Cook G06425Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002064256), received between Nov 28, 2017 and May 24, 2019 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 24, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Patient Involvement

  MAUDE report 8640245 ↗
• MalfunctionAug 24, 2018Unraveled Material; Unraveled Material

  IT WAS REPORTED, THE MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET DISPLAYED "AN EXCESSIVE ELASTIC ELONGATION WITH RISK OF RUPTURE" UPON REMOVAL FROM THE PATIENT'S ANATOMY. DURING THE PROCEDURE TO TREAT A RIGHT FEMORAL-POPLITEAL OBSTRUCTION WITH LOCAL FIBRINOLYTIC TREATMENT, THERE WAS DIFFICULTY IN ADVANCING THE COMPLAINT DEVICE FROM THE HUMERAL ACCESS TO THE RIGHT FEMORAL-POPLITEAL OBSTRUCTION. PER THE COMPLAINANT, THE PATIENT HAD DIFFUSE AORTIC AND ILIAC CALCIFICATIONS BUT NO TORTUOSITY OF THE VASCULATURE. AFTER REMOVAL OF THE COMPLAINT DEVICE, THE PROCEDURE WAS COMPLETED USING A SECOND CATHETER OF THE SAME TYPE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ACCORDING TO THE COMPLAINANT, THE COMPLAINT DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7814063 ↗
• MalfunctionMar 1, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING INSPECTION OF THE MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET, IT WAS OBSERVED THAT THERE WAS A HAIR INSIDE OF THE PRIMARY PACKAGE. THE DEVICE WAS NOT USED AND DID NOT COME INTO CONTACT WITH A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7305829 ↗
• InjuryNov 28, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING LOWER EXTREMITY THROMBOLYSIS, AS THE MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET CATHETER WAS BEING REMOVED, THE MARKER BANDS SEPARATED FROM THE CATHETER SHAFT AND STOPPED IN THE TIBIAL ARTERIES - ONE IN THE ANTERIOR AND ONE IN THE POSTERIOR. THE PATIENT EXPERIENCED ACUTE THROMBOSIS OF THE POSTERIOR AND ANTERIOR TIBIAL ARTERIES AS A RESULT OF THIS EVENT. THE MARKER BANDS WERE ABLE TO BE SUCCESSFULLY REMOVED WITH ADDITIONAL THROMBOLYSIS USING A DISTAL EMBOLIZATION PROTECTION DEVICE WITH A CAROTID BALLOON CATHETER.

  Patient problems: No Code Available

  MAUDE report 7064070 ↗