Cook Celect G34505Recalls & reported problems

Summary

The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI 10827002345055), received between Mar 8, 2016 and Sep 11, 2025 — classified as 1 death, 63 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (20 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Feb 14, 2022Terminated

   IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events

   Z-0876-2022 · Root cause: Labeling design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 131 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2025Device Tipped Over; Device Tipped Over

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE CELECT FILTER APPEARED FINE BEFORE INSERTION, BUT AFTER BEING INTRODUCED TO THE PATIENT, IT APPEARED SIGNIFICANTLY TILTED ON THE IMAGING SCREEN. AS A RESULT, THE DOCTOR HAD TO REMOVE IT AND REPLACE IT WITH A NEW FILTER TO ENSURE PATIENT SAFETY. PATIENT OUTCOME: NO HARM TO PATIENT REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23023487 ↗
• InjuryJan 13, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: FILTER DEPLOYMENT ON JUG, THE DEPLOYMENT RELEASE MECHANISM WAS GETTING CAUGHT ON THE FILTER HOOK WHILE THE PHYSICIAN WAS TRYING TO RELEASE THE FILTER. THE PROCEDURE WAS ABLE TO BE COMPLETED BY USING THE DEVICE. DUE TO THE EVENT, IT CAUSED THE FILTER TO TILT, THEREFORE THE PHYSICIAN HAD TO USE A COOK, GTRS-200-RB RETRIEVAL SET TO READJUST THE FILTER. THERE WERE NO ISSUES WHEN RELEASING FROM THE FEM SYSTEM AND LOADING ONTO THE JUG SYSTEM. RE-SHEATHING OVER THE FILTER WITH THE JUG SYSTEM WENT SMOOTHLY. PATIENT OUTCOME: THE PHYSICIAN HAD TO GO IN WITH A RETRIEVAL SET AND READJUST THE FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21136309 ↗
• InjuryJan 10, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ACCORDING TO THE INITIAL REPORTER: FILTER DEPLOYMENT ON JUG, THE DEPLOYMENT RELEASE MECHANISM WAS GETTING CAUGHT ON THE FILTER HOOK WHILE THE PHYSICIAN WAS TRYING TO RELEASE THE FILTER. THE PROCEDURE WAS ABLE TO BE COMPLETED BY USING THE DEVICE. THE EVENT IT CAUSED THE FILTER TO TILT, THEREFORE THE PHYSICIAN HAD TO USE A COOK, GTRS-200-RB RETRIEVAL SET TO READJUST THE FILTER. ADDITIONAL INFORMATION RECEIVED 23DEC2024: THERE WERE NO ISSUES WHEN RELEASING FROM THE FEM SYSTEM AND LOADING ONTO THE JUG SYSTEM. RE-SHEATHING OVER THE FILTER WITH THE JUG SYSTEM WENT SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21126761 ↗
• InjuryNov 11, 2024Premature Activation; Improper or Incorrect Procedure or Method; Premature Activation; Improper or Incorrect Procedure or Method

  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 20651024 ↗
• InjuryNov 5, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ACCORDING TO THE INITIAL REPORTER, THE FILTER WAS PLACED INCORRECTLY. THE LEAD TECH SAID THAT THE DOCTOR SAID IT MISFIRED. THE TECH SAID IT WAS MISPLACED. THEY TRIED TO RETRIEVE IT BUT WERE UNSUCCESSFUL. THE TOP IS IN THE COMMON AND THE PRONGS ARE IN THE RIGHT INTERNAL. THEY WILL ATTEMPT AGAIN TO RETRIEVE IT WITHIN THE NEXT FEW WEEKS. ADDITIONAL INFORMATION RECEIVED: - WAS THE FILTER ADVANCED BY FEMORAL OR JUGULAR INTRODUCER? FEMORAL - WERE THE DIFFICULTIES AT DEPLOYMENT DUE TO THE HANDLE (BLUE RELEASE BUTTON)? NOT THE HANDLE. THE FILTER WAS NOT FULLY INTRODUCED. - WAS THE RETRIEVAL PROCEDURE BY USING GTRS? THE SNARE WAS IN THE RETRIEVAL KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20616003 ↗
• InjuryOct 7, 2024Premature Activation; Premature Activation

