Lunderquist G27031Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002270312), received between Mar 17, 2022 and Mar 17, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 16, 2022Open, Classified

   Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

   Z-1845-2022 · Root cause: Under Investigation by firm · FDA record ↗

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.

• MalfunctionMar 17, 2022Unraveled Material; Unraveled Material

  IT WAS REPORTED A LUNDERQUIST-RING TORQUE INTERVENTIONAL WIRE GUIDE UNRAVELED AT THE PROXIMAL PART OF THE WIRE. THE UNRAVELING WAS NOTED AT THE END OF A DRAIN EXCHANGE PROCEDURE. NO DIFFICULTY WAS EXPERIENCED WHILE INSERTING THE WIRE GUIDE AND THE WIRE WAS WITHDRAWN THROUGH A DRAINAGE CATHETER. IT WAS ALSO NOTED THAT THE WIRE GUIDE INSERTION TOOL WAS NOT INSERTED THROUGH THE VALVE ASSEMBLY OR HUB OF THE GUIDING SHEATH BEFORE THE TIP OF THE WIRE GUIDE WAS INSERTED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13801529 ↗
• MalfunctionMar 17, 2022Unraveled Material; Unraveled Material

  IT WAS REPORTED A LUNDERQUIST-RING TORQUE INTERVENTIONAL WIRE GUIDE UNRAVELED AT THE END OF THE WIRE. THE UNRAVELING WAS NOTED AT THE END OF A DRAIN EXCHANGE PROCEDURE. NO DIFFICULTY WAS EXPERIENCED WHILE INSERTING THE WIRE GUIDE AND THE WIRE WAS WITHDRAWN THROUGH A DRAINAGE CATHETER. IT WAS ALSO NOTED THAT THE WIRE GUIDE INSERTION TOOL WAS NOT INSERTED THROUGH THE VALVE ASSEMBLY OR HUB OF THE GUIDING SHEATH BEFORE THE TIP OF THE WIRE GUIDE WAS INSERTED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13801524 ↗
• MalfunctionMar 17, 2022Unraveled Material; Unraveled Material

  IT WAS REPORTED A LUNDERQUIST-RING TORQUE INTERVENTIONAL WIRE GUIDE UNRAVELED DURING PREPARATION FOR A PROCEDURE. THE UNRAVELING OCCURRED PRIOR TO PATIENT CONTACT AND WAS NOTED AT THE PROXIMAL END OF THE WIRE. IT WAS ALSO NOTED THAT THE WIRE GUIDE INSERTION TOOL WAS NOT INSERTED THROUGH THE VALVE ASSEMBLY OR HUB OF THE GUIDING SHEATH BEFORE THE TIP OF THE WIRE GUIDE WAS INSERTED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13801485 ↗