Gunther Tulip G13287 (REF GTRS-200-RB)Recalls & reported problems
Cook Incorporated · Gunther Tulip Vena Cava Filter Retrieval Set · Class 2
All models of Gunther Tulip (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Cook Gunther Tulip retrieval set is used to remove vena cava filters. Its 98 adverse event reports include 1 death, 12 injuries and 85 malfunctions. The reports mostly describe the set's parts separating, splitting or tearing during retrieval, such as sheaths ripping and hubs detaching. No recalls name this device.
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
- 98
- Deaths reported
- 1
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 00827002132870), received between Apr 7, 2016 and Feb 26, 2025 — classified as 1 death, 12 injuries, 85 malfunctions.
The most frequently reported specific device problem is “Material Separation” (42 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 Separation42
- Detachment of Device or Device Component25
- Break8
- Detachment Of Device Component6
- Material Split, Cut or Torn4
- Split3
- Difficult to Advance2
- Improper or Incorrect Procedure or Method2
Patient problems
- No Known Impact Or Consequence To Patient52
- No Consequences Or Impact To Patient34
- No Code Available8
- Blood Loss2
- Bradycardia1
- Cardiac Arrest1
- Death1
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 25 most recent of 98 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2025Mechanical Problem; Material Split, Cut or Torn; Mechanical Problem; Material Split, Cut or Torn
INFORMATION WAS AVAILABLE BUT INADVERTENTLY OMITTED FROM THE PREVIOUS REPORT. THE DEVICE WAS USED TO RETRIEVE ANOTHER MANUFACTURER¿S INFERIOR VENA CAVA FILTER THAT WAS PLACED (B)(6) 2024. THE DEVICE APPEARED NORMAL DURING PREPARATION. THERE WAS NO DIFFICULTY ADVANCING, REACHING, OR CAPTURING THE FILTER. BOTH THE BLACK AND BLUE SHEATHS REPORTEDLY RIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21471685 ↗MalfunctionApr 15, 2020Material Split, Cut or Torn; Material Split, Cut or Torn
AS INITIALLY REPORTED, DURING RETRIEVAL OF AN UNKNOWN FILTER USING A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET, THE FILTER COLLAPSED BUT WAS DIFFICULT TO DISENGAGE FROM THE CAVAL WALL. THE FILTER WAS ULTIMATELY REMOVED SUCCESSFULLY WITH THE COMPLAINT DEVICE. UPON EVALUATION OF THE RETURNED DEVICE ON 18SEP2019, A SPLIT WAS FOUND ON THE DISTAL END OF THE BLUE RETRIEVAL SHEATH. 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 9962119 ↗MalfunctionFeb 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING RETRIEVAL OF ANOTHER MANUFACTURER'S INFERIOR VENA CAVA FILTER, THE PIN VISE OF A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET BROKE OFF THE DEVICE. ACCORDING TO THE INITIAL REPORTER, THE FILTER WAS ORIGINALLY PLACED AT THE SAME FACILITY, AND THE REMOVAL WAS PART OF A SCHEDULED RETRIEVAL REQUEST FROM THE PATIENT. THE OTHER MANUFACTURER'S FILTER WAS REPORTEDLY DIFFICULT TO RELEASE FROM THE CAVAL WALL, AND AS THE USER PULLED BACK, PRESSURE WAS REPORTED. AS THE USER WAS "BRINGING DOWN" THE SYSTEM TO COLLAPSE THE FILTER, THE PIN VISE BROKE OFF. THE RETRIEVAL SET WAS REMOVED AND AN UNKNOWN 16 FRENCH SHEATH AND UNKNOWN SNARE WERE USED TO REMOVE THE FILTER. THE PHYSICIAN CONFIRMED THAT NOTHING SEPARATED IN THE PATIENT. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9745912 ↗MalfunctionJan 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING RETRIEVAL OF AN UNKNOWN INFERIOR VENA CAVA FILTER INVOLVING A PATIENT WITH A HISTORY OF ATRIAL FIBRILLATION AND HYPERTENSION, THE HUB SEPARATED FROM THE SHEATH INCLUDED IN A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET. THE FILTER, WHICH WAS ORIGINALLY PLACED (B)(6) 2019, WAS REPORTEDLY REMOVED DUE TO INFECTION RISK. ACCESS WAS OBTAINED IN THE RIGHT INTERNAL JUGULAR IN ORDER TO RETRIEVE THE 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 Consequences Or Impact To Patient
