIVED 6 MGY OF RADIATION. THE FILTER WAS NOT RETRIEVED. REPORTEDLY, THE PHYSICIAN FELT THAT THE WIRE FRAGMENT WOULD NOT MOBILIZE; THEREFORE, IT WAS LEFT IN THE PATIENT. THE PHYSICIAN PERFORMING THE PROCEDURE WILL CONSULT WITH THE REFERRING PHYSICIAN. THERE HAS BEEN NO ALLEGED MALFUNCTION OF ANY COOK DEVICE. 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: Foreign Body In Patient
MAUDE report 15074103 ↗InjuryJun 14, 2022Difficult to Remove; Difficult to Remove
AS REPORTED, DURING RETRIEVAL OF AN UNKNOWN INFERIOR VENA CAVA (IVC) FILTER, A CLOVERSNARE 4-LOOP VASCULAR RETRIEVER'S SNARE BECAME "JAILED" ON A LEG OF THE FILTER. A PHOTO PROVIDED BY THE CUSTOMER SHOWS WHAT APPEARS TO BE THE SNARE LOOP ENTANGLED WITH ONE OR MORE FILTER LEGS/TINES. THE IVC WAS OPENED BY A VASCULAR SURGEON, AND THE FILTER WAS REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14687319 ↗MalfunctionNov 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12843532 ↗MalfunctionSep 9, 2021Material Separation; Material Separation
AS REPORTED, DURING RETRIEVAL OF A CELECT IVC FILTER, A WIRE OF A CLOVERSNARE¿ 4-LOOP VASCULAR RETRIEVER BROKE. THE FILTER WAS IMPLANTED APPROXIMATELY 2 YEARS PREVIOUSLY. ACCESS WAS GAINED THROUGH THE RIGHT JUGULAR VEIN. THE USER WAS ABLE TO HOOK THE FILTER WITH THE CLOVER SNARE. THE USER THEN ADVANCED THE RETRIEVAL SHEATH OVER THE SNARE, BUT AS THEY WERE HOLDING TENSION ON THE SNARE WIRE, THE SNARE WIRE BROKE. THE BROKEN WIRE WAS OUTSIDE THE PATIENT, BUT THE BROKEN WIRE RETRACTED BACK WITHIN THE SNARE CATHETER AND RETRIEVAL SHEATH. THE USER CUT A PORTION OF THE SNARE CATHETER OFF TO RETRIEVE THE BROKEN END OF THE SNARE WIRE. THE USER THEN USED HEMOSTATS TO HOLD THE END OF THE WIRE AND SUCCESSFULLY RETRIEVE THE FILTER AND RETRIEVAL SET FROM THE PATIENT. NO PORTION OF THE DEVICE WAS LEFT WITHIN THE PATIENT. THERE WAS NO NEED WITH ADDITIONAL PROCEDURES OR PROLONGED HOSPITALIZATION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12446551 ↗MalfunctionSep 7, 2021Material Separation; Material Separation
ADDITIONAL INFORMATION WAS RECEIVED 04MAY2022, CLARIFYING THAT THE DEVICE DID NOT MAKE PATIENT CONTACT. THE DEVICE WAS ONLY HANDLED ON THE BACK TABLE PRIOR TO USE. AFTER THE SIDE-ARM SEPARATED, THE DEVICE WAS FURTHER MANIPULATED, RESULTING IN THE STATE IN WHICH IT WAS RETURNED TO COOK (SEPARATED).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12434011 ↗MalfunctionDec 17, 2020Fracture; Fracture
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11026800 ↗MalfunctionJun 4, 2020Fracture; Fracture
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10120518 ↗MalfunctionMar 21, 2020Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9863467 ↗MalfunctionMar 21, 2020Fracture; Fracture
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9863460 ↗MalfunctionAug 12, 2019Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS REPORT WAS SUBMITTED ON (B)(6) 2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8883106 ↗InjuryJul 16, 2019Material Separation; Material Separation
NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 16JUL2019.
Patient problems: No Code Available
MAUDE report 8796738 ↗MalfunctionMay 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ADDITIONAL INFORMATION WAS RECEIVED 16MAY2019 WHICH PROVIDED THE IVC FILTER WAS NOT A COOK DEVICE. IT WAS ANOTHER MANUFACTURER'S RETRIEVABLE FILTER WHICH HAD BEEN IN PLACE APPROXIMATELY ONE YEAR AND WAS REMOVED VIA THE INTERNAL JUGULAR ROUTE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8617224 ↗MalfunctionJul 16, 2018Material Frayed; Material Frayed
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 7690967 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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