GreenfieldRecalls & reported problems across all models

We found 4 models of Greenfield by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 261 adverse event reports in the FDA's MAUDE database, received between Dec 20, 2017 and Nov 2, 2022 — classified as 226 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (166 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Greenfield problems

Greenfield models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Greenfield™ M001505010

  FILTER, INTRAVASCULAR, CARDIOVASCULAR
  113 reports
• Greenfield™ M001503010

  FILTER, INTRAVASCULAR, CARDIOVASCULAR
  64 reports
• Greenfield™ M001503000

  FILTER, INTRAVASCULAR, CARDIOVASCULAR
  55 reports
• Greenfield™ M001504000

  FILTER, INTRAVASCULAR, CARDIOVASCULAR
  29 reports

Recent Greenfield adverse event reports

The 15 most recent reports across all models, 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 28, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE FILTER WAS TILTED AND HAD PERFORATED THE SURROUNDING STRUCTURES. ON (B)(6), 2013, THE PATIENT WAS IMPLANTED WITH A GREENFIELD FILTER. THE PATIENT WAS PREVIOUSLY IMPLANTED WITH A TEMPORARY INFERIOR VENA CAVA (IVC) FILTER, WHICH WAS REMOVED AND REPLACED WITH A GREENFIELD FILTER. ON (B)(6), 2020, THE PATIENT RECEIVED AN ABDOMINAL CT SCAN TO EVALUATE THE PLACEMENT OF THE IVC FILTER. THE FILTER WAS OBSERVED TO BE TILTED LESS THAN 10 DEGREES. ADDITIONALLY, THE FILTER STRUTS HAD PERFORATED BEYOND THE IVC WALL, MAXIMALLY MEASURING 4 MM. NO ADJACENT ORGANS WERE SIGNIFICANTLY IMPACTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 15499696 ↗
• InjurySep 21, 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 MESENTERY. ON (B)(6) 2004, THE PATIENT WAS IMPLANTED WITH A GREENFIELD FILTER. ON (B)(6) 2019, THE PATIENT RECEIVED AN ABDOMINAL CT SCAN FOR AN UNSPECIFIED INJURY OF THE INFERIOR VENA CAVA (IVC). THE FILTER STRUTS WERE OBSERVED TO EXTEND BEYOND THE CONFINES OF THE IVC ON THE RIGHT SIDE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 15461928 ↗
• InjurySep 21, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE FILTER WAS TILTED AND HAD PERFORATED THE INFERIOR VENA CAVA (IVC). ON (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH A GREENFIELD FILTER. THE PATIENT HAD A HISTORY OF DEEP VENOUS THROMBOSIS (DVT). ON (B)(6) 2019, THE PATIENT RECEIVED AN ABDOMINAL CT SCAN TO EVALUATE THE PLACEMENT OF THE IVC FILTER. THERE WAS AN APPROXIMATE 19 DEGREE TILT TO THE RIGHT SIDE. THE FILTER STRUTS EXTENDED OUTSIDE THE CONFINES OF THE IVC, ESPECIALLY POSTERIORLY. THE MOST CENTRAL POSTERIOR STRUT EXTENDED TO THE VERTEBRAL BODY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 15461881 ↗
• InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FILTER WAS PERFORATING ADJACENT STRUCTURES. ON (B)(6), 2010, THE PATIENT WAS IMPLANTED WITH A GREENFIELD FILTER. THE PATIENT HAD A HISTORY OF DEEP VENOUS THROMBOSIS (DVT) WITH PULMONARY EMBOLISM. ON (B)(6) 2019, THE PATIENT RECEIVED AN ABDOMINAL AND PELVIC CT SCAN. THE STRUTS OF THE INFERIOR VENA CAVA (IVC) FILTER WERE NOTED TO HAVE PERFORATED THE IVC. ONE STRUT WAS PERFORATING PROXIMALLY INTO THE RIGHT GONADAL VEIN AND ANOTHER WAS ABUTTING THE POSTERIOR WALL OF THE THIRD PORTION DUODENUM. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 15454587 ↗
• InjurySep 13, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE FILTER WAS TILTED AND HAD PERFORATED THE MESENTERY. ON (B)(6) 2004, THE PATIENT WAS IMPLANTED WITH A GREENFIELD FILTER. ON (B)(6) 2018, THE PATIENT RECEIVED AN ABDOMINAL AND PELVIC CT SCAN TO EVALUATE INFERIOR VENA CAVA (IVC) FILTER PLACEMENT. THE ANTERIOR AND RIGHT LATERAL STRUTS OF THE FILTER WERE OBSERVED TO EXTEND SLIGHTLY BEYOND THE BORDERS OF THE IVC. THERE WAS NO TILT OBSERVED AT THIS TIME. ON (B)(6) 2020, THE PATIENT RECEIVED AN ABDOMINAL CT SCAN TO EVALUATE IVC FILTER PLACEMENT. THE UPPER APEX OF THE FILTER WAS TILTED ANTERIORLY AND TOWARD THE LEFT, ABUTTING THE LEFT ANTEROLATERAL IVC WALL. THE FILTER WAS TILTED 15 DEGREES OFF AXIS COMPARED WITH THE AXIS OF THE IVC. A SINGLE ANTERIOR TINE APPEARED TO PERFORATE THE IVC MINIMALLY. THERE WAS APPROXIMATELY 1 MM OF SEPARATION AT THE TIP OF THE TINE FROM THE ANTERIOR IVC WALL. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 15412492 ↗
• 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 ↗
• MalfunctionSep 8, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE DEVICE WAS TILTED. ON (B)(6), 2001, THE PATIENT WAS IMPLANTED WITH A GREENFIELD FILTER. THE PATIENT HAD A HISTORY OF DEEP VENOUS THROMBOSIS (DVT) IN THE RIGHT LOWER EXTREMITY. IN (B)(6)2022, IT WAS REPORTED THERE WAS EVIDENCE OF INFERIOR VENA CAVA (IVC) FILTER TILT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15381181 ↗
• InjurySep 6, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE FILTER WAS TILTED AND THAT THE STRUTS HAD PERFORATED THE INFERIOR VENA CAVA (IVC). ON (B)(6) 2012, THE PATIENT WAS IMPLANTED WITH A GREENFIELD FILTER. THE PATIENT WAS AT AN ELEVATED RISK OF DEVELOPING A PULMONARY EMBOLISM (PE) FOLLOWING A GASTRIC BYPASS SURGERY. ON (B)(6) 2020, THE PATIENT RECEIVED AN ABDOMINAL CT SCAN. IT WAS NOTED THAT THE IVC FILTER WAS TILTED WITH THE APEX OF THE FILTER CONTACTING THE RIGHT LATERAL WALL OF THE IVC. ONE OF THE FILTER STRUTS EXTENDED BEYOND THE WALL OF THE IVC LUMEN INTO THE ADJACENT RETROPERITONEAL FAT. ADDITIONAL, A FEW OF THE LEFT LATERAL STRUTS EXTENDED BEYOND THE IVC LUMEN, AND APPEARED TO ABUT THE ADJACENT AORTA. NO EVIDENCE OF STRUT FRACTURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 15362123 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INFERIOR VENA CAVA (IVC) FILTER HAD PERFORATED THE IVC. ON (B)(6) 2001, THE PATIENT WAS IMPLANTED WITH A GREENFIELD FILTER. ON (B)(6) 2019, THE PATIENT RECEIVED AN ABDOMINAL CT SCAN TO ASSESS IVC FILTER PLACEMENT. MULTIPLE PRONGS OF THE DISTAL PORTION OF THE DEVICE WERE LOCATED OUTSIDE THE LUMEN OF THE IVC, AND THE PROXIMAL PORTION WAS SEEN JUST ANTERIOR TO THE IVC.

