Greenfield™ M001505010Recalls & reported problems

Summary

The FDA's MAUDE database contains 113 adverse event reports that list this exact device (DI 08714729124993), received between Jun 4, 2018 and Nov 2, 2022 — classified as 97 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (71 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 25 most recent of 113 reports, in the reporter's own words as published by the FDA.

• InjuryNov 2, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE FILTER WAS TILTED AND HAD PERFORATED THE CONFINES OF THE INFERIOR VENA CAVA (IVC) AND INTO SURROUNDING STRUCTURES. ON (B)(6) 2009, THE PATIENT WAS IMPLANTED WITH THE GREENFIELD FILTER. ON (B)(6) 2020, THE PATIENT UNDERWENT AN ABDOMINAL AND PELVIC CT SCAN. THE FILTER WAS OBSERVED TO BE TILTED, WITH THE APEX ABUTTING THE IVC WALL. MULTIPLE STRUTS HAD PERFORATED THE IVC WALL, WITH ONE STRUT PERFORATING THE SMALL INTESTINE. THERE WERE NO FURTHER REPORTED PATIENT COMPLICATIONS.

  Patient problems: Perforation

  MAUDE report 15718733 ↗
• InjuryOct 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FILTER HAD PERFORATED THE SURROUNDING STRUCTURES. ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH GREENFIELD FILTER FOR CONTROL OF PULMONARY EMBOLISM (PE). ON (B)(6) 2020, THE PATIENT RECEIVED AN ABDOMINAL CT SCAN. THE INFERIOR VENA CAVA (IVC) FILTER WAS NOTED TO HAVE PERFORATED THE CONFINES OF THE IVC. THERE WAS A 3 MM AORTIC PERFORATION, A 4 MM RENAL PERFORATION, AND 3 MM MESENTERIC PERFORATION. THERE WAS NO EVIDENCE OF TILTING, FRACTURE, STENOSIS OR MIGRATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 15572473 ↗
• InjurySep 8, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE FILTER WAS TILTED AND HAD PERFORATED THE INFERIOR VENA CAVA (IVC). ON (B)(6) 2007, THE PATIENT WAS IMPLANTED WITH A GREENFIELD FILTER. ON (B)(6) 2020, THE PATIENT RECEIVED AN ABDOMINAL CT SCAN. THE SUPERIOR TIP OF THE FILTER WAS TILTED LATERALLY TOWARD THE RIGHT. ADDITIONALLY, THE FILTER STRUTS EXTENDED BEYOND THE IVC LUMEN ANTERIORLY AND LATERALLY TOWARD THE RIGHT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 15381268 ↗
• InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2002, THE PATIENT WAS IMPLANTED WITH A GREENFIELD FILTER AFTER DIAGNOSIS AND TREATMENT OF A DEEP VEIN THROMBOSIS. ON OR ABOUT (B)(6) 2019, THE PATIENT UNDERWENT A COMPUTERIZED TOMOGRAPHY SCAN (CT SCAN) OF THEIR ABDOMEN AND PELVIS. THE PATIENT WAS INFORMED THAT THE FILTER'S STRUTS PERFORATED BEYOND THE INFERIOR VENA CAVA (IVC) WALL.

  Patient problems: Perforation

  MAUDE report 15129299 ↗
• InjuryJul 14, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE FILTER HAD TITLED AND PERFORATED THE IVC. A GREENFIELD IVC FILTER WAS IMPLANTED INTO THE INFERIOR VENA CAVA (IVC) ON (B)(6) 2008 AFTER TREATMENT OF DEEP VEIN THROMBOSIS (DVT). ON (B)(6) 2020, A COMPUTATED TOMOGRAPHY (CT) SCAN WAS PERFORMED OF THE ABDOMEN AND PELVIS. THE SCAN REVEALED THAT THE FILTER HAD TITLED AND CONTACTS THE ANTERIOR WALL OF THE IVC. THE LEFT LATERAL STRUTS PERFORATED THE IVC WALL AND THERE IS A 3MM VERTEBRAL PERFORATION.

  Patient problems: Perforation

  MAUDE report 15021554 ↗
• InjuryJul 14, 2022Break; Break

  ON OR ABOUT (B)(6) 2005, THE PATIENT WAS SURGICALLY IMPLANTED WITH A GREENFIELD STAINLESS STEEL VENA CAVA FILTER AFTER DIAGNOSIS AND TREATMENT OF A DEEP VEIN THROMBOSIS. ON OR ABOUT (B)(6) 2020, THE PATIENT UNDERWENT A COMPUTERIZED TOMOGRAPHY SCAN (CT SCAN) OF THEIR ABDOMEN AND PELVIS. THE CT SCAN REVEALED THEIR INFERIOR VENA CAVA (IVC) WAS SMALL AT THE LEVEL OF THEIR IVC FILTER WHICH MAY BE SECONDARY TO IVC THROMBOSIS. ADDITIONALLY, A POSTERIOR STRUT PERFORATED THE IVC WALL BY 3.5MM, AND A STRUT FRACTURE WAS SEEN.

  Patient problems: Perforation; Thrombosis/Thrombus

  MAUDE report 15021146 ↗
• InjuryMar 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A PULMONARY EMBOLISM. A GREENFIELD FILTER WAS IMPLANTED ON (B)(6) 2007. ON (B)(6) 2008 THE PATIENT WAS DIAGNOSED WITH HAVING A PULMONARY EMBOLISM. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pulmonary Embolism

  MAUDE report 11581831 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PULMONARY EMBOLISM. A GREENFIELD FILTER WAS IMPLANTED ON (B)(6) 2010. ON (B)(6) 2014 A PULMONARY EMBOLISM WAS OBSERVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Embolism/Embolus

  MAUDE report 11453696 ↗
• InjuryApr 13, 2020Positioning Problem; Positioning Problem

  ON (B)(6)2007 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2018 A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THE APEX OF THE FILTER WAS 16-17 DEGREES TO THE LEFT AND WAS TOUCHING THE LEFT SIDE OF THE INFERIOR VENA CAVA (IVC) WALL. ALL 6 STRUTS PERFORATE THE IVC WALL AND EXTEND 1-3 MM INTO SURROUNDING FAT. A MESENTERIC PERFORATION WAS NOTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Perforation

  MAUDE report 9955868 ↗
• InjuryApr 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERFORATION OCCURRED. ON (B)(6) 2007, THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019, A COMPUTED TOMOGRAPHY (CT) SCAN CONFIRMED NO SIGNIFICANT TILT. THE FILTER TINES EXTEND BEYOND THE WALL OF INFERIOR VENA CAVA (IVC). IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER ON (B)(6) 2007.

  Patient problems: Perforation

  MAUDE report 9949160 ↗
• InjuryApr 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2009 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED EXTRALUMINAL EXTENSION OF THE STRUT ALONG THE POSTERIOR ASPECT MEASURING 4MM. NO FRACTURE OF THE FILTER OR STRUT WAS NOTED.

  Patient problems: Perforation

  MAUDE report 9949028 ↗
• InjuryApr 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2001, THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019, A COMPUTED TOMOGRAPHY (CT) SCAN SHOWED POSITIVE MESENTERIC PERFORATION. PERIRENAL INFERIOR VENA CAVA FILTER WAS NOTED TO HAVE ONE OF THE PRONGS EXTENDING 1MM OUTSIDE THE INFERIOR VENA CAVA (IVC) WALL.

  Patient problems: Perforation

  MAUDE report 9949010 ↗
• MalfunctionApr 10, 2020Positioning Problem; Positioning Problem

  ON (B)(6) 2015 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2020, A COMPUTED TOMOGRAPHY (CT) SCAN OF THE ABDOMEN REVEALED THAT THE FILTER WAS SLIGHTLY TILED BACKWARDS WITH ITS SUPERIOR TIP APPEARING TO BE IMPLANTED WITHIN THE POSTERIOR INFERIOR VENA CAVA (IVC) WALL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9949009 ↗
• InjuryApr 10, 2020Positioning Problem; Positioning Problem

  ON (B)(6) 2000, THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER (IVC). ON (B)(6) 2019 A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THAT THE GREENFIELD VENA CAVA FILTER WAS IN PLACE WITH A MODERATE LEFTWARD TILT. A COUPLE OF STRUTS WERE ALSO NOTED TO BE PERFORATING THE INFERIOR VENA CAVA (IVC) UP TO 6MM WITHOUT ENCROACHMENT INTO BOWEL OR AORTA.

