EchoTip ProCore G34279Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00827002342798), received between Aug 2, 2016 and Mar 19, 2026 — classified as 26 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Break” (35 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 25 most recent of 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026

  ENDOBRONCHIAL ULTRASOUND NEEDLE USED FOR NEEDLE BIOPSY DURING BRONCH PROCEDURE; NEEDLE BROKE OFF IN THE PATIENTS BRONCHIAL. DR. (B)(6) TO USE BIOPSY FORCEPS TO RETRIEVE BROKEN NEEDLE PIECE OUT OF BRONCHIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638360 ↗
• MalfunctionNov 6, 2025Material Twisted/Bent; Material Twisted/Bent

  AFTER A SECOND PUNCTURE, THE NEEDLE BECAME TWISTED IN THE LYMPH NODE, MAKING IT IMPOSSIBLE TO WITHDRAW IT COMPLETELY INTO ITS SHEATH. POSSIBLE DAMAGE TO THE INNER SHEATH OF THE BRONCHIAL ECHOENDOSCOPE. NEEDLE CHANGED IN ORDER TO CONTINUE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485435 ↗
• InjurySep 25, 2025Break; Fracture; Break; Fracture

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 18-NOV-2025.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23151815 ↗
• MalfunctionJan 8, 2020Break; Material Perforation; Break; Material Perforation

  NEEDLE WENT TROUGH THE DISTAL PART SHEATH. AS PER CC FORM: WHEN THE NEEDLE WAS PUSHED FORWARD, THE CATHETER WAS PIERCED. THAT WAS NOT ANGLED AT THE TIME. THE ENDOSCOPE AND THE PATIENT REMAINED UNHARMED. THE COMPLAINT DEVICE WAS RETURNED AND EVALUATED ON (B)(6) 2020 AND THE DISTAL END OF THE NEEDLE WAS CONFIRMED TO BE BROKEN. NO PART OF THE NEEDLE REMAINS IN THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO CONFIRM IF THE NEEDLE BROKE INSIDE / OUTSIDE THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9563196 ↗
• MalfunctionNov 26, 2019Off-Label Use; Off-Label Use

  ACCORDING TO DR (B)(6), AFTER THE THIRD PASS, THE NEEDLE COULD NOT PENETRATE THE LYMPH NODE; THERE WAS RESISTANCE AND THE NEEDLE KEPT "BOUNCING" INSTEAD OF GOING THROUGH THE LESION. THE CASE WAS THEN COMPLETED WITH A NEW ECHO-HD-22-EBUS-P-C ADDITIONAL INFORMATION CONFIRMED 'USER ERROR'- AS THE STYLET WAS PARTIALLY REMOVED WHEN ADVANCING TO TARGET SITE AND THE OVERALL RISK IF THIS FAILURE HAS BEEN ASSESSED AS MODERATE. NO ADVERSE EFFECTS TO THE PATIENT WAS REPORTED AS OCCURRING. A MODERATE RISK RATING INDICATES POTENTIAL FOR INJURY TO OCCUR IF THE EVENT WAS TO RECUR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9376151 ↗
• InjuryOct 29, 2019Break; Break

  PER DR. (B)(6) VIA EMAIL: THE NEEDLE BENT AT THE PATIENT END AND BROKE OFF WHEN THE SCOPE WAS WITHDRAWN. THERE WAS NO ISSUE ON VISUAL INSPECTION OF THE NEEDLE BEFOREHAND, AFTER THE PROCEDURE, THE END OF THE NEEDLE WAS NOT PRESENT. THE NEEDLE REMNANT ADVANCED THROUGH THE SHEATH WITHOUT ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 9248678 ↗
• InjuryOct 25, 2019Break; Break

