Bard Snare OUS SRK35Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00857834006551), received between May 23, 2017 and Jan 5, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Fluid/Blood Leak

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS INFERIOR VENA CAVA FILTER RETRIEVAL USING A SNARE RETRIEVAL KIT. DURING THE PROCEDURE, THE FLUID WAS ALLEGEDLY LEAKING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23968892 ↗
• MalfunctionOct 21, 2025Mechanical Problem; Mechanical Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS INFERIOR VENA CAVA FILTER RETRIEVAL USING A SNARE RETRIEVAL KIT. DURING THE PROCEDURE, THE SNARE LOOP ALLEGEDLY GOT CAUGHT ON THE FILTER LEG. IT WAS FURTHER REPORTED THAT A TIP MARKER FELL INTO THE BLOOD VESSEL. CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 23352111 ↗
• MalfunctionJul 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS INFERIOR VENA CAVA FILTER RETRIEVAL PROCEDURE USING A SNARE RETRIEVAL KIT. DURING THE PROCEDURE, THE MARK RING AT THE HEAD END OF THE FILTER BECAME DISLODGED. IT WAS FURTHER REPORTED THAT THE FILTER RETRIEVE SYSTEM WAS WITHDRAWN AS A WHOLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459350 ↗
• MalfunctionApr 28, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A VENA CAVA FILTER RETRIEVAL PROCEDURE, THE SHEATH OR VALVE COMPONENT WAS ALLEGEDLY DETACHED. IT WAS FURTHER REPORTED THAT THERE WAS A DIFFICULTY IN RETRACTING THE DEVICE THRU THE INTRODUCER SHEATH OR REMOVING FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21920072 ↗
• MalfunctionApr 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A VENA CAVA FILTER RETRIEVAL PROCEDURE, THE FRONT END OF THE LOOP LINE WAS ALLEGEDLY LOOSENING OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY'' '(B)(6) 2025 - IT WAS ORIGINALLY REPORTED IN THE EVENT DESCRIPTION, "PATIENT WAS ADMITTED TO THE HOSPITAL FOR LOWER EXTREMITY DEEP VEIN THROMBOSIS, PERFORMED "PERCUTANEOUS INFERIOR VENA CAVA FILTER REMOVAL", SELECTED MODEL SRK35 FILTER RECYCLER, THE OPERATOR'S OPERATING STANDARDS, IN THE PROCESS OF SENDING INTO THE BODY OF THE OPERATION OCCURS AT THE FRONT END OF THE LOOP LINE LOOSENING OFF, FAILED TO OPERATE TO TAKE OUT THE FILTER; OVERALL AFTER REMOVING THE FILTER, A NEW ONE WAS USED FOR THE OPERATION, AND THE OPERATION WENT SMOOTHLY, BUT THE OPERATOR SUSPECTED THAT THERE WAS A PRODUCT QUALITY MODE, AND REQUESTED TO FILE A COMPLAINT AND REPORT THE DAMAGE." THE EVENT DESCRIPTION WAS MODIFIED FOR CLARITY. THE DEVICE IS AVAILABLE FOR RETURN. CONFIRMED EVENT DATE WAS PRIOR TO EXPIRATION DATE IN JDE. EXPIRATION DATE FOR LOT 9017299808 IS 04/23/2027. A FOLLOW UP TASK CHILD WAS CREATED AND ASSIGNED TO THE IBC REQUESTING ADDITIONAL PATIENT AND PROCEDURAL DETAILS''. (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860698 ↗
• MalfunctionOct 17, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A FILTER REMOVAL PLACEMENT PROCEDURE, THE MARKER BAND OF THE 6F LOOP SNARE OF THE SNARE BECAME DETACHED AND FELL INTO THE INFERIOR VENA CAVA. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 20470610 ↗
• MalfunctionApr 16, 2024Mechanical Problem; Mechanical Problem