MAUDE report 9539376 ↗MalfunctionDec 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9495581 ↗MalfunctionNov 12, 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 Consequences Or Impact To Patient
MAUDE report 9311423 ↗MalfunctionNov 4, 2019Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Improper or Incorrect Procedure or Method; 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 Consequences Or Impact To Patient
MAUDE report 9272486 ↗MalfunctionOct 17, 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 Consequences Or Impact To Patient
MAUDE report 9202452 ↗MalfunctionOct 9, 2019Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Improper or Incorrect Procedure or Method; 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 Consequences Or Impact To Patient
MAUDE report 9172686 ↗MalfunctionSep 6, 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 Consequences Or Impact To Patient
MAUDE report 8969369 ↗MalfunctionSep 6, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ADDITIONAL INFORMATION WAS RECEIVED ON OCTOBER 14 NOTING THAT THE FILTER IN PLACE WAS A COOK MEDICAL GUNTHER TULIP, BUT THE DATE OF IMPLANTATION WAS NOT PROVIDED. THE PHYSICIAN ALSO NOTED THAT THE HUB SEPARATED FROM THE SHEATH WITH MINIMAL FORCE APPLIED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8969249 ↗MalfunctionAug 2, 2019Material 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 8855050 ↗MalfunctionJul 31, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE REGARDING A PATIENT OF UNKNOWN GENDER AND AGE, A SHEATH SEPARATION OCCURRED ON A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET. THE BLUE OUTER SHEATH SEPARATED FROM THE HUB OF THE DEVICE. ACCORDING TO THE INITIAL REPORTER, THE DEVICE WAS REMOVED ALL AT ONCE. 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 8846148 ↗MalfunctionJun 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING ATTEMPTED RETRIEVAL OF A COOK CELECT PLATINUM INFERIOR VENA CAVA (IVC) FILTER INVOLVING A (B)(6) YEAR-OLD MALE PATIENT WITH A HISTORY OF OBESITY, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET SHEATH SEPARATED AT THE HUB. REPORTEDLY, THE USER WAS "STRUGGLING" TO REMOVE THE FILTER. ANOTHER MANUFACTURER'S 6 FRENCH SNARE WAS USED THROUGH THE DEVICE. APPROXIMATELY ONE HOUR INTO THE PROCEDURE, THE HUB OF THE OUTER 11 FRENCH SHEATH BECAME DISCONNECTED FROM THE SHEATH WHEN THE USER WAS INSERTING THE INNER 9 FRENCH SHEATH. THE DEVICE HAD PREVIOUSLY BEEN IN THE PATIENT, HOWEVER, THE SEPARATION OCCURRED ON THE PREPARATION TABLE. OTHER UNKNOWN DEVICES AND MULTIPLE TECHNIQUES WERE USED TO ATTEMPT TO REMOVE THE FILTER, INCLUDING AN ADVANCED RETRIEVAL ("HANG MAN") TECHNIQUE. THE CELECT FILTER WAS ULTIMATELY UNABLE TO BE RETRIEVED DUE TO THE HOOK OF THE FILTER BEING EMBEDDED IN THE CAVAL WALL. THIS EVENT HAS BEEN REPORTED UNDER PATIENT IDENTIFIER (B)(6). THE FILTER WAS ORIGINALLY PLACED IN (B)(6) OF 2018. A SECTION OF THE COMPLAINT DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INI
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8727290 ↗MalfunctionJun 12, 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 Consequences Or Impact To Patient