  PER DR. (B)(6) VIA EMAIL: THE NEEDLE BENT AT THE PATIENT END AND BROKE OFF WHEN THE SCOPE WAS WITHDRAWN. THERE WAS NO ISSUE ON VISUAL INSPECTION OF THE NEEDLE BEFOREHAND, AFTER THE PROCEDURE, THE END OF THE NEEDLE WAS NOT PRESENT. THE NEEDLE REMNANT ADVANCED THROUGH THE SHEATH WITHOUT ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 9240477 ↗
• InjuryOct 2, 2019Break; Break

  NEEDLE GOT BROKEN WHILE TAKING SAMPLE FROM THE SUBCRANIAL REGION APPROXIMATELY 1.5 CM FROM THE TIP. THE TIP GOT DETACHED AND RETRIEVAL THROUGH FLEXIBLE SCOPE USING FORCEPS.

  Patient problems: Foreign Body In Patient

  MAUDE report 9144140 ↗
• InjurySep 26, 2019Break; Break

  THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE RETURN AND EVALUATION OF THE DEVICE INVOLVED IN THIS EVENT. INITIAL REPORT DETAILS: THE NEEDLE BROKE ON THE TRACHEA DURING PUNCTURE, THE TIP HAS BEEN RETRIEVED WITH A FORCEPS.

  Patient problems: Foreign Body In Patient

  MAUDE report 9121907 ↗
• MalfunctionAug 22, 2019Difficult to Advance; Difficult to Advance

  NEEDLE IS NOT SMOOTH DURING PROCEDURE(DIFFICULT TO PUSH NEEDLE OUT FROM SHEALTH), BUT TESTED OUTSIDE SCOPE WAS FINE (WHEN IT IS IN STRAIGHT POSITION). VERY HARD FOR DOCTOR TO USE THE NEEDLE TO DO BIOPSY PROCESS WHILE DR (B)(6) TRY ANOTHER SET OF NEEDLE IS FINE. ADDITIONAL INFORMATION PROVIDED ON 25-JUL-19 CONFIRMED THAT THE STYLET WAS REMOVED ABOUT 2-3CM WHEN ADVANCING TO TARGET SITE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8921159 ↗
• MalfunctionAug 21, 2019Retraction Problem; Retraction Problem

  DESOLIDARISATION OF THE SHEATH DURING ITS FIRST USE (MOBILE SHEATH), THE NEEDLE COULD NOT GET OUT ANYMORE. CONSEQUENCES: BIOPSY NEEDLE NOT USABLE ANYMORE. ECHO ENDO. DURING THE LABORATORY EVALUATION OF THE RETURNED DEVICE ON (B)(6) 2019 IT WAS NOTED THAT THE NEEDLE WAS UNABLE TO ADVANCE OR RETRACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8915357 ↗
• InjuryJun 20, 2019Break; Break

  THE TIP BROKE OFF DURING PROCEDURE ON PATIENT. WAS RECOVERED. AS PER COMPLAINT FORM "AFTER TWO PUNCTION WITH EASY ACCESS IN LUNG, DURING THE 3RD PUNCTION, THE NEEDLE BROKE".

  Patient problems: Foreign Body In Patient

  MAUDE report 8715478 ↗
• MalfunctionJun 13, 2019Difficult to Advance; Difficult to Advance

  THE PROBLEM WE BELIEVE IS THAT THE SHEATH HAS A KINK/BEND ON IT SO WHEN THE NEEDLE IS BEING PUSHED OUT IT IS CATCHING ON THE SIDE OF THE SHEATH. AS PER COMPLAINT FORM: "TWO OUT OF FIVE NEEDLES FAILED. IT WAS THE SAME DOCTOR THAT USED BOTH NEEDLES. NURSES EXPLAINED THAT DOCTOR ELEANOR USED FORCE AND CAUGHT CARTILAGE ON THE NEEDLE." REFERENCE ALSO 3001845648-2019-00257.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8695655 ↗
• MalfunctionJun 12, 2019Difficult to Advance; Difficult to Advance

  THE PROBLEM WE BELIEVE IS THAT THE SHEATH HAS A KINK/BEND ON IT SO WHEN THE NEEDLE IS BEING PUSHED OUT IT IS CATCHING ON THE SIDE OF THE SHEATH. AS PER COMPLAINT FORM: "TWO OUT OF FIVE NEEDLES FAILED. IT WAS THE SAME DOCTOR THAT USED BOTH NEEDLES. NURSES EXPLAINED THAT DOCTOR ELEANOR USED FORCE AND CAUGHT CARTILAGE ON THE NEEDLE." REFERENCE ALSO 3001845648-2019-00256.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8691596 ↗
• MalfunctionApr 2, 2019Failure to Advance; Failure to Advance

  AS PER ADDITIONAL INFORMATION RECEIVED ON 06-MAR-2019: THE NEEDLE WAS BENT AND COULDN'T BE REMOVED (REFERENCE REPORT# 3001845648-2019-00134), 2ND NEEDLE WAS THEN THE 25 WHICH KINKED DIRECTLY ON FIRST TRIAL. (REFERENCE REPORT# 3001845648-2019-00126), 3RD NEEDLE COULDN¿T MOVED OUT OF THE CATHETER AND HOOKED IN THE CATHETER (THIS COMPLAINT). COMPLAINT DETAILS AS PER ORIGINAL FILE (REPORT#3001845648-2019-00134). AS PER COMPLAINT FORM: "DR. (B)(6) TOLD ME THAT HE REMEMBERED THE NEEDLE BENT A STICK IN THE CATHETER, SO HE COULDN'T MOVE THE NEEDLE ANYMORE. THIS HAPPENED ON STAGE N4. CHIEF DR. (B)(6). HE IS VERY WELL KNOWN AND EXPERIENCED IN THE FIELD OF PNEUMOLOGISTS AND LEADS A SPECIAL HOSPITAL FOR LUNG DISEASES. HE WORKED ALREADY WITH OUR NEEDLE FOR MORE THEN 2,5 YEAR IN THE MEANTIME AND HAD MIN. 500 PUNCTURES WITH OUR NEEDLES SINCE THEN. WHEN HE LIKE TO HAVE MORE FLEXIBILITY HE ALSO USES THE 25 NEEDLE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8474336 ↗
• MalfunctionApr 2, 2019Material Twisted/Bent; Material Twisted/Bent

  THE NEEDLE WAS BENT AND COULDN'T BE REMOVED. AS PER COMPLAINT FORM: "DR. (B)(6) TOLD ME THAT HE REMEMBERED THE NEEDLE BENT A STICK IN THE CATHETER, SO HE COULDN'T MOVE THE NEEDLE ANYMORE. THIS HAPPENED ON STAGE N4. CHIEF DR. (B)(6). HE IS VERY WELL KNOWN AND EXPERIENCED IN THE FIELD OF PNEUMOLOGISTS AND LEADS A SPECIAL HOSPITAL FOR LUNG DISEASES. HE WORKED ALREADY WITH OUR NEEDLE FOR MORE THEN 2,5 YEAR IN THE MEANTIME AND HAD MIN. 500 PUNCTURES WITH OUR NEEDLES SINCE THEN. WHEN HE LIKE TO HAVE MORE FLEXIBILITY HE ALSO USES THE 25 NEEDLE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8472822 ↗
• MalfunctionMar 28, 2019Retraction Problem; Retraction Problem

  EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿'NON RETRACTION OF NEEDLE." DURING PROCEDURE NEEDLE TIP KINKED WITHIN THE BRONCHOSCOPE. AS PER COMPLAINT FORM: "DR. (B)(6), PNEUMOLOGIST. HE IS THERE SINCE 3 MONTH. WITH THE FIRST 22 NEEDLE HE PUNCTURED 3 X N11, 1 X N4 AND 1 X N7. DURING THE LAST 5TH PUNCTURE THE NEEDLE BENT. THE NEEDLE COULDN'T BE PLACED IN THE CATHETER SO WE DECIDED TO BRING OUT BOTH - NEEDLE AND SCOPE TOGETHER. THEN WE CALLED THE CHIEF DOCTOR AND HE CALLED THE TECHNICIAN. HE BENT THE NEEDLE BACK SO WE COULD PLACE THE NEEDLE BACK INTO THE CATHETER AND BRING OUT THE NEEDLE FROM SCOPE WITHOUT ANY DAMAGE. THEN HE TAKE A NEW 22 NEEDLE AND PUNCTURE THE NEXT 1 X N10. ON THE SECOND TRIAL THE NEEDLE WAS AGAIN HARDLY TO MOVE WITHOUT ANY FORCE SO THAT HE DECIDED TO BREAK UP THIS PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8459643 ↗
• MalfunctionMar 15, 2019Break; Break

  AS REPORTED TO CUSTOMER RELATIONS "WHEN THEY TRIED TO EXTEND THE NEEDLE OUT OF THE SHEATH, THE NEEDLE APPEARED TO BE BROKEN AT DISTAL END AND WOULD NOT ADVANCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8423876 ↗
• MalfunctionMar 13, 2019Material Twisted/Bent; Activation Failure

  IT IS REPORTED BY THE PULMONOLOGIST PERFORMING THE BIOPSY AND BY THE BRONCH LAB STAFF THAT THEY HAVE HAD SEVERAL INCIDENTS WITH THE ECHOTIP PROCORE HD EBUS FOR PENTAX SCOPES. THE MOST RECENT COMPLAINT REPORTED IS THAT DURING PROCEDURE, THE PULMONOLOGIST WAS UNABLE TO DEPLOY THE NEEDLE FOR BIOPSY. PRIOR TO PROCEDURE, THE DEPLOYMENT WAS CHECKED TO ENSURE THAT IT WAS FUNCTIONING PROPERLY, HOWEVER, IT MALFUNCTIONED DURING PROCEDURE. THIS IS THE MAJORITY OF THE COMPLAINTS RECEIVED. ADDITIONALLY, THERE ARE MULTIPLE COMPLAINTS OF THE SHEATH NOT DEPLOYING STRAIGHT, IT SLIDES OFF AND BENDS THE NEEDLE ULTIMATELY LEADING TO THE INABILITY TO OBTAIN BIOPSY AND HAVING TO USE ADDITIONAL NEEDLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8420702 ↗
• MalfunctionFeb 15, 2019Break; Break

  COOK (B)(4) WERE INFORMED OF AN INCIDENT WITH THE ECHOTIP PROCORE ENDOBRONCHIAL HD ULTRASOUND BIOPSY NEEDLE BY (B)(6) REFERENCE# (B)(4) AS FOLLOWS: "WE HAVE BEEN INFORMED OF AN INCIDENT WITH THE ECHOTIP PROCORE ENDOBRONCHIAL HD ULTRASOUND BIOPSY NEEDLE (MODEL ECHO-HD-22-EBUS-P-C / G34279 ¿ LOT C1527151). INCIDENT DESCRIPTION: BROKEN NEEDLE. THE LOT NUMBER HAS BEEN CONFIRMED BUT THE HOSPITAL / COMPLAINT FACILITY BE CONFIRMED. INCIDENT DATE NOT CONFIRMED YET." WE SUSPECT THIS REPORT MAY BE A DUPLICATE REPORT OF COOK REFERENCE NUMBER (B)(4) / MDR REPORT# 3001845648-2018-00615. WE ARE AWAITING CONFIRMATION FROM (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8342358 ↗
• MalfunctionFeb 15, 2019Break; Break

  COOK (B)(4) WERE INFORMED OF AN INCIDENT WITH THE ECHOTIP PROCORE ENDOBRONCHIAL HD ULTRASOUND BIOPSY NEEDLE BY (B)(6) REFERENCE# (B)(4) AS FOLLOWS: "WE HAVE BEEN INFORMED OF AN INCIDENT WITH THE ECHOTIP PROCORE ENDOBRONCHIAL HD ULTRASOUND BIOPSY NEEDLE (MODEL ECHO-HD-22-EBUS-P-C / G34279 ¿ LOT C1527151). INCIDENT DESCRIPTION: BROKEN NEEDLE. THE LOT NUMBER HAS BEEN CONFIRMED BUT THE HOSPITAL / COMPLAINT FACILITY BE CONFIRMED. INCIDENT DATE NOT CONFIRMED YET." WE SUSPECT THIS REPORT MAY BE A DUPLICATE REPORT OF COOK REFERENCE NUMBER (B)(4) / MDR REPORT# 3001845648-2018-00615. WE ARE AWAITING CONFIRMATION FROM (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8342335 ↗
• MalfunctionJan 2, 2019Break; Break

  THE NEEDLE BROKE DURING THE GANGLIONIC PUNCTION. THE NEEDLE HAS BEEN KINK DURING THE PUNCTION. IMPOSSIBLE TO REPLACE THE NEEDLE IN THE SHEATH. THE NEEDLE HAS BEEN RETRIEVED OUTSIDE THE WORKING CHANNEL TOGETHER WITH THE SCOPE. HE MET PHYSICIAN DR (B)(6) WHO PERFORMED THE PROCEDURE , HE CONFIRM A HOLE APPEAR UP THE TIP OF THE NEEDLE, STYLET WAS REPLACE IN THE NEEDLE AND WHEN STYLET WAS IN IN PLACE NEAR THE NEEDLE TIP, NEEDLE BREAK DOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8207687 ↗
• InjuryDec 13, 2018Break; Break

  THIS REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT BASED ON THE EVALUATION OF THE DEVICE INVOLVED AND RECEIPT OF INFORMATION "CONFIRMING" THAT NO SECTION OF THE DEVICE DETACHED INSIDE THE PATIENT¿S BODY. INITIAL REPORT DETAILS: AS REPORTED TO CUSTOMER RELATIONS "THE DEVICE WAS PLACED DOWN THE SCOPE AND THE NEEDLE WOULD NOT EXIT THE SHEATH. THE DEVICE WAS REMOVED FROM THE SCOPE AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CARE WAS IMPACTED." UPDATE 16NOV2018 - PER PHYSICIAN - NOT SURE IF WHAT WE SAW WAS A BROKEN PIECE. COULD JUST BE A CLOT. I LOOKED AFTER WE SAW DURING BRONCHOSCOPY AND COULDN¿T FIND ANYTHING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8159194 ↗
• InjuryDec 12, 2018Break; Break

  AS PER MEDWATCH REPORT: "AFTER ENDO-BRONCHOSCOPY WITH ULTRASOUND WAS PASSED ON IT'S 7TH PASS IT WAS NOTED THAT THE NEEDLE LOOKED DIFFERENT AND THE TIP WAS MISSING. THE ULTRASOUND SCOPE WAS CHANGED TO A REGULAR SCOPE AND AN ENDOBRONCHIAL SURVEY WAS COMPLETED SHOWING THE BROKEN OFF TIP OF THE NEEDLE WAS IN THE SUBMUCOSAL AREA AT THE SITE OF THE ULTRASOUND GUIDED NEEDLE STICK. THE ENDOBRONCHIAL GRABBER WAS UTILISED IN ATTEMPTING TO GRASP THE NEEDLE TIP HOWEVER THE NEEDLE TIP HAD MOVED AND WAS UNDETECTABLE AND IRRETRIEVABLE".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8155775 ↗
• MalfunctionDec 5, 2018Material Deformation; Material Deformation

  WHILE PERFORMING NEEDLE RETRACTION, A NEEDLE DEFECT WAS NOTED, THE STUDY WAS FINISHED BIOPSY WAS DONE WITH NEEDLE OF OUR COMPETITOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8133626 ↗