  Patient problems: Perforation

  MAUDE report 9948888 ↗
• InjuryApr 10, 2020Positioning Problem; Positioning Problem

  ON (B)(6) 2014 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019, A COMPUTATED TOMOGRAPHY (CT) SCAN REVEALED THE FILTER WAS POSITION BELOW THE LEVEL OF THE RENAL VEINS. THERE IS TILTING PROXIMALLY TO RIGHT BY 12 DEGREES. DISTAL ANCHORING STRUTS DO NOT EXTEND BEYOND VESSEL WALL. SECOND IVC FILTER LIES OUTSIDE VASCULAR SYSTEM IN RIGHT RETROPERITONEUM ALONG POSTERO-MEDIAL ASPECT OF ROOT PSOAS MUSCLE. ANCHORING STRUTS MAY BE WITHIN RIGHT COMMON ILIAC VEIN.

  Patient problems: Perforation

  MAUDE report 9948494 ↗
• InjuryApr 9, 2020Positioning Problem; Positioning Problem

  ON (B)(6) 2012, THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD INFERIOR VENA CAVA (IVC) FILTER. ON (B)(6) 2019, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED TILT AND PERFORATION. THE IVC FILTER WAS LOCATED BELOW THE LEVEL OF THE RENAL VEINS APPROXIMATELY ABOUT 1.8CM. THE APEX OF THE IVC FILTER WAS TOUCHING THE ANTERIOR WALL OF THE IVC. THERE APPEARED TO BE MILD ANTERIOR TILT AT THE APEX WHICH MEASURED UP TO 10 DEGREES. THE TIPS OF ALL LIMBS OF THE IVC FILTER PROTRUDED BEYOND THE WALL OF THE IVC UP TO 2-3MM.

  Patient problems: Perforation

  MAUDE report 9947462 ↗
• InjuryApr 9, 2020Positioning Problem; Positioning Problem

  ON (B)(6) 2005, THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD INFERIOR VENA CAVA (IVC) FILTER. ON (B)(6) 2019, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED POSITIVE TILT AND MESENTERIC PERFORATION. THE FILTER WAS TILTED TO THE LEFT WITH ITS PROXIMAL CONE LYING ON THE WALL OF THE IVC, POSSIBLY EMBEDDED IN IT. SOME OF THE FILTER STRUTS HAVE PENETRATED THROUGH THE WALL OF THE IVC INTO THE PRECAVAL/MESENTERIC FAT. THERE WAS NO SIGN OF MIGRATION, FRACTURE OR STENOSIS.

  Patient problems: Perforation

  MAUDE report 9946855 ↗
• InjuryApr 9, 2020Positioning Problem; Migration; Positioning Problem; Migration

  ON (B)(6) 2001, THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THAT THE IVC FILTER TIP WAS LOCATED ABNORMALLY LOW BELOW THE LOWEST RENAL VEIN, BEGINNING 3CM INFERIOR TO LEFT RENAL VEIN. IT WAS ABNORMALLY TILTED BY 32 DEGREES TO THE LEFT AND 10 DEGREES POSTERIORLY. THERE WAS A PERFORATION OF ALL STRUTS WITHOUT FRACTURE. NUMEROUS STRUTS PERFORATED UP TO 14MM BEYOND THE LUMEN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: Perforation

  MAUDE report 9946850 ↗
• InjuryApr 9, 2020Positioning Problem; Positioning Problem

  ON (B)(6) 2016, THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD INFERIOR VENA CAVA (IVC) FILTER. ON (B)(6) 2018, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED ABNORMAL TILTING OF THE FILTER OF OVER 20 DEGREES. IT WAS ALSO NOTED THAT MULTIPLE STRUTS WERE PERFORATING THE IVC WALL UP TO 4MM AND THE IVC STRUTS EXTENDED AND ABUTTED THE THIRD PORTION OF THE DUODENUM AND AORTIC WALL. THERE WAS NO EVIDENCE OF MIGRATION, FRACTURE OR STENOSIS.

