TRUFILL 635-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10886704029410), received between Aug 15, 2017 and Mar 29, 2021 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (14 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 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT WHEN THE TRUFILL DCS SYRINGE II (635002 / 96331359) WAS BEING PREPPED WITH SALINE, A LEAK WAS FOUND ON THE SYRINGE. IT WAS REPORTED THAT THE PROCEDURE WAS NOT DELAYED DUE TO THE REPORTED EVENT; IT WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11582311 ↗
• MalfunctionFeb 18, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN FELT WATER LEAKING DURING THE ATTEMPT TO DETACH THE COIL USING THE TRUFILL DCS SYRINGE II (635002 / 96331353). THE PHYSICIAN REPLACED IT WITH ANOTHER TRUFILL DCS SYRINGE II, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. A COMMENT MADE WAS THAT THE TRUFILL WAS DIFFICULT TO USE BECAUSE ¿WATER KEEPS LEAKING OUT.¿ THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11345240 ↗
• MalfunctionFeb 4, 2021Crack; Fluid/Blood Leak; Difficult or Delayed Separation; Crack; Fluid/Blood Leak; Difficult or Delayed Separation

  AS REPORTED BY THE FIELD, DURING A STENT-ASSISTED ANEURYSM EMBOLIZATION, THE TRUFILL DCS SYRINGE II (635002, 96331354) DID NOT PRESSURIZE AS INTENDED. THERE WAS A CRACK ON THE TIP OF THE WIRE, THE SYRINGE IS UNDER AIR LEAKAGE. THE UNSPECIFIED COIL SYSTEM COULDN'T BE DETACHED. THE PHYSICIAN SWITCHED TO ANOTHER SYRINGE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO INJURY REPORTED. THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY DIFFICULTY. THE SYRINGE WAS FILLED WITH SALINE FROM A DEDICATED SOURCE OF SALINE. THE SYRINGE HAD NOT BEEN USED TO SUCCESSFULLY DETACH ANY COILS PRIOR TO THIS ONE. PRIOR TO ATTEMPTING TO DETACH, IT WAS VERIFIED UNDER FLUORO THAT THERE WAS NO STRESS AGAINST THE HEADWAY17 MICROCATHETER (MC) OR DELIVERY TUBE. THE SAME SYRINGE HAD NOT PREVIOUSLY EXCEEDED THE GREEN ZONE/POSITION #3. AFTER THE COIL DID NOT DETACH AT THE SYRINGE GREEN ZONE, IT WAS NOT ATTEMPTED TO DEPLOY THE COIL AT THE SYRINGE RED ALTERNATIVE DETACHMENT ZONE. SUBSEQUENT COILS WERE DETACHED WITH ANOTHER SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11279510 ↗
• MalfunctionJan 25, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN FELT WATER LEAKING DURING THE ATTEMPT TO DETACH THE COIL USING THE TRUFILL DCS SYRINGE II (635002 / 96331358). THE PHYSICIAN REPLACED IT WITH ANOTHER TRUFILL DCS SYRINGE II, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. A COMMENT MADE WAS THAT THE TRUFILL WAS DIFFICULT TO USE BECAUSE ¿WATER KEEPS LEAKING OUT.¿ THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11227120 ↗
• MalfunctionJan 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE FIELD, A TRUFILL DCS SYRINGE II (635002, 96331363) LEAKS AIR. IT WAS NOTED THAT THE SYRINGE COULDN'T MAKE AN UNKNOWN COIL DETACHED DUE TO THE AIR LEAKAGE. THE PHYSICIAN SWITCHED TO A NEW SYRINGE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. A PICTURE WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11193468 ↗
• MalfunctionJan 14, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN FELT WATER LEAKING DURING THE ATTEMPT TO DETACH THE COIL USING THE TRUFILL DCS SYRINGE II (635002 / 96331357). THE PHYSICIAN REPLACED IT WITH ANOTHER TRUFILL DCS SYRINGE II, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11174776 ↗
