Gunther Tulip G13287 (REF GTRS-200-RB)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20827002132874), received between Mar 14, 2025 and Apr 11, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2026Difficult to Fold, Unfold or Collapse; Detachment of Device or Device Component

  AS REPORTED, DURING ATTEMPTED RETRIEVAL OF AN UNSPECIFIED COOK CELECT FILTER, THE ¿Y-CONNECTOR¿ SEPARATED FROM A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET¿S SNARE. THE FILTER HAD BEEN IN PLACE FOR TWELVE YEARS. PER THE REPORTER, THE HOOK OF THE FILTER WAS EASILY CAPTURED WITH THE SNARE. A MODERATE AMOUNT OF FORCE WAS NEEDED TO ADVANCE THE SHEATHS OVER THE FILTER IN ORDER TO COLLAPSE IT, AND THE ¿CONNECTION BETWEEN THE INNER AND OUTER SHEATH BROKE.¿ THE OUTER SHEATH ACCORDIONED OUTSIDE OF THE ACCESS SITE/BODY, AND THE ¿Y-CONNECTOR¿ BROKE FROM THE SNARE. THE COMPLAINT DEVICE WAS REMOVED WITHOUT DIFFICULTY. THE RETRIEVAL PROCEDURE WAS ABORTED AND RESCHEDULED TO BE COMPLETED ANOTHER DAY. A SECTION OF THE COMPLAINT DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24847538 ↗
• MalfunctionMar 12, 2026Difficult to Fold, Unfold or Collapse; Material Split, Cut or Torn

  AS REPORTED, DURING RETRIEVAL OF AN UNKNOWN INFERIOR VENA CAVA FILTER, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET'S SHEATH CRACKED. PER THE REPORTER, THE PROCEDURE WENT WELL AND WAS SUCCESSFUL. UPON REMOVAL OF THE DEVICE FROM THE PATIENT, THE USER NOTED THAT THE SHEATH WAS RIPPED/CRACKED. REPORTEDLY, MEDICAL STAFF SPECULATED THAT ONE OF THE FILTER LEGS RIPPED THE SHEATH. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582121 ↗
• MalfunctionJan 7, 2026Component Incompatible; 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 23995762 ↗
• MalfunctionAug 18, 2025Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  AS REPORTED, DURING RETRIEVAL OF AN UNKNOWN INFERIOR VENA CAVA FILTER, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET'S SNARE LOOP SEPARATED FROM THE SHAFT AS THE USER ATTEMPTED TO PULL THE FILTER BACK INTO THE GUIDE. PER THE REPORTER, THE RETRIEVAL CASE WAS DIFFICULT, AS THE FILTER WAS SLIGHTLY ANGLED AND ONE LEG WAS POSSIBLY EMBEDDED DEEP INTO THE CAVAL WALL. THE PATIENT IS REPORTEDLY "FINE". A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22829946 ↗
• InjuryAug 12, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  AS REPORTED, DURING A PROCEDURE INVOLVING RETRIEVAL OF AN UNKNOWN FILTER, THE SNARES OF TWO GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SETS BROKE OFF INSIDE THE PATIENT (REPORTED UNDER PATIENT IDENTIFIERS (B)(6)). PER THE REPORTER, THE PHYSICIAN WAS BEING TOO AGGRESSIVE DURING RETRIEVAL ATTEMPTS, WHICH IS BELIEVED TO HAVE CONTRIBUTED TO THE DEVICES BREAKING. ONE SNARE WAS SUCCESSFULLY RETRIEVED, AND THE OTHER SNARE FRAGMENT REMAINED IN THE PATIENT, LIKELY HOOKED WITHIN THE FILTER. IT IS UNKNOWN HOW THE RETRIEVED SNARE WAS RECOVERED. ONE OF THE RETRIEVAL SETS¿ BLUE OUTER SHEATHS ALSO SEPARATED FROM THE WHITE HUB; HOWEVER, IT IS UNKNOWN IF THE HUB SEPARATED BEFORE OR AFTER THE SNARE BROKE, AND IT IS UNKNOWN WHICH SET WAS INVOLVED. THE PROCEDURE WAS ABORTED. ALTHOUGH IT IS UNKNOWN WHICH SNARE FRAGMENT REMAINS IN THE PATIENT, THE SERIOUS INJURY WILL BE REPORTED UNDER PATIENT IDENTIFIER (B)(6) (SUBJECT OF THIS REPORT).

  Patient problems: Foreign Body In Patient

  MAUDE report 22786169 ↗
• MalfunctionMar 14, 2025Unraveled Material; Unraveled Material

  AS REPORTED, DURING A FILTER RETRIEVAL PROCEDURE, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET¿S WIRE UNRAVELED WHILE OBTAINING ACCESS IN THE INTERNAL JUGULAR VEIN. ACCESS WAS REPORTEDLY DIFFICULT, AS THE VEIN/ACCESS SITE HAD BEEN USED FOR PREVIOUS INTERVENTIONS. THE USER CONTINUED TO USE THE WIRE, DESPITE IT UNRAVELING. THE UNKNOWN FILTER WAS SUCCESSFULLY RETRIEVED AS INTENDED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21606878 ↗