LunderquistRecalls & reported problems across all models

We found 2 models of Lunderquist by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, 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 at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Lunderquist recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 2 of these models · Recall details · FDA record ↗

Most reported Lunderquist problems

Lunderquist models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Lunderquist G27031

  WIRE, GUIDE, CATHETER
  1 recall3 reports
• Lunderquist G27033

  WIRE, GUIDE, CATHETER
  1 recall0 reports

Recent Lunderquist adverse event reports

The 3 most recent reports across all models, 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 NO DIFFICULTY WAS EXPERIENCED WHILE INSERTING THE WIRE GUIDE AND THE WIRE WAS WITHDRAWN THROUGH A DRAINAGE CATHETER.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 ↗

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