• MalfunctionDec 16, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN FELT WATER LEAKING DURING THE ATTEMPT TO DETACH THE COIL USING THE TRUFILL DCS SYRINGE II (635002 / 96331358). THE PHYSICIAN REPLACED IT WITH ANOTHER TRUFILL DCS SYRINGE II, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. A COMMENT MADE WAS THAT THE TRUFILL WAS DIFFICULT TO USE BECAUSE ¿WATER KEEPS LEAKING OUT.¿ THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT, OR COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11024409 ↗
• MalfunctionDec 2, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE FIELD, DURING THE USE OF A TRUFILL DCS SYRINGE II (635002, 96331358), THE PHYSICIAN FELT WATER LEAKS OUT DURING THE DETACHMENT OF AN UNSPECIFIED COIL. THE PHYSICIAN USED A SAME LIKE PRODUCT AND THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10934935 ↗
• MalfunctionDec 2, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE FIELD, DURING THE USE OF A TRUFILL DCS SYRINGE II ((B)(4)), THE PHYSICIAN FELT WATER LEAKS OUT DURING THE DETACHMENT OF AN UNSPECIFIED COIL. THE PHYSICIAN USED A SAME LIKE PRODUCT AND THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10934803 ↗
• MalfunctionNov 9, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT PRIOR TO THE STENT-ASSISTED COIL EMBOLIZATION PROCEDURE, WHEN THE PACKAGE FOR THE TRUFILL DCS SYRINGE II (635002 / 96331361) WAS BEING OPENED, SOME WHITE FLAKES WERE OBSERVED IN THE PACKAGE. THE DEVICE WAS NOT USED IN THE PATIENT; THE FOREIGN FLAKES WERE FOUND AS SOON AS THE PACKAGE WAS OPENED. ADDITIONAL INFORMATION PROVIDED INDICATED THAT THERE WAS NO ISSUE WITH THE PACKAGING, THE INNER BAG WAS FIRMLY SEALED. THE WHITE FLAKES WERE FOUND IN THE STERILE BAG; THE FOREIGN FLAKES WAS REPORTED TO BE CLEARLY SEEN AS WHITE FLAKES. THE PHYSICIAN USED ANOTHER DEVICE FOR THE PROCEDURE; THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. A PHOTO OF THE DEVICE PACKAGING WAS INCLUDED WITH THE REPORTED FLAKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10812423 ↗
• MalfunctionAug 31, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN FELT WATER LEAKING DURING THE ATTEMPT TO DETACH THE COIL USING THE TRUFILL DCS SYRINGE II (635002 / 96331354). THE PHYSICIAN REPLACED IT WITH ANOTHER TRUFILL DCS SYRINGE II, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10471961 ↗
• MalfunctionAug 31, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN FELT WATER LEAKING DURING THE ATTEMPT TO DETACH THE COIL USING THE TRUFILL DCS SYRINGE II (635002 / 96331354). THE PHYSICIAN REPLACED IT WITH ANOTHER TRUFILL DCS SYRINGE II, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10471942 ↗
• MalfunctionAug 31, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN FELT WATER LEAKING DURING THE ATTEMPT TO DETACH THE COIL USING THE TRUFILL DCS SYRINGE II (635002 / 96331357). THE PHYSICIAN REPLACED IT WITH ANOTHER TRUFILL DCS SYRINGE II, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10471902 ↗
• MalfunctionNov 6, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN INTRACRANIAL ARTERY ANEURYSM, A LEAKAGE WAS NOTED FROM THE PROXIMAL TUBE OF THE TRUFILL DCS SYRINGE II (635002/(B)(4)). ADDITIONAL INFORMATION RECEIVED INDICATED THE FOLLOWING: ¿PERFORMER LINE SPRING COIL EMBOLIZATION, SELECT DETACHABLE COIL TO FILL, FILL AFTER USING SYRINGE FOR RELIEF. EXHAUST, ACCORDING TO STANDARDIZED OPERATION TO OPEN THE SYRINGE FOUND LIQUID SEEPING OUTWARD PROXIMAL BRAIDED TUBE, CHECK FOUND A CREVASSE SYRINGE PROXIMAL BRAIDED TUBE, THEN SWITCH TO OTHER SYRINGES.¿ THE SYRINGE WAS REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PRODUCT WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8044488 ↗