  Patient problems: Perforation

  MAUDE report 15319618 ↗
• InjuryAug 25, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE DEVICE WAS TILTED AND HAD PERFORATED THE MESENTERY. ON (B)(6) 2003, THE PATIENT WAS IMPLANTED WITH A GREENFIELD FILTER. THE PATIENT WAS THE VICTIM OF A HIGH SPEED COLLISION WHICH RESULTED IN DAMAGE TO THE BILATERAL LOWER EXTREMITIES. ON (B)(6) 2019, THE PATIENT RECEIVED AN ABDOMINAL CT SCAN TO EVALUATE INFERIOR VENA CAVA (IVC) FILTER PLACEMENT. THERE WAS A MILD TILT OF THE LONG AXIS OF THE FILTER WITH THE CEPHALAD APEX ABUTTING THE ANTERIOR WALL OF THE IVC. THERE WAS EVIDENCE OF SEVERAL PERFORATED FILTER STRUTS. THERE WAS FILTER STRUT PERFORATION ALONG THE POSTERIOR LEFT LATERAL ASPECT EXTENDING INTO THE ADJACENT ADIPOSE TISSUE BY APPROXIMATELY 3 MM, ABUTTING THE ANTERIOR LONGITUDINAL LIGAMENT. THERE WAS FILTER STRUT PERFORATION ALONG THE ANTERIOR ASPECT OF THE IVC EXTENDING APPROXIMATELY 4 MM INTO THE ADJACENT ADIPOSE TISSUE. THERE WAS FILTER STRUT PERFORATION ALONG THE RIGHT LATERAL ASPECT OF THE IVC EXTENDING APPROXIMATELY 4 MM INTO THE ADJACENT ADIPOSE TISSUE. FINALLY, THERE WAS FILTER STRUT PERFORATION ALONG THE POSTERIOR ASPECT OF THE IVC EXTENDING APPROXIMATELY 5 MM INTO THE ADJACENT ADIPOSE TISSUES ABUTTING THE ANTERIOR LONGITUDINAL LIGAMENT. NO FUR

  Patient problems: Perforation

  MAUDE report 15299065 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE HAD PERFORATED THE INFERIOR VENA CAVA (IVC) AND WAS ABUTTING THE PANCREAS. ON (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH A GREENFIELD FILTER. THE PATIENT WAS EXPERIENCING DEEP VEIN THROMBOSIS (DVT) WITH ACUTE PULMONARY EMBOLISM DUE TO ANEMIA. IN (B)(6) 2018, THE PATIENT RECEIVED A CT SCAN. THE IVC FILTER WAS SHOWN WITH STRUT EROSION WITHOUT PENETRATION OF ADJACENT STRUCTURES. ONE OF THE STRUTS WAS SOMEWHAT CLOSE TO THE HEAD OF THE PANCREAS. ON (B)(6) 2019, THE PATIENT RECEIVED A PHYSICAL EXAM, DURING WHICH THE (B)(6) 2018 CT SCAN RESULTS WERE REVIEWED. THE FILTER STRUT EROSION WAS OBSERVED. DUE TO THE PATIENT'S HISTORY OF PARASTOMAL HERNIA AND STOMA, AND THE PATIENT NOT EXPERIENCING ANY SYMPTOMS, THE PHYSICIAN DID NOT RECOMMEND THAT THE FILTER BE REMOVED AT THAT TIME.

  Patient problems: Perforation

  MAUDE report 15298882 ↗
• InjuryAug 23, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE DEVICE HAD TILTED AND PERFORATED THE DUODENUM RESULTING IN BLEEDING. ON (B)(6) 1994, THE PATIENT WAS IMPLANTED WITH A GREENFIELD FILTER IN THE INFERIOR VENA CAVA (IVC). ON (B)(6) 2016, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH REPORTS OF DARK STOOL, RECTAL BLEEDING, DIZZINESS, AND WEAKNESS. THE PATIENT REPORTED THAT THEIR IVC FILTER HAD MIGRATED, BUT THAT THE LOCATION HAD NOT CHANGED ON A RECENT CT SCAN FROM 2 DAYS PRIOR. ON (B)(6) 2016, THE PATIENT UNDERWENT AN ENDOSCOPY PROCEDURE OF THE DUODENUM. THIS REVEALED A SHALLOW ULCER IN THE SECOND PORTION OF THE DUODENUM. IT WAS OBSERVED THAT A METAL WIRE TYPE STRUCTURE WAS PENETRATING THE DUODENAL WALL, WITH THE END RUBBING AT THE ULCER BED. REVIEW OF PAST CT INDICATED THE IVC FILTER LEG WAS EXTENDING INTO THE DUODENUM RESULTING IN GASTROINTESTINAL BLEEDING. SURGICAL REMOVAL OF THE FILTER WAS RECOMMENDED. ON (B)(6) 2016, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY IN ORDER TO REMOVE THE IVC FILTER AND REPAIR THE DUODENUM. THE LEFT RENAL VEIN WAS ISOLATED, AND THE RIGHT RENAL VEIN WAS SOMEWHAT ADHERED FROM INFLAMMATION WHERE THE TIP OF THE FILTER LIKELY RESTED. IN ADDITION TO THE TINE EXTENDING INTO TH

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 15279730 ↗
• InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FILTER STRUTS EXTENDED BEYOND THE INFERIOR VENA CAVA (IVC). ON (B)(6), 2012, THE PATIENT WAS IMPLANTED WITH THE GREENFIELD FILTER DUE TO CHRONIC LEFT LEG DEEP VEIN THROMBOSIS (DVT) WITH SUSPICION OF PULMONARY EMBOLUS. ON (B)(6), 2017, THE PATIENT RECEIVED AN ABDOMINAL AND PELVIC CT SCAN FOR REPORTED ABDOMINAL PAIN. THE FILTER WAS VISUALIZED WITH NO EVIDENCE OF TILT OR FRACTURED STRUTS. THE STRUTS WERE OBSERVED TO EXTEND BEYOND THE CONFINES OF THE IVC BY APPROXIMATELY 2 MM. TWO ANTERIOR STRUTS CLOSELY ABUTTED THE POSTERIOR WALL OF THE FOURTH PORTION OF THE DUODENUM AS IT TRANSITS ANTERIOR TO THE IVC AND AORTA. A SINGLE STRUT WAS OBSERVED TO EXTEND INTO THE FAT BETWEEN THE IVC AND AORTA, CLOSELY ABUTTING THE RIGHT LATERAL WALL OF THE AORTA. THE REMAINING STRUTS EXTENDED INTO THE PERI IVC FAT WITHOUT INVOLVEMENT OF ADJACENT ANATOMIC STRUCTURES. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 15271676 ↗

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