MAUDE report 8692734 ↗MalfunctionMay 28, 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 Consequences Or Impact To Patient
MAUDE report 8647490 ↗InjuryMay 23, 2019Material Separation; Material Separation
CORRECTION: THE DEVICE ASSOCIATED WITH THIS REPORT WAS MANUFACTURED BY WILLIAM COOK EUROPE, NOT COOK INCORPORATED. THE COMPLAINT FILE WILL BE TRANSFERRED TO WILLIAM COOK EUROPE AND COOK, INC. WILL NOT SEND ANY ADDITIONAL FOLLOW-UP REPORTS REGARDING THIS EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 8636696 ↗MalfunctionMay 8, 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 Consequences Or Impact To Patient
MAUDE report 8591833 ↗MalfunctionMay 6, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
AS REPORTED, DURING RETRIEVAL OF AN UNKNOWN INFERIOR VENA CAVA (IVC) FILTER, A SHEATH INCLUDED IN THE GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET SPLIT. AS THE SNARE WAS ADVANCED UNDER IMAGING, THE USER SAW THAT THE SNARE AND SHEATH WERE ADVANCING IN OPPOSITE DIRECTIONS, ONE TO THE LEFT AND ONE TO THE RIGHT. THE DEVICE WAS THEN REMOVED SAFELY. UPON EXAMINATION OF THE PRODUCT, THE SHEATH WAS OBSERVED TO BE SPLIT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET. 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 8583962 ↗MalfunctionMay 6, 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 Consequences Or Impact To Patient
MAUDE report 8582966 ↗InjuryApr 2, 2019Entrapment of Device; Device Damaged by Another Device; Entrapment of Device; Device Damaged by Another Device
IT WAS REPORTED, A (B)(6) FEMALE WAS UNDERGOING A CELECT FILTER PLACEMENT PROCEDURE. THE FILTER ONLY PARTIALLY RELEASED FROM THE DELIVERY SYSTEM WITH DIFFICULTY. A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET WAS USED TO ATTEMPT TO RETRIEVE THE CELECT FILTER THROUGH THE CELECT PLATINUM DELIVERY SHEATH BUT FAILED BECAUSE THE GOOSENECK SNARE WAS ATTACHED TO ONE OF THE SECONDARY LEGS OF THE FILTER AND BENT BACK ON A LOOP. IT WAS NOT ABLE TO RELEASE FROM THE FILTER LEG AND, SINCE IT WAS INTRODUCED THROUGH THE CELECT PLATINUM SHEATH DELIVERY SET, THE PHYSICIAN WAS NOT ABLE TO ADVANCE THE SHEATH OVER THE GOOSE NECK SNARE AND CELECT PLATINUM FILTER. THE PATIENT REQUIRED TRANSFER TO THE MAIN HOSPITAL FACILITY, WITH THE DELIVERY SHEATH AND THE GOOSENECK SNARE EXITING THE PATIENT'S INTERNAL JUGULAR VEIN. THE RETRIEVAL DEVICE AND THE FILTER WERE SUCCESSFULLY REMOVED. ACCORDING TO THE COMPLAINANT, THERE ARE NO PLANS TO ATTEMPT ANOTHER FILTER PLACEMENT. THE COMPLAINT DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER TO AID IN THE INVESTIGATION.
Patient problems: No Code Available
MAUDE report 8473938 ↗MalfunctionMar 27, 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 Consequences Or Impact To Patient
MAUDE report 8458723 ↗MalfunctionMar 27, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
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 8457236 ↗MalfunctionMar 15, 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 Consequences Or Impact To Patient
MAUDE report 8426138 ↗MalfunctionFeb 14, 2019Material 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 8340839 ↗
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- EN Snare® 00884450452462Merit Medical Systems, Inc. · Device, percutaneous retrieval7 reports
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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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