• MalfunctionOct 1, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF A PULMONARY ANEURYSM AND ARTERIOVENOUS FISTULA (AVF), SALINE LEAKED FROM THE JUNCTION OF THE TIP TUBE AND THE GAUGE PART OF THE TRUFILL DCS SYRINGE II (635002 / 96331305) AND AS A RESULT, THE SYRINGE COULD NOT BE PRESSURIZED. THE SYRINGE WAS REPLACED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SYRINGE GOT CRACKED. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. IT WAS REPORTED THAT THE TRUFILL DCS SYRINGE II IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7922833 ↗
• MalfunctionJul 3, 2018Leak/Splash; Leak/Splash

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN UNSPECIFIED ANEURYSM, THE UNSPECIFIED COIL WAS BEING PRESSURIZED FOR DETACHMENT WITH A TRUFILL DCS SYRINGE II (635002/UNK) WHEN A LEAKAGE WAS NOTED FROM THE CONNECTION. THE SYRINGE WAS SUBSEQUENTLY REPLACED. THE SAME COIL COULD BE DETACHED WITH THE REPLACEMENT SYRINGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO AND FOLLOWING THE EVENT. THE SYRINGE WAS PREPPED FOLLOWING IFU INSTRUCTIONS. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE USER DID NOT APPLY EXCESSIVE FORCE WHEN HANDLING THE DEVICE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7661625 ↗
• MalfunctionJun 20, 2018Leak/Splash; Leak/Splash

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM, THE TRUFILL DCS SYRINGE (635002/96331305) WAS TAKEN OUT OF THE PACKAGE TO BE PRIMED; AFTER ASPIRATING SALINE IN THE SYRINGE, IT WAS CONNECTED TO THE COIL HUB FOR PRIMING AND PRESSURE WAS APPLIED WHEN A LEAK WAS FOUND AT THE CONNECTION BETWEEN THE SYRINGE AND THE TUBE TIP. THE TRUFILL SYRINGE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7623536 ↗
• MalfunctionMar 27, 2018Leak/Splash; Leak/Splash

  AS REPORTED BY AN AFFILIATE, DURING RETREATMENT OF RECANALIZED ANEURYSM, A GALAXY COIL (3X6) WAS ATTEMPTED TO DETACH WITH A TRUFILL DCS SYRINGE II ((B)(4)). THE PHYSICIAN TRIED TO DETACH THE COIL TWO TIMES BUT THE ISSUE CONTINUED. THE LEAKAGE WAS FOUND FROM THE HUB PART BEFORE PERFORMING THE ALTERNATIVE. THEREFORE, THE SYRINGE WAS REPLACED WITH ANOTHER ONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO PATIENT INJURY OR COMPLICATIONS REPORTED. THE PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO THE EVENT. A MICRO CATHETER (SL10,STRYKER) WAS ALSO USED FOR THIS PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7375232 ↗
• MalfunctionAug 15, 2017Compatibility Problem; Compatibility Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A TRUFILL DCS SYRINGE (635-002/96331291) WAS NOT FIRMLY CONNECTED AT THE LUER CONNECTOR DURING AN EMERGENCY GASTROINTESTINAL BLEED COIL EMBOLIZATION PROCEDURE AS THE KNOB OF THE SYRINGE COULD NOT BE TURNED. THE MICROCATHETER WAS ADVANCED TO THE TARGET LESION AND COIL EMBOLIZATION BEGAN WITH A GALAXY COIL WITH THE TRUFILL DCS SYRINGE (COMPLAINT PRODUCT). THE LUER CONNECTOR WAS NOT FIRMLY CONNECTED DURING PLACEMENT OF THE COIL AND THE SYRINGE WAS REPLACED WITH ANOTHER ONE. THE GALAXY COIL WAS THEN SUCCESSFULLY DETACHED. THE PATIENT WAS A MALE, AGE UNKNOWN. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WERE ALSO UNKNOWN. NO REPORT OF OTHER DEVICES USED DURING THE PROCEDURE IS AVAILABLE. THERE WAS NO DAMAGE NOTED TO THE SYRINGE PRIOR TO USE AND IT WAS FILLED WITH SALINE FROM A DEDICATED SOURCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES AND THERE WAS NO DELAY IN PROCEDURE. THERE WAS ALSO NO PATIENT INJURY/COMPLICATION REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6794370 ↗