Needle's Eye G26517Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00827002265172), received between May 6, 2016 and Nov 12, 2025 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING REMOVAL OF A BOSTON SCIENTIFIC RELIANCE CD LEAD, WHICH HAD BEEN IN PLACE ON THE RIGHT SIDE FOR 17 YEARS, LOCKING WAS NOT ACHIEVED AT ALL, SO A TANDEM APPROACH WAS SELECTED FOR THE PROCEDURE. AFTER GRASPING THE LEAD WITH NES, BLOOD PRESSURE GRADUALLY DECREASED. CARDIAC TAMPONADE WAS SUSPECTED, SO DRAINAGE OF PERICARDIAL FLUID WITH BLOOD WAS PERFORMED. AFTER OBSERVING THE PATIENT FOR A WHILE, THE LEAD REMOVAL PROCEDURE WAS RESUMED.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 23536203 ↗
• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE EVENT OCCURRED DURING THE PROCEDURE. THE PATIENT: FEMALE, 80S YEARS OLD. THE LEAD IMPLANTED IN THE RIGHT VENTRICLE WAS REMOVED WITH A NEEDLE'S EYE SNARE FROM THE RIGHT INGUINAL. THE TIP OF THE LEAD IMPLANTED IN THE RIGHT ATRIUM CAME OFF BY PULLING FROM THE UPPER EXTREMITY, THEREFORE, THE NEEDLE'S EYE SNARE, WHICH HAD BEEN USED FOR RIGHT VENTRICLE. WAS ATTEMPTED TO BE USED TO GRASP. HOWEVER, SEVERAL ATTEMPTS TO GRASP FAILED THOUGH THE NEEDLE'S EYE SNARE WAS ABLE TO TOUCH THE LEAD. THE OPERATOR NOTICED THE BLOOD PRESSURE DROPPING, AND IT WAS SUSPECTED THAT CARDIAC TAMPONADE OCCURRED. PERICARDIOCENTESIS WAS DONE, AND THE BLOOD PRESSURE RECOVERED THOUGH MUCH BLOOD AS EXPECTED WAS NOT DRAWN OUT. TRANSFUSION WAS DECIDED NOT TO BE DONE BY ANESTHESIOLOGY DEPARTMENT BECAUSE THE HEMODYNAMICS BECAME STABLE TO DECIDE TO REMOVE THE LEAD IN ATRIUM. THE NEEDLE'S EYE SNARE WAS REPLACED WITH AN EN SNARE (MMJ) TO GRASP THE LEAD IN ATRIUM TO REMOVE FROM THE RIGHT INGUINAL. THE PATIENT CONDITION AFTER THE PROCEDURE: STABLE. AS IT WAS NOT UNSURE WHICH PART WAS DAMAGED, THE OPERATOR DISCUSSED WITH VASCULAR SURGERY TO DETERMINE IF SMALL THORACOTOMY SHOULD BE DONE TO REMOVE CLOTS,

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 21364518 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ANATOMY BEFORE SURGERY AND AT THE TIME OF FAILURE: PACEMAKER LEADS HAD BEEN PLACED FROM THE LEFT SUBCLAVIAN VEIN TO THE RIGHT ATRIUM AND RIGHT VENTRICLE RESPECTIVELY. THIS WAS A CASE OF LEAD EXTRACTION APPROACHED FROM THE RIGHT FEMORAL VEIN TO THE RIGHT VENTRICLE. THE USER INSERTED LR-NES002 FROM THE RIGHT FEMORAL VEIN AND GRASPED THE LEAD WITH THE SNARE AND PULLED THE LEAD WITH THE TIP ELECTRODE INTO THE 16FR SHEATH. THEN HE PULLED THE SNARE, AND THE TIP ELECTRODE OF THE LEAD GOT CAUGHT SOMEWHERE/SOMETHING IN THE 16FR SHEATH AND SEVERED. THE SEVERED TIP ELECTRODE OF THE LEAD ENTERED THE RENAL VEIN. THE PHYSICIAN DID NOT ATTEMPT TO REMOVE THE SEVERED TIP IN THE RENAL VEIN TRANSVENOUSLY BECAUSE IT WAS DETERMINED THAT THE OBJECT WAS TOO SMALL, THERE WAS NO DEVICE THAT COULD ENTER THE RENAL VEIN, AND THERE WERE POSSIBLE SECONDARY ADVERSE EVENTS IF HE TRIED TOO HARD. HE DECIDED TO MONITOR THE PATIENT. LEAD EXTRACTION WAS COMPLETED. UPDATED ON 12SEP2024: REP'S COMMENT ABOUT THE CAUSE OF BREAKAGE: THE CAUSE IS A PROCEDURAL ISSUE, AND I DON'T THINK THE PHYSICIAN BELIEVES THAT THE COOK PRODUCT WAS THE DIRECT CAUSE OF THE PROBLEM.