  ACCORDING TO THE INITIAL REPORTER: A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT AN IVC FILTER PLACEMENT PROCEDURE IN WHICH THE COOK SELECT PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET, G34505, WAS USED. WHEN ADVANCING THE CATHETER, THE FILTER DEPLOYED ON ITS OWN. THE PHYSICIAN HAD TO GO IN WITH A RETRIEVAL KIT TO REMOVE THE FILTER AND FINALLY USED ANOTHER FILTER WHICH WORKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20390010 ↗
• InjuryOct 7, 2024Premature Activation; Improper or Incorrect Procedure or Method; Premature Activation; Improper or Incorrect Procedure or Method

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT AN INFERIOR VENA CAVA (IVC) FILTER PLACEMENT PROCEDURE IN WHICH THE COOK CELECT PLATINUM NAVALIGN UNISET, WAS USED. WHEN ADVANCING THE CATHETER, THE FILTER DEPLOYED ON ITS OWN. THE PHYSICIAN HAD TO GO IN WITH A RETRIEVAL KIT TO REMOVE THE FILTER AND FINALLY USED ANOTHER FILTER WHICH WORKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20381694 ↗
• InjuryOct 7, 2024Improper or Incorrect Procedure or Method; Material Split, Cut or Torn; Improper or Incorrect Procedure or Method; Material Split, Cut or Torn

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A FEMALE PATIENT OF UNDISCLOSED AGE WAS TO UNDERGO A PROCEDURE TO REPAIR A HIP FRACTURE, AND THE PHYSICIAN WAD PLACING A FILTER AS A SUBSEQUENT PROCEDURE. THE PHYSICIAN GAINED ACCESS IN THE LEFT FEMORAL VEIN. WHILE ADVANCING THE FILTER PERFORATED THE SHEATH. THE NURSE MANAGER BELIEVES IT DEPLOYED IN THE ILIAC VEIN, ALTHOUGH THERE ARE NO IMAGES TO CONFIRM. THE PHYSICIAN STATED THE SHEATH MAY HAVE GOT CAUGHT ON THE ILIAC VEIN. THE PATIENT WAS TRANSFERRED TO A SISTER FACILITY TO AN INTERVENTIONAL RADIOLOGIST. INFORMATION RECEIVED ON 28AUG2024. THE INTRODUCER BECAME KINKED CAUSING THE FILTER TO PROTRUDE OUT THROUGH THE SIDE OF THE SHEATH AND CAUSING MISPOSITIONING OF THE FILTER IN THE LEFT ILIAC VEIN. TORTUOUS INFERIOR VENA CAVA WITH THE RIGHT RENAL COMING OFF AT A VERY ACUTE ANGLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20381676 ↗
• InjuryAug 6, 2024Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Material Split, Cut or Torn; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Material Split, Cut or Torn

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE SHEATH OF THE FILTER SHEATH BROKE INTO COMING FROM THE LEFT INTERNAL JUGULAR AT AN ACUTE ANGLE, BROKE INTO AND RETRIEVED WITH A BALLOON CATHETER. THEY USED ANOTHER UNI-CELECT IVC FILTER AND THEY WERE SUCCESSFUL. THERE WAS NO PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19916883 ↗
• InjuryAug 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE INITIAL REPORTER: "THE SHEATH OF THE FILTER SHEATH BROKE INTO COMING FROM THE LEFT INTERNAL JUGULAR AT AN ACUTE ANGLE, BROKE INTO AND RETRIEVED WITH A BALLOON CATHETER. THEY USED ANOTHER UNI-CELECT IVC FILTER AND THEY WERE SUCCESSFUL. THERE WAS NO PATIENT COMPLICATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19905932 ↗
• InjuryJul 23, 2024Difficult to Remove; Structural Problem; Appropriate Device Problem Term/Code Not Available; Difficult to Remove; Structural Problem; Appropriate Device Problem Term/Code Not Available