  Patient problems: Perforation

  MAUDE report 9946792 ↗
• InjuryApr 9, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED A PERFORATION AND TILT OCCURRED. ON (B)(6) 2003, THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6)2018, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THE FILTER IS TILTED POSTERIORLY WITH THE TIP ABUTTING THE POSTERIOR WALL OF THE IVC. ALSO, FOUR OF THE SIX STRUTS PERFORATE THE IVC WALL.

  Patient problems: Perforation

  MAUDE report 9944333 ↗
• InjuryApr 9, 2020Positioning Problem; Positioning Problem

  ON (B)(6) 2008 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED TILT OF THE FILTER AND MESENTERIC PERFORATION. THERE WAS MINIMAL STRUT WALL PERFORATION ALONG THE TIP OF FIVE (5) AND SIX (6) OF THE CAVAL LEGS, WITH NO ORGAN PENETRATION. THERE WAS A 30 DEGREE TILT TO THE RIGHT. NO STENOSIS, FRACTURE, OR MIGRATION OF THE FILTER WAS NOTED.

  Patient problems: Perforation

  MAUDE report 9943899 ↗
• InjuryApr 9, 2020Positioning Problem; Positioning Problem

  ON (B)(6) 2007, THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2018, MSR2 COMPUTED TOMOGRAPHY (CT) SCAN REVEALED TWO OF THE FILTER PRONGS LAYING ANTERIOR AND APPEAR TO EXTEND BEYOND THE MARGIN OF THE WALL OF THE INFERIOR VENA CAVA (IVC) AND TWO OTHER PRONGS MAY ALSO EXTEND BEYOND THE LUMEN. THE FILTER IS SOMEWHAT TILTED POINTING POSTERIOR AND LATERALLY TO THE RIGHT SIDE.

  Patient problems: Perforation

  MAUDE report 9943859 ↗
• InjuryApr 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERFORATION OCCURRED. ON (B)(6) 2004, THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019, A COMPUTED TOMOGRAPHY (CT) SCAN OF THE ABDOMEN WITH CONTRAST WAS PERFORMED AND REVEALED THE INFERIOR VENA CAVA (IVC) FILTER WITH TINES MINIMALLY EXTENDING OUTSIDE IVC. NO SURROUNDING STRANDING WAS NOTICED. THERE WAS A POSITIVE MESENTERIC PERFORATION. RETRO-AORTIC LEFT RENAL VEIN NOTED WITH ONE OF THE TINES SLIGHTLY EXTENDING INTO THE LEFT VEIN.

  Patient problems: Perforation

  MAUDE report 9943787 ↗
• InjuryApr 9, 2020Positioning Problem; Positioning Problem

  ON (B)(6) 2007, THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THAT INFRARENAL INFERIOR VENA CAVA (IVC) FILTER NOTED WAS ANGLED AT APPROXIMATELY 10 DEGREES RELATIVE TO THE IVC. A FEW OF THE STRUTS APPEARED TO BE BENDING. ONE OF THE STRUTS WAS SEEN 2 MM FROM THE RIGHT IVC WALL. THE APEX OF THE FILTER ABUTS THE ANTERIOR WALL. IT WAS FURTHER REPORTED THAT THE PATIENT HAD THEIR CT SCAN ON (B)(6) 2018.

  Patient problems: Perforation

  MAUDE report 9943616 ↗
• InjuryApr 9, 2020Positioning Problem; Positioning Problem

  ON (B)(6) 2007 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019 A POSITIVE COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A SLIGHT TILT OF THE FILTER TO THE LEFT AND A MESENTERIC PERFORATION.

  Patient problems: Perforation

  MAUDE report 9943565 ↗