  Patient problems: Foreign Body In Patient; Perforation

  MAUDE report 20245231 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PAST HISTORY, CONSTITUTION, ETC.: UNKNOWN. THE PATIENT HAS AN INFECTION, BUT THE CAUSE IS UNKNOWN. SEVERITY AS CONSIDERED BY THE DOCTOR: HOSPITALIZATION OR EXTENSION OF HOSPITALIZATION PERIOD. RELATED PRODUCTS -LR-EVN-13.0-RL/N197583. -LR-OFA01/N198260. -LR-OTE-N/N192484. DEFECT OCCURRENCE STATUS: DURING REMOVING THE RA LEAD THAT WAS IMPLANTED IN THE RIGHT ANTERIOR CHEST IN 1987, WHILE THE PHYSICIAN GRASPED THE RING ELECTRODE PART OF THE RA LEAD WITH LR-NES001 APPROACHED FROM SUBCLAVIAN VEIN AND ATTEMPTED TO REMOVE THE ADHESIONS OF THE LEAD WITH THE LR-EVN-13.0-RL INSERTED FROM THE LEAD INSERTION SITE (SUBCLAVIAN VEIN) PULLING IT TOWARD THE FEMORAL SIDE, THE TIP OF THE RA LEAD FELL TOWARD THE FEMORAL SIDE AND IT APPEARED THAT THE TIP OF THE LEAD HAD COME OFF. WHEN DR. (B)(6), WHO WAS ACTING AS HIS ASSISTANT, ATTEMPTED TO GRASP IT AGAIN WITH LR-NES001, THE PATIENT'S BLOOD PRESSURE DROPPED. THE PATIENT WAS MONITORED FOR A WHILE, BUT HIS BLOOD PRESSURE DID NOT RETURN TO NORMAL AND CONTINUED TO DROP GRADUALLY, SO THE SURGEON, DR. (B)(6), REQUESTED ASSISTANCE FROM A CARDIOVASCULAR SURGEON. A CARDIOVASCULAR SURGEON PERFORMED HEMOSTASIS THROUGH THORACOTOMY. DR. (B)(6) SAID THAT THERE WERE

  Patient problems: Cardiac Tamponade

  MAUDE report 18663417 ↗
• MalfunctionAug 1, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  THE NEEDLE EYE SNARE (NES) BROKE IN THE PATIENT. CC FORM: THE NES SYSTEM WAS USED ACCORDING TO THE INSTRUCTION OF USE WITH THE SELDINGER TECHNIQUE. AFTER THE DR. INSERTED THE NES SYSTEM VIA THE OUTER SHEATH UP TO THE RIGHT VENTRICLE THEY SAW ON THE X-RAY THAT THERE WAS A SHARP END. THE NES SYSTEM WAS REMOVED A REPLACED BY A NEW SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17434504 ↗
• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS LITERATURE FINDING SPECIFIES A MAJOR ADVERSE EVENT ATTRIBUTED TO THE LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION (LR-NES001) FOR TWO PATIENTS DURING A STUDY BY (B)(6), ET AL. THE TWO PATIENTS DEVELOPED PERICARDIAL TAMPONADE FROM ATRIAL PERFORATION AFTER SUCCESSFUL LEAD REMOVAL. BOTH PERFORATIONS OF THE ATRIAL WALL OCCURRED AFTER EXTRACTING THE LEAD WITH A NEEDLE¿S EYE SNARE AND THE PATIENTS WERE IMMEDIATELY OPERATED ON AND RECOVERED COMPLETELY LATER. THIS REPORT REPRESENTS PATIENT #2.

  Patient problems: Cardiac Tamponade

  MAUDE report 11555352 ↗
• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS LITERATURE FINDING SPECIFIES A MAJOR ADVERSE EVENT ATTRIBUTED TO THE LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION (LR-NES001) FOR TWO PATIENTS DURING A STUDY BY BRACKE, ET AL. THE TWO PATIENTS DEVELOPED PERICARDIAL TAMPONADE FROM ATRIAL PERFORATION AFTER SUCCESSFUL LEAD REMOVAL. BOTH PERFORATIONS OF THE ATRIAL WALL OCCURRED AFTER EXTRACTING THE LEAD WITH A NEEDLE¿S EYE SNARE AND THE PATIENTS WERE IMMEDIATELY OPERATED ON AND RECOVERED COMPLETELY LATER.

  Patient problems: Cardiac Tamponade

  MAUDE report 11554745 ↗
• InjuryFeb 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER REMOVING THE LEAD IN THE RIGHT ATRIUM, DURING A LEAD EXTRACTION PROCEDURE, THE PHYSICIAN STARTED TO DETACH THE LEAD IN THE RIGHT VENTRICLE FROM A SUPERIOR APPROACH. HOWEVER, THE ADHESIONS NEAR THE TIP OF THE LEAD WERE SO STRONG THAT THE GLIDE LIGHT 14FR (LASER SHEATH/PHILIPS), WHICH WAS BEING APPROACHED FROM THE SUBCLAVIAN VEIN, GOT STUCK NEAR THE LEAD TIP AND WOULD NOT MOVE. THE PHYSICIAN TRIED TO REMOVE THE STUCK LEAD BY CHANGING TO AN FEMORAL APPROACH AND PULLING IT FROM BELOW THE VEIN OF THE INGUINAL REGION, USING THE REPORTED LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE (LR-NES001), BUT THEY WERE UNABLE TO THE LEAD. THE PHYSICIAN THEN USED A COOK CURVE FEMORAL INTRODUCER SHEATH SET (LR-CSS16) AND A COOK CURVED FEMORAL SHEATH (LR-CRVFEM001) TOGETHER. THE PHYSICIAN MANAGED TO GRAB THE RIGHT VENTRICLE LEAD USING THE NEEDLE'S EYE FEMORAL SNARE (LR-NES-001) AND PULL IT DOWNWARD. THEY WERE THEN ABLE TO RETRIEVE THE STUCK PHILIPS GLIDE LIGHT 14FR. THE PHYSICIAN CHANGED FROM A PHILIPS GLIDE LIGHT 14FR TO A PHILIPS GLIDE LIGHT 16FR. WITH THE PHILIPS GLIDE LIGHT 16FR, THE PHYSICIAN ATTEMPTED TO DETACH THE ADHESION, BUT THERE WAS A "LONG ADHESION OR TISSUE" ON TH

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 11361057 ↗
• InjuryJul 28, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACTIVE FIXATION RIGHT ATRIAL LEAD THAT HAD BEEN PREVIOUSLY BEEN ATTEMPTED TO BE EXTRACTED, WAS EXTRACTED SUCCESSFULLY WITH COOK FEMORAL KIT. (LEAD EXTRACTION, PREVIOUS ATTEMPT WITH LASER IN (B)(6) 2016 IN (B)(6)). LEFT SIDED RV LEAD WAS ALSO SUCCESSFULLY EXTRACTED WITH COOK FEMORAL KIT. RIGHT SIDED RV LEAD, ATTEMPTED EXTRACTION WITH COOK FEMORAL KIT, PARTIAL EXTRACTION COMPLETED. (DISTAL TIP OF LEAD PLUS 3-4CM OF INNER CORE WIRE LEFT IN SITU IN RV). UPON STOPPING THE PROCEDURE TO FINISH, THE PATIENTS BP (BLOOD PRESSURE) DROPPED. CPR WAS PERFORMED AND THE SURGEON PERFORMED FEMORAL BY-PASS AND THORACOTOMY. TAMPONADE FROM RIGHT ATRIAL APPENDAGE AND OOZING FROM INNOMINATE VEIN. IT SHOULD BE NOTED THAT IT WAS NOT SUGGESTED THAT THIS WAS CAUSED BY ANY COOK PRODUCT, RATHER THAT THE ACTIVE FIX ATRIAL LEAD THAT HAD BEEN CUT PREVIOUSLY WAS THE CAUSE. THE PATIENT ULTIMATELY PASSED AWAY (DIED) (B)(6) FROM ISCHAEMIC BOWEL. ADDITIONAL INFORMATION WAS PROVIDED 28JULY; WHICH STATED: NO PRODUCTS FROM COOK MEDICAL WERE AT FAULT OR FAILED TO FUNCTION CORRECTLY. THE ACTIVE FIXATION RIGHT ATRIAL LEAD HAD BEEN CUT EARLIER THIS YEAR WHEN AN ATTEMPTED LASER EXTRACTION WAS PERFORMED. THE TAMPONADE WAS CAUS

  Patient problems: Cardiac Tamponade

  MAUDE report 5830506 ↗
• InjuryMay 6, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE TO REMOVE THE ELECTRODE, THE HEART GOT PUNCTURED. THE FORMER CAPPED RV LEAD, ORIGINALLY IMPLANTED IN 2005, WAS GRABBED WITH THE COOK LEAD EXTRACTOR. THE LEAD COULD ALSO BE GRABBED WITH A LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND THE OUTER SHEATH WAS PUSHED FORWARD UNTIL THERE WAS A 2 CM DISTANCE TO THE TIP. THE LEAD WAS EXTRACTED SUCCESSFULLY. AFTER A MOMENT, THE PATIENT'S BLOOD PRESSURE DROPPED AND OPEN HEART SURGERY WAS PERFORMED. THE PATIENT HAD TO BE REANIMATED (RESUSCITATED) DURING THE PROCEDURE. A SMALL HOLE IN THE RIGHT VENTRICLE WAS FOUND. THE PATIENT FELT WELL WHEN SHE LEFT THE OR. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID REQUIRE EXTERNAL AND INTERNAL DEFIBRILLATION. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AFTER TO THIS OCCURRENCE.

  Patient problems: Cardiac Perforation; Cardiopulmonary Arrest

  MAUDE report 5637584 ↗