EchoTip ProCore G34280Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002342804), received between Mar 15, 2016 and Aug 15, 2019 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Bent” (3 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.

• MalfunctionAug 15, 2019Break; Break

  THE TIP OF THE NEEDLE FROM THE CORE TRAP TO THE TIP BROKE BUT DID NOT DETACH IN THE PATIENT. PRIOR TO THE NEEDLE BREAKING, THERE WAS DIFFICULTY IN ADVANCING. IT IS UNKNOWN IF THIS WAS DUE TO THE TARGET SITE, OR DUE TO THE DEVICE ITSELF. THIS HAPPENED DURING A SAMPLE PASS. ONCE THE DEVICE WAS REMOVED FROM THE PATIENT, THE TIP DID COMPLETELY BREAK OFF IN THE STERILE FIELD; THE TIP OF THE NEEDLE WAS MISPLACED BUT CONFIRMED THAT NO PORTION OF THE DEVICE IS INSIDE THE SCOPE OR PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8897098 ↗
• MalfunctionMar 28, 2019Retraction Problem; Retraction Problem

  THE NEEDLE WAS BENT AND COULDN'T BE REMOVED. "AS PER COMPLAINT FORM": DR. SEESE TOLD ME THAT HE REMEMBERED THE 25 NEEDLE BENT AN STICK IN THE CATHETER, SO HE COULDN'T MOVE THE NEEDLE ANYMORE. THIS HAPPENED ON STAGE N4. CHIEF DR. SEESE. HE IS VERY WELL KNOWN AND EXPERIENCED IN THE FIELD OF PNEUMOLOGISTS AND LEADS A SPECIAL HOSPITAL FOR LUNGDESESES. 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. IN THE MEANTIME THE DEPARTMENT HAS ALREADY ORDERED AND RECEIVED A NEW DELIVERY OF 10 NEEDLES WITH LOT C1578253. BUT THE CHIEF DR. SEESE ALREADY TOLD ME, THAT HE WAS REALLY HAPPY WITH THIS NEEDLE IN THE BEGINNING IN 2015 AND OBSERVED THAT HE HAD MORE PROBLEMS WITH THE NEEDLES SINCE THE LAST 3 MONTH. FDA MDR REPORTING REQUIRED - EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿'NON RETRACTION OF NEEDLE"¿. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8458969 ↗
• MalfunctionDec 20, 2017Bent; Kinked; Bent; Kinked

  THIS COMPLAINT IS ASSOCIATED WITH 3001845648-2017-00597 WITH THE SAME PROCEDURE AND SAME PATIENT, AFTER THE FIRST DEVICE WAS DETECTED WITH TIP BENT , OPERATOR USE THE DEVICE IN THIS PR TO CONTINUE THE PROCEDURE WITH TIP BENT AGAIN. WITH ANOTHER NEW SAME DEVICE TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7133821 ↗
• MalfunctionDec 20, 2017Bent; Kinked; Bent; Kinked

  NEEDLE REACHED ENDOBRONCHIAL(4R) AND COMPLETED FIRST PUNCTURE THEN WITHDRAW THE DEVICE OUT OF PATIENT WHEN THE TIP BENT WAS DETECTED. REPLACE A NEW SAME DEVICE TO CONTINUE THE PROCEDURE WITH TIP BENT AGAIN. WITH ANOTHER NEW SAME DEVICE TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7133671 ↗
• InjuryNov 1, 2016Break; Break

  A FOLLOW-UP MDR IS BEING SUBMITTED TO INCLUDE THE DEVICE EVALUATION DETAILS. THE TIP OF THE NEEDLE AT THE CORE TRAP BROKE OFF INSIDE OF THE PATIENT WHICH WAS RETRIEVED WITH FORCEPS. THE PHYSICIAN THEN USED ANOTHER ECHO-HD-25-EBUS-P-C DEVICE OF THE SAME LOT# AND THIS TIP BENT BUT DID NOT BREAK. THE PHYSICIAN THEN SWITCHED TO AN ECHO-HD-22-EBUS-P-C, LOT# C1256322, AND THE TIP OF THIS NEEDLE AT THE CORE TRAP BROKE OFF INSIDE OF THE PATIENT AND WAS RETRIEVED WITH FORCEPS. A FOURTH NEEDLE, ECHO-HD-22-EBUS-P-C, LOT# C1254294, WAS OPENED AND THE TIP OF THIS DEVICE BENT BUT DID NOT BREAK. THE PHYSICIAN THEN CALLED THE DISTRICT MANAGER AND IT WAS SUGGESTED USE ANOTHER TYPE OF NEEDLE THEREFORE THE PHYSICIAN COMPLETED THE PROCEDURE WITH AN FNA NEEDLE. THE PHYSICIAN STATED THAT IT TOOK APPROXIMATELY ONE HOUR LONGER FOR THE PROCEDURE DUE TO THESE DIFFICULTIES. AS FOUR DEVICES WERE INVOLVED IN THIS EVENT, A SEPARATE REPORT HAS BEING SUBMITTED FOR EACH DEVICE. THIS REPORT REFERENCES THE FIRST DEVICE USED - NEEDLE BREAKAGE. REFERENCE ALSO REPORTS# 3001845648-2016-00306, 3001845648-2016-00307 & 3001845648-2016-00308.

  Patient problems: Foreign Body In Patient

  MAUDE report 6068890 ↗
• MalfunctionNov 1, 2016Bent; Bent

  THE TIP OF THE NEEDLE AT THE CORE TRAP BROKE OFF INSIDE OF THE PATIENT WHICH WAS RETRIEVED WITH FORCEPS. THE PHYSICIAN THEN USED ANOTHER ECHO-HD-25-EBUS-P-C DEVICE OF THE SAME LOT# AND THIS TIP BENT BUT DID NOT BREAK. THE PHYSICIAN THEN SWITCHED TO AN ECHO-HD-22-EBUS-P-C, LOT# C1256322, AND THE TIP OF THIS NEEDLE AT THE CORE TRAP BROKE OFF INSIDE OF THE PATIENT AND WAS RETRIEVED WITH FORCEPS. A FOURTH NEEDLE, ECHO-HD-22-EBUS-P-C LOT# C1254294, WAS OPENED AND THE TIP OF THIS DEVICE BENT BUT DID NOT BREAK. THE PHYSICIAN THEN CALLED THE DISTRICT MANAGER AND IT WAS SUGGESTED USE ANOTHER TYPE OF NEEDLE THEREFORE THE PHYSICIAN COMPLETED THE PROCEDURE WITH AN FNA NEEDLE. THE PHYSICIAN STATED THAT IT TOOK APPROXIMATELY ONE HOUR LONGER FOR THE PROCEDURE DUE TO THESE DIFFICULTIES. AS FOUR DEVICES WERE INVOLVED IN THIS EVENT, A SEPARATE REPORT HAS BEING SUBMITTED FOR EACH DEVICE. THIS REPORT REFERENCES THE SECOND DEVICE USED - TIP BENT. REFERENCE ALSO REPORTS# 3001845648-2016-00305, 3001845648-2016-00307 AND 3001845648-2016-00308.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6068889 ↗
• MalfunctionMar 15, 2016Retraction Problem; Mechanical Jam; Retraction Problem; Mechanical Jam

  DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS) PROCEDURE ON A PATIENT OF UNKNOWN AGE AND GENDER, IT WAS NOTED THAT WHEN THE SPRING THAT PUSHES THE NEEDLE IN AND OUT WAS NOT WORKING PROPERLY. IT SEEMED AS IF THE SPRING HAD SPRUNG. REMOVED THE DEVICE AND USED ANOTHER OF THE SAME TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5499949 ↗