  PATIENT ALLEGEDLY RECEIVED A COOK CELECT PLATINUM FILTER VIA THE FEMORAL VEIN DUE TO PULMONARY EMBOLISM (PE) AND DEEP VEIN THROMBOSIS (DVT). PATIENT IS ALLEGING LAPAROSCOPIC FILTER RETRIEVAL, HEMORRHAGIC SHOCK DUE TO PERFORATION OF IVC AND LUMBAR ARTERY. IT IS ALSO ALLEGED THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH COMPLICATIONS OF BACK PAIN AND SHORTNESS OF BREATH. PATIENT WAS FOUND TO HAVE A LARGE RETROPERITONEAL HEMATOMA SECONDARY TO IVC FILTER PERFORATING THE IVC STATUS POST EXPLORATORY LAPAROTOMY, LIGATION OF LUMBAR ARTERY, REPAIR OF THE IVC AND RIGHT RENAL VEIN, VENOTOMY AND IVC FILTER EXTRACTION. PATIENT WAS TREATED FOR HEMORRHAGIC SHOCK AND ACUTE RESPIRATORY FAILURE. FILTER RETRIEVAL DATE IS UNKNOWN.

  Patient problems: Dyspnea; Hematoma; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Pain; Perforation of Vessels; Respiratory Failure; Retroperitoneal Hemorrhage; Shock

  MAUDE report 19807865 ↗
• MalfunctionJan 15, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  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 18510408 ↗
• InjurySep 19, 2023Difficult to Remove; Obstruction of Flow; Appropriate Device Problem Term/Code Not Available; Difficult to Remove; Obstruction of Flow; Appropriate Device Problem Term/Code Not Available

  IT IS ALLEGED THAT PATIENT RECEIVED COOK CELECT PLATINUM INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2018 DUE TO BROKEN ANKLE WITH CLOTTING FOLLOWED BY AN UNSUCCESSFUL, PERCUTANEOUS RETRIEVAL ATTEMPT ON (B)(6) 2018. THE PATIENT IS ALLEGING THROMBOSIS AND DEVICE IS UNABLE TO BE RETRIEVED. PATIENT ALSO EXPERIENCED LOWER BACK AND LEG PAIN, LEG/FEET SWELLING, SHORTNESS OF BREATH, LOSS OF APPETITE, NUMBNESS IN TOES, DIZZINESS, STOMACH SWOLLEN, CRAMPING NEAR GROIN AREA AND LIMITED ACTIVITY. PER FILTER RETRIEVAL REPORT (UNSUCCESSFUL ATTEMPT): "FINDINGS: THE HOOK OF THE PATIENT'S FILTER WERE NOT COMING LOOSE FROM THE IVC AND THEREFORE WE ELECTED TO LEAVE THE FILTER IN PLACE." PER REPORT FROM VENOGRAM: "PREOPERATIVE DIAGNOSIS: THROMBOSIS OF THE INFERIOR VENA CAVA WITH EXTENSIVE BILATERAL LOWER EXTREMITY DEEP VENOUS THROMBOSES". "OPERATION: 1. BILATERAL LOWER EXTREMITY VENOGRAM AND INFERIOR VENACAVOGRAM VIA ULTRASOUND-GUIDED BILATERAL POPLITEAL VENOUS ACCESS 2. PTA OF THE IVC, BILATERAL COMMON ILIAC VEINS, BILATERAL EXTERNAL ILIAC VEINS, BILATERAL COMMON FEMORAL VEINS, AND BILATERAL FEMORAL VEINS USING 8 MM MUSTANG BALLOON 3. PLACEMENT OF BILATERAL 50 CM EKOS THROMBOLYSIS CATHETER EXTENDING FR

  Patient problems: Abdominal Pain; Cramp(s) /Muscle Spasm(s); Decreased Appetite; Dizziness; Dyspnea; Insufficient Information; Numbness; Pain; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 17772908 ↗
• InjuryAug 30, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE PHYSICIAN HAD SOME CHALLENGES WITH A FILTER DEPLOYMENT. THE FILTER DID NOT DEPLOY AS EXPECTED AND SUBSEQUENTLY THERE WAS AN ISSUE WITH THE SHEATH. PATIENT OUTCOME: THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: Insufficient Information

  MAUDE report 17648849 ↗
• InjuryMay 16, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Pain

  MAUDE report 16937867 ↗
• InjuryMay 15, 2023Failure to Advance; Failure to Advance

  ADDITIONAL INFORMATION RECEIVED 15MAY2023: JUGULAR APPROACH WAS USED IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16928566 ↗
• InjuryMay 12, 2023Failure to Advance; Failure to Advance

  ADDITIONAL INFORMATION RECEIVED 15MAY2023: JUGULAR APPROACH WAS USED IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16918180 ↗
• InjuryMay 11, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ACCORDING TO THE INITIAL REPORTER, FEMORAL ACCESS, SHEATH PLACED TO SUPRARENAL IVC, FILTER LOADED BUT NOT DEPLOYED ORIGINALLY. ONCE FILTER LOADED INTO THE SHEATH, AS [THE PHYSICIAN] WAS PULLING DOWN THE SHEATH TO INFRARENAL LOCATION, THE SHEATH GOT ¿STUCK¿ AND PATIENT COMPLAINED OF PAIN. TRIED TO REPOSITION SHEATH BUT THE SHEATH COULD NOT BE PULLED DOWN FURTHER. THEN THE HOOK OF FILTER WAS EXPOSED AND SUBSEQUENTLY FILTER PARTIALLY DEPLOYED, IN SUPRARENAL LOCATION. THEN [THE PHYSICIAN] GOT IJ ACCESS AND WAS ABLE TO RETRIEVE THE FILTER FROM SUPRARENAL LOCATION. SOME FIBRINOUS MATERIAL WAS SEEN AROUND THE HOOK OF THE FILTER. THEN [THE PHYSICIAN] EXCHANGED FOR A NEW FILTER SHEATH, DEPLOYED A NEW FILTER IN INFRARENAL LOCATION WITHOUT DIFFICULTY.

  Patient problems: Pain

  MAUDE report 16912443 ↗
• InjuryMar 17, 2023Structural Problem; Device Tipped Over; Unintended Movement; Appropriate Device Problem Term/Code Not Available; Structural Problem; Device Tipped Over; Unintended Movement; Appropriate Device Problem Term/Code Not Available

  PATIENT ALLEGEDLY RECEIVED THE CELECT PLATINUM FILTER VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE) FOLLOWED BY SUCCESSFUL PERCUTANEOUS FILTER RETRIEVAL (B)(6) 2022. PATIENT IS ALLEGING DEVICE MIGRATION AND TILT, VENA CAVA PERFORATION, PAIN AND SUFFERING. PATIENT NOTES AND FURTHER ALLEGES EXPERIENCING ABDOMINAL PAIN WHILE BENDING FORWARD AND ANXIETY. PER THE SUCCESSFUL IVC FILTER RETRIEVAL: "PATIENT PRESENTS FOR IVC FILTER RETRIEVAL. OF NOTE, FILTER IS MALPOSITIONED WITH MEDIAL TILT AND SUPRARENAL LOCATION ON PRIOR CT". "THIS DEMONSTRATED A PATENT VENA CAVA WITH GOOD FLOW. NO FILLING DEFECT WITHIN THE IVC FILTER TO SUGGEST THROMBUS. HOWEVER, THE IVC FILTER WAS NOTED TO BE SUPRARENAL IN POSITION WITH MEDIAL TILTING OF THE APICAL HOOK". "...MULTIPLE ATTEMPTS WERE MADE TO GRASP THE HOOK ON THE FILTER WITHOUT SUCCESS GIVEN THE MEDIALLY DEVIATED POSITION OF THE HOOK". "...THE BENTSON GUIDEWIRE WAS ADVANCED THROUGH THIS CATHETER, THUS FORMING A LOOP AROUND THE IVC FILTER AFTER REMOVAL OF THE CATHETER. THE DISTAL END OF THIS LOOP WAS GRASPED WITH THE SNARE DEVICE AND THE FILTER WAS THEN OVER-SHEATHED AND THEN REMOVED ALONG WITH THE SHEAT

  Patient problems: Abdominal Pain; Anxiety; Insufficient Information; Perforation of Vessels

  MAUDE report 16565154 ↗
• InjuryFeb 6, 2023Structural Problem; Appropriate Device Problem Term/Code Not Available; Structural Problem; Appropriate Device Problem Term/Code Not Available

  IT IS ALLEGED THAT THE PATIENT RECEIVED A CELECT PLATINUM (PT) INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2014, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

  Patient problems: Insufficient Information; Internal Organ Perforation; Perforation of Vessels

  MAUDE report 16302923 ↗
• MalfunctionJan 30, 2023Difficult or Delayed Activation; Difficult or Delayed Activation

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE DEPLOYMENT MECHANISM WOULD NOT DEPLOY THE FILTER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. PATIENT OUTCOME: 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 16263003 ↗
• InjuryJan 19, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: WENT TO PUT THE FILTER ON THE JUGULAR ACCESS AND UPON DEPLOYMENT THE HOOK HAD NOT BEEN CAPTURED. THEREFORE, IT MAL-DEPLOYED. PATIENT OUTCOME: THE FACILITY HAD TO BRING THE PATIENT BACK TO RETRIEVE THIS FILTER (COMPLAINT DEVICE). AFTER THE FILTER WAS RETRIEVED, NEW FILTER WAS PLACED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16203450 ↗
• InjuryJan 11, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: WENT TO PUT THE FILTER ON THE JUGULAR ACCESS AND UPON DEPLOYMENT THE HOOK HAD NOT BEEN CAPTURED. THEREFORE, IT MAL-DEPLOYED. PATIENT OUTCOME: THE FACILITY HAD TO BRING THE PATIENT BACK TO RETRIEVE THIS FILTER (COMPLAINT DEVICE). AFTER THE FILTER WAS RETRIEVED, NEW FILTER WAS PLACED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16135877 ↗
• DeathNov 28, 2022Inadequate Filtration Process; Obstruction of Flow; Detachment of Device or Device Component; Inadequate Filtration Process; Obstruction of Flow; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION IS ALLEGED: THE DECEDENT RECEIVED A CELECT PLATINUM (PT) INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2016 DUE TO MULTIPLE ACUTE OCCLUSIVE DEEP VEIN THROMBOSIS (DVT) AND TO PREVENT FUTURE DVT/PULMONARY EMBOLISM (PE). THE DECEDENT REPORTEDLY EXPIRED ON (B)(6) 2020 DUE TO THROMBUS AS A RESULT OF A FRACTURED FILTER WHICH, ALLEGEDLY, CAUSED FATAL PE. THE PLAINTIFF IS ALLEGING WRONGFUL DEATH. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

  Patient problems: Dyspnea; Pain; Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 15870759 ↗
• InjuryNov 28, 2022Difficult to Remove; Structural Problem; Device Tipped Over; Unintended Movement; Appropriate Device Problem Term/Code Not Available; Difficult to Remove; Structural Problem; Device Tipped Over; Unintended Movement; Appropriate Device Problem Term/Code Not Available

  IT IS ALLEGED THAT THE PATIENT RECEIVED A CELECT PLATINUM (PT) INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2020, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

  Patient problems: Anxiety; Coma; Device Embedded In Tissue or Plaque; Distress; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Internal Organ Perforation; Myocardial Infarction; Pain; Perforation of Vessels

  MAUDE report 15870309 ↗