ADROIT 67271700Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032071328), received between Aug 22, 2017 and Aug 22, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K131225); they may or may not involve this specific model.

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 18, 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.

• MalfunctionAug 22, 2017Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION WAS RECEIVED AND THERE WAS DIFFICULTY INSERTING THE ADROIT GUIDING CATHETER WITHIN THE RADIAL ARTERY. THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS A STANDARD ANGIOGRAM USING THE RBL 4.0 SHAPED CATHETER TO VIEW BOTH LEFT & RIGHT CORONARY ARTERIES. NO PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE WAS REQUIRED FOR THIS PATIENT. FIVE CASES CONDUCTED SUCCESSFULLY WITH RESISTANCE EXPERIENCED IN THREE OF THE FIVE CASES. THE INSERTION DIFFICULTY WAS NOT CAUSED BY A BLOCKAGE OF POSSIBLY INJECTABLE MATERIAL. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTION FOR USE (IFU) WITH NO DEFECTS OR DIFFICULTY NOTED. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEAR TO BE NORMAL. THE PRODUCT WAS PROPERLY FLUSHED AND INSPECTED PRIOR TO USE. THE SHEATH DID NOT KINKED OR BENT DURING PREP OR DURING INSERTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6811418 ↗
• MalfunctionAug 22, 2017Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION WAS RECEIVED AND THERE WAS DIFFICULTY INSERTING THE ADROIT GUIDING CATHETER WITHIN THE RADIAL ARTERY. THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS A STANDARD ANGIOGRAM USING THE RBL 4.0 SHAPED CATHETER TO VIEW BOTH LEFT & RIGHT CORONARY ARTERIES. NO PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE WAS REQUIRED FOR THIS PATIENT. FIVE CASES CONDUCTED SUCCESSFULLY WITH RESISTANCE EXPERIENCED IN THREE OF THE FIVE CASES. THE INSERTION DIFFICULTY WAS NOT CAUSED BY A BLOCKAGE OF POSSIBLY INJECTABLE MATERIAL. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTION FOR USE (IFU) WITH NO DEFECTS OR DIFFICULTY NOTED. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEAR TO BE NORMAL. THE PRODUCT WAS PROPERLY FLUSHED AND INSPECTED PRIOR TO USE. THE SHEATH DID NOT KINKED OR BENT DURING PREP OR DURING INSERTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6811387 ↗
• MalfunctionAug 22, 2017Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION WAS RECEIVED AND THERE WAS DIFFICULTY INSERTING THE ADROIT GUIDING CATHETER WITHIN THE RADIAL ARTERY. THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS A STANDARD ANGIOGRAM USING THE RBL 4.0 SHAPED CATHETER TO VIEW BOTH LEFT & RIGHT CORONARY ARTERIES. NO PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE WAS REQUIRED FOR THIS PATIENT. FIVE CASES CONDUCTED SUCCESSFULLY WITH RESISTANCE EXPERIENCED IN THREE OF THE FIVE CASES. THE INSERTION DIFFICULTY WAS NOT CAUSED BY A BLOCKAGE OF POSSIBLY INJECTABLE MATERIAL. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTION FOR USE (IFU) WITH NO DEFECTS OR DIFFICULTY NOTED. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEAR TO BE NORMAL. THE PRODUCT WAS PROPERLY FLUSHED AND INSPECTED PRIOR TO USE. THE SHEATH DID NOT KINKED OR BENT DURING PREP OR DURING INSERTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6811353 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131225. One submission often covers many models, so check the product and lot details in each record.

• Z-0003-2014 · Aug 12, 2013 · Terminated
  Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.