  ROUTINELY DISINFECT THE SKIN AND SPREAD STERILE DRAPE. AFTER SUCCESSFUL LOCAL ANESTHESIA WITH DOCAINE, PUNCTURE THE RIGHT JUGULAR VEIN USING THE SELDINGER METHOD AND INSERT. CONTRAST CATHETER, PERFORM INFERIOR VENA CAVA ANGIOGRAPHY, SEE THE INFERIOR VENA CAVA. THE VEINS ARE UNOBSTRUCTED, THE FILTER IS IN GOOD POSITION, AND THERE ARE NO THROMBI ATTACHED. INSTALL, REPLACE THE RECOVERY SHEATH, POSITION UNDER FLUOROSCOPY, AND APPLY THE CATCHER SUCCESSFULLY CAPTURED THE RECOVERY HOOK AND PUSHED IT FORWARD FOR RECOVERY SHEATH, RETRACT THE FILTER INTO THE SHEATH, AND RECYCLE THE FILTER SMOOTHLY AFTER WITHDRAWING, THE MARKING TAPE WAS FOUND TO HAVE FALLEN OFF, CAUSING ANOTHER THE IMAGE SHOWED THAT THE MARKER BAND WAS LOST TO THE HEART, AND DURING THE OPERATION BLEEDING IS ABOUT 10ML. PRESS THE PUNCTURE POINT FOR 15 MINUTES AFTER SURGERY. AFTERWARDS, THE PUNCTURE POINT WAS BANDAGED WITH PRESSURE. THE OPERATION WENT SMOOTHLY. THE PATIENT FELT NO DISCOMFORT AND RETURNED TO THE WARD SAFELY. SATURATIONDEGREE 99%, R 19 TIMES, MIN.

  Patient problems: Foreign Body In Patient

  MAUDE report 19120369 ↗
• MalfunctionNov 10, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A VENA CAVA FILTER RETRIEVAL PROCEDURE, WHEN THE TUNGSTEN-GOLD RING WAS PUSHED OUT OF THE RETRIEVAL CATHETER, THE MARKER BAND ALLEGEDLY FELL ONTO ONE ARM OF THE FILTER. IT WAS FURTHER REPORTED THAT THE FALLEN MARKER BAND ALLEGEDLY COULD NOT BE RETRIEVED WITH OTHER ALTERNATIVE METHODS. REPORTEDLY, GAVE SAFETY EVALUATION AND COMPREHENSIVE CONSIDERATIONS, THE FILTER WAS NOT RETRIEVED FOR THE TIME BEING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18116459 ↗
• MalfunctionJun 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE SNARE RETRIEVAL KIT WAS EXPECTED TO BE USED TO RETRIEVE THE DENALI FILTER PLACED IN THE INFERIOR VENA CAVA THROUGH THE RIGHT INTERNAL JUGULAR VEIN. WHEN PERFORMING RADIOGRAPH WITH THE 11 F INTRODUCER SHEATH OF THE RETRIEVAL KIT, LIQUID WAS FOUND LEAKING THE DISTAL END OF THE INTRODUCER SHEATH. THE SHEATH WAS REMOVED OUT OF THE BODY AND CAREFULLY EXAMINED AND A SMALL "BREACH" WAS FOUND. TO ENSURE THE SAFETY OF THE PATIENT DURING OPERATION, THE SNARE RETRIEVAL KIT WAS REPLACED WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17090973 ↗
• MalfunctionApr 27, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO THE SNARE RETRIEVAL PROCEDURE, AN OPENING WAS ALLEGEDLY FOUND AT THE EDGE OF THE SEAL. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16822734 ↗
• MalfunctionApr 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A VENA CAVA FILTER RETRIEVAL PROCEDURE, THE MARKER BAND OF THE SNARE AT THE PROXIMAL END ALLEGEDLY FELL OFF INTO THE VESSEL. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16796438 ↗
• MalfunctionNov 1, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A FILTER WAS PLACED IN THE VEIN OF THE LOWER EXTREMITY OF THE PATIENT WHERE THERE WAS THROMBUS. WHEN THE FILTER WAS RETRIEVED WITH THE SNARE RETRIEVAL KIT, THE MARKER FOR VISUALIZATION AT THE PROXIMAL CATHETER OF THE KIT FELL INTO THE POSTCAVA WALL OF THE PATIENT, WHICH COULD NOT BE REMOVED. THE DIRECTOR OF THE HOSPITAL NOTIFIED THE PATIENT OF THIS EVENT AND FUTURE OPERATION WILL DEPEND ON THE CONDITIONS OF THE PATIENT. IT WAS REPORTED THAT DURING A FILTER REMOVAL PROCEDURE, THE MARKER ALLEGEDLY DETACHED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 12728642 ↗
• InjuryMay 23, 2017Device Slipped; Device Slipped

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS POST FEMORAL DEPLOYMENT OF A VENA CAVA FILTER, A SNARE DEVICE WAS APPLIED TO THE FILTER AND CLOSED AND DRAWN INTO THE SHEATH SUCCESSFULLY. UPON RETRIEVAL OF THE INNER AND OUTER SHEATH, THE FILTER DISLODGED AND REMAINED AT THE JUGULAR INCISION. THE PATIENT WAS TRANSFERRED TO THE OR FOR SURGICAL INTERVENTION TO REMOVE THE FILTER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6584828 ↗