C-Flex G17306Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002173064), received between Nov 22, 2016 and Jan 12, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2023Peeled/Delaminated; Material Separation; Unraveled Material; Peeled/Delaminated; Material Separation; Unraveled Material

  TWO COMPLAINT DEVICES WERE RETURNED TO COOK FOR INVESTIGATION, HOWEVER, COOK IS UNABLE TO DETERMINE WHICH WIRE IS FOR WHICH COMPLAINT DUE TO THEM BEING RETURNED IN THE SAME PACKAGE. THE FIRST WIRE (MANUFACTURER REPORT # 1820334-2023-00025) WAS RETURNED UNRAVELED. THE SECOND WIRE (CAPTURED UