Cook Spectrum G53602Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002536029), received between Feb 3, 2017 and Apr 27, 2018 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionApr 27, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE GUIDE WIRE FROM COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED DOUBLE LUMEN CENTRAL VENOUS CATHETER SET COULD NOT BE PLACED SMOOTHLY DURING SUBCLAVIAN PROCEDURE. THE DOCTOR WITHDREW THE GUIDE WIRE AND WANTED TO RESET PRODUCT, BUT THE GUIDE WIRE WAS BENDING. A GUIDE WIRE FROM A DIFFERENT SET WAS USED BUT IT TOO BECAME STUCK AFTER PUSHING THE GUIDE WIRE INSIDE. A GUIDE WIRE FROM A THIRD SET WAS USED WITH NO ISSUES. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES AND DID NOT EXPERIENCE ANY ADVERSE EVENTS. TWO WIRE GUIDES FROM THE COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED DOUBLE LUMEN CENTRAL VENOUS CATHETER SETS WERE RETURNED FOR INVESTIGATION. A VISUAL INSPECTION OF THE FIRST WIRE CONFIRMED MULTIPLE KINKS IN THE COIL. IT WAS ALSO DISCOVERED SEPARATION OF THE SAFETY FROM THE WELD CONNECTION, OPPOSITE OF THE J-CURVE, RESULTING IN COIL ELONGATION AND SAFETY WIRE PROTRUSION. THE WELD CONNECTION AT THE END OF THE SEPARATION WAS PRESENT AND ATTACHED TO THE COIL. A VISUAL EXAMINATION OF THE SECOND WIRE CONFIRMED TWO BENDS IN THE COIL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7467752 ↗
• MalfunctionSep 26, 2017Device Inoperable

  GUIDE WIRE WAS UNABLE TO BE SMOOTHLY PLACED, THE GUIDE UNCOILED WHEN WITHDRAWN, AND CANNOT BE USED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6894660 ↗
• MalfunctionMar 15, 2017Unraveled Material; Unraveled Material

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT UNDERWENT PLACEMENT OF A SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED DOUBLE LUMEN CENTRAL VENOUS CATHETER FOR AN UNSPECIFIED INDICATION. THE DEVICE WAS IMPLANTED INTO THE RIGHT SUBCLAVIAN VEIN. THE GUIDEWIRE BEGAN TO KINK AND BEND WHILE THE OPERATOR ATTEMPTED TO REMOVE THE GUIDEWIRE FOLLOWING SUCCESSFUL PLACEMENT OF THE CATHETER. A PORTION OF THE WIRE ALLEGEDLY CAME LOOSE IN THE MID TO PROXIMAL PORTION. THE SITE WAS RECANNULATED AND THE PROCEDURE COMPLETED. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THERE ARE NO REPORTS OF ANY UNINTENDED SECTIONS OF DEVICE RETAINED WITHIN THE PATIENT. THE SPECIFIC HANDLING, CONDITIONS AND CIRCUMSTANCES SURROUNDING THE EVENT ARE NOT KNOWN. THE INSTRUCTIONS FOR USE (IFU) THAT ACCOMPANY THE DEVICE STATE:" IF RESISTANCE IS ENCOUNTERED DURING WIRE GUIDE INSERTION, DO NOT FORCE WIRE GUIDE. WITHDRAWAL OF WIRE GUIDE THROUGH NEEDLE SHOULD BE AVOIDED; BREAKAGE MAY RESULT." THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6406272 ↗
• InjuryFeb 3, 2017Material Separation; Material Separation

  INTERNATIONAL CUSTOMER REPORTED THAT THE PHYSICIAN WAS PLACING A CENTRAL VENOUS CATHETER THROUGH A RIGHT SUBCLAVIAN APPROACH. THE ATTENDING PHYSICIAN BEGAN TO REMOVE THE GUIDE WIRE THROUGH THE CATHETER AT WHICH TIME THE GUIDE WIRE BECAME "LOOSE" ALONG THE MID TO PROXIMAL PORTION OF THE WIRE. THE CUSTOMER INDICATED THAT AN ADDITIONAL RECANNULATION PROCEDURE WAS PERFORMED TO COMPLETE THE IMPLANTATION OF THE CENTRAL VENOUS CATHETER.

  Patient problems: No Code Available

  MAUDE report 6301499 ↗