EchoTip ProCore G34282Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002342828), received between Apr 14, 2016 and Dec 20, 2018 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2018Break; Break

  DR (B)(6) PERFORMED AN EBUS. AT THE END OF THE PROCEDURE IT WAS NOTED THAT THE TIP OF THE NEEDLE HAD SHEARED OFF. THE PROCEDURE WAS NOT A DIFFICULT ONE. A CT WAS PERFORMED AND THE TIP WAS IN THE NODE. A BRONCHOSCOPE WAS PERFORMED AND THE TIP WAS RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8184440 ↗
• MalfunctionOct 3, 2018Break; Break

  AS REPORTED TO CUSTOMER RELATIONS: "WHEN PLACED DOWN THE SCOPE, NEEDLE WOULD NOT COME OUT OF THE SHEATH. REMOVED NEEDLE FROM SCOPE AND USED ANOTHER DEVICE SUCCESSFULLY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7929964 ↗
• MalfunctionFeb 27, 2018Bent; Kinked; Bent; Kinked

  AFTER VOCAL CORDS AND SUBSEGMENTAL BRONCHUS WAS OBSERVED BY ENDOSCOPY, EBUS-TBNA (ENDOSCOPIC ULTRASOUND GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION) WAS PERFORMED. THE USER INSERTED AND POSITIONED OLYMPUS' BF-UC260FW AT 4R (RIGHT LOWER PARATRACHEAL NODES). THEN HE INSERTED ECHO-HD-25-EBUS-O-C WITH THE STYLET INSERTED FULLY AND PUNCTURED THE TARGET SITE. IT WAS CONFIRMED THAT THE SOME CELLS WAS COLLECTED SUCCESSFULLY AT FIRST PUNCTURE. THEN, THE USER ATTEMPTED SECOND PUNCTURE, HOWEVER THE NEEDLE DID NOT STICK IN BECAUSE THE PUNCTURE QUALITY OF THE NEEDLE WAS NOT GOOD, SO HE REMOVED THE NEEDLE FROM THE ENDOSCOPE AND IT WAS CONFIRMED THAT THE NEEDLE BENT AT 2~3CM FROM THE TIP. SOME CELLS WERE COLLECTED BY THE FIRST PUNCTURE, SO HE COMPLETED THE PROCEDURE WITHOUT USING OTHER DEVICES TO COLLECT MORE CELLS. [NOTE]: THE FIRST PUNCTURE WAS SMOOTH. AT THE SECOND PUNCTURE, THE NEEDLE WAS INSERTED INTO THE SCOPE SMOOTHLY, BUT IT ID NOT STICK WELL. I CANNOT DENY THE POSSIBILITY THAT THE NEEDLE PENETRATED CARTILAGES, OR ADVANCED THE SURFACE OF CARTILAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7298997 ↗
• MalfunctionFeb 27, 2018Bent; Kinked; Bent; Kinked

  AFTER VOCAL CORDS AND SUBSEGMENTAL BRONCHUS WAS OBSERVED BY ENDOSCOPY, EBUS-TBNA (ENDOSCOPIC ULTRASOUND GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION) WAS PERFORMED. THE USER INSERTED AND POSITIONED OLYMPUS' BF-UC260FW AT 4R (RIGHT LOWER PARATRACHEAL NODES). THEN HE INSERTED ECHO-HD-25-EBUS-O-C WITH THE STYLET INSERTED FULLY AND PUNCTURED THE TARGET SITE. AT THE FIRST BIOPSY, THE NEEDLE DID NOT STICK IN BECAUSE THE PUNCTURE QUALITY OF THE NEEDLE WAS NOT GOOD, SO THE USER REMOVED THE NEEDLE FROM THE ENDOSCOPE AND IT WAS CONFIRMED THAT THE NEEDLE BENT AT 2~3 CM FROM THE TIP. ANOTHER DEVICE (ECHO-HD-22-EBUS-O-C) WAS USED INSTEAD TO COMPLETE THE PROCEDURE. [NOTE] THE NEEDLE WAS ADVANCED INTO THE SCOPE SMOOTHLY, BUT IT DID NOT STICK WELL. I CANNOT DENY THE POSSIBILITY THAT THE NEEDLE PENETRATED CARTILAGES, OR ADVANCED THE SURFACE OF CARTILAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7298882 ↗
• MalfunctionNov 15, 2017Break; Break

  THIS FOLLOW UP MDR IS BEING SUBMITTED AS THE DEVICE WAS RETURNED AND EVALUATED. NO BLEEDING DURING THE PROCEDURE. 1ST NODE RIGHT HILAR (SIZE 8MM) 2 PASSES 10 FANS FOR EACH PASS. 2ND NODE : 4L LEFT LATERO TRACHEAL. 1ST PASS /10 FANS = NO PROBLEM. DURING THE SECOND PASS, DR (B)(6) FELT SOMETHING NOT NORMAL. VIDEO SHOWED NEEDLE WEAKNESS. PROCEDURE HAS BEEN IMMEDIATELY STOPPED. THE PHYSICIAN DECIDED TO REMOVE ALL AT THE SAME TIME (NEEDLE+ECHOENDO) TO AVOID ECHOENDO DAMAGE AND OTHER INCIDENT RISKS. NO PART OF THE NEEDLE REMAINED IN PATIENT BODY. AT THE END OF THE REMOVAL, WHEN ECHOENDO+NEEDLE WERE THROUGH I GEL, NEEDLE HAS BROKEN, BROKEN PART OF IT WAS BLOCKED IN I GEL LARYNGEAL MASK. REMOVAL OF THE I GEL, THEN PART OF THE NEEDLE BROKEN RETRIEVAL. A NEW EBUS NEEDLE WAS NEEDED TO CONTINUE THE PROCEDURE. NO PROBLEM WITH ECHO ENDO. NO PROBLEM WITH NEEDLE INSERTION THROUGH ECHOENDO CHANNEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7033355 ↗
• InjuryMay 25, 2017Break; Break

  DOCTOR WAS DOING A FINE NEEDLE BIOPSY AND UNDER ULTRASOUND OF THE LUNG, STATIONS 10 OR 11. THE DOCTOR NOTICED SOME CALCIFICATIONS BUT NOT AS SEVERE AS IN OTHER PATIENTS. UPON DOING PASSES, WHEN HE PULLED THE NEEDLE BACK, HE FELT SIGNIFICANT RESISTANCE. HE WENT BACK TO ENDOSCOPICALLY EXAM THE BRONCHIAL AIRWAY TO SEE IF A FOREIGN BODY WAS LEFT BEHIND BY THE NEEDLE. HE DID NOT SEE ANYTHING AT THE TIME. THE NEXT MORNING, THE PATIENT REPORTEDLY COUGHED UP A FOREIGN BODY. THE PICTURE REPRESENTS THE DISTAL END OF THE 25 GAUGE ECHO TIP PROCORE EBUS NEEDLE THAT THE PATIENT COUGHED UP. NO OTHER INTERVENTIONS WERE NEEDED PATIENT IS DOING OK. PATIENT IS (B)(6) FEMALE NO DIAGNOSIS WAS REACHED ON THE EXAM. PER MEDWATCH PROVIDED BY USER FACILITY PROVIDED 03MAY2017: "DURING A BRONCHOSCOPY WITH GENERAL ANESTHESIA--LMA, THE EBUS WAS USED TO OBTAIN A FEW SPECIMENS. THEN WHEN TRYING TO ACQUIRE ADDITIONAL SPECIMENS, THE PHYSICIAN NOTICED THE NEEDLE ADJUSTER WOULD NOT EXPEL THE NEEDLE. THAT PARTICULAR EBUS WAS SET ASIDE AND A NEW ONE WAS USED TO COMPLETE THE PROCEDURE. NO COMPLICATIONS WERE NOTED UNTIL 2 DAYS LATER, WHEN THE PATIENT FELT 'SOMETHING STUCK IN HER THROAT' AFTER EATING A MEAL AND SHE USED H

  Patient problems: Foreign Body In Patient

  MAUDE report 6590374 ↗
• MalfunctionApr 14, 2016Break; Break

  DURING THE PROCEDURE, PART OF THE NEEDLE BROKE WHILE IN USE, THIS OCCURRED IN THE LYMPH NODE WHILE REMOVING THE STYLET. THE BROKEN DISTAL TIP WAS LEFT IN THE PATIENT AND A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5575905 ↗