Needle's Eye G26515Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002265158), received between Jun 24, 2016 and May 28, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE NEEDLES EYE PORTION OF THE NEEDLE'S EYE SNARE (LR-NES002) BROKE OFF INSIDE THE PATIENT DURING A TWISTING MANEUVER WITHOUT PULLING THE LEADS OR PUSHING THE SHEATH. THE BROKEN PORTION WAS RETRIEVED FROM INSIDE THE PATIENT USING ANOTHER NEEDLE'S EYE SNARE OF THE SAME MODEL. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION.CONSTRAINT ON THE NES.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10099249 ↗
• InjuryOct 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEAD EXTRACTION WAS PERFORMED WITH LR-EVN-11.0-RL, GLIDELIGHT LASER SHEATH / PHILIPS AND A LEAD LOCKING DEVICE(LLD EZ /PHILIPS). LR-EVN-11.0-RL ADVANCED OVER RA LEAD WITH GLIDELIGHT LASER SHEATH BUT LR-EVN-11.0-RL STOPPED ADVANCING AT THE SVC, SO THE USER CHANGED THE APPROACH TO FEMORAL APPROACH. LR-NES002/LOT N160621 WAS USED AND THE USER CAPUTURED RA LEAD AND RV LEAD TOGETHER AND EXTRACTED THE LEADS BUT THE PATIENT BLOOD PRESSURE DROPPED. PERICARDIAL DRAINAGE, BLOOD TRANSFUSION WERE PERFORMED AND THEN THORACOTOMY WAS PERFORMED WITH PCPS. AFTER STOPPED BLEEDING, RV LEAD WAS EXTRACTED FIRST AND THEN RA LEAD WAS EXTRACTED WIRH LR-NES001. CURRENTLY THE PATIENT IS UNDER TREATMENT IN ICU.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 9227125 ↗
• InjuryJun 24, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE SUCCESSFUL EXTRACTION OF RV LEAD WITH THE LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AFTER 10 MIN AT ICU THEY SAW A CARDIAC TAMPONADE. PUNCTION OF PLEURA AND DRAIN UP TO 2 L BLOOD DURING 3 HOURS. INTUBATION OF PATIENT AGAIN AND MOVED TO HYPRID KATH LAB/OR. THE HEART SURGEON WAS IN STANDBY FOR THORACOTOMY, BUT AFTER 3 HOURS A FEW THROMBIN WAS SEEN AND THE BLEEDING STOPPED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Blood Loss; Cardiac Tamponade

  MAUDE report 5748280 ↗