QuickCat Extraction Catheter 60090-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813132020989), received between Oct 1, 2018 and Feb 5, 2021 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Incomplete or Missing Packaging” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2021Incomplete or Missing Packaging; Incomplete or Missing Packaging

  THE MANUFACTURER RECEIVED A COMPLAINT FROM (B)(6) THAT DURING USE IN A PROCEDURE (PATIENT DETAILS AND DETAILS SURROUNDING THE PROCEDURE HAVE NOT BEEN OBTAINED, BUT MULTIPLE REQUESTS HAVE BEEN MADE), A SPECTRANETICS QUICKCAT EXTRACTION KIT WAS NOTED TO NOT CONTAIN, WITHIN THE PACKAGED DEVICE, THE NECESSARY "STOP OR START" FOR THE SYRINGE STEM TO MAINTAIN NEGATIVE PRESSURE OF THE ASPIRATOR. WHEN AGAIN ASKED WHAT PORTION OF THE DEVICE WAS MISSING, THE PHILIPS REPRESENTATIVE STATED THAT THE SYRINGE WAS MISSING. DUE TO LIMITED DETAIL, IT IS UNKNOWN HOW THE PATIENT WAS TREATED; HOWEVER, THE INFORMATION DID STATE THERE WAS NO PATIENT INJURY. THIS REPORT IS BEING SUBMITTED DUE TO THE POTENTIAL FOR SERIOUS INJURY WITH RECURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11289838 ↗
• DeathOct 1, 2018Solder Joint Fracture; Solder Joint Fracture

  DURING A CARDIAC LEAD MANAGEMENT SURGERY, MECHANICAL ASPIRATION WAS PERFORMED IN PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE SECOND DIAGONAL BRANCH, WITH RETRIEVAL OF MODERATE AMOUNTS OF THROMBOTIC DEBRIS. HOWEVER, DURING RETRIEVAL, THE QUICKCAT ASPIRATION CATHETER AND ANOTHER MANUFACTURER'S GUIDE WIRE SNAPPED, LEAVING PORTIONS OF THE QUICKCAT AND GUIDE WIRE WITHIN THE D2 BRANCH OF THE LAD. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE PORTIONS, USING A SNARE, WITHOUT SUCCESS. ANOTHER QUICKCAT CATHETER WAS USED TO ATTEMPT FURTHER ASPIRATION OF EMBOLI FROM THE AREA, AFTER ABOVE EVENT OCCURRED. PATIENT WAS VERY ILL PRIOR TO BEGINNING THE PROCEDURE (PRE-EXISTING CARDIOGENIC SHOCK, VENTRICULAR FIBRILLATION). IT WAS REPORTED THAT THE PATIENT WAS BEING SHOCKED (DEFIBRILLATOR USED) DURING THE PROCEDURE, AND IT IS UNKNOWN IF THE DEVICES WERE PRESENT IN THE PATIENT DURING THE TIME OF DEFIBRILLATION. THE PATIENT SURVIVED THE PROCEDURE, BUT PASSED AWAY THE FOLLOWING DAY.

  Patient problems: Cardiogenic Shock; Death; Foreign Body In Patient; Ventricular Fibrillation

  MAUDE report 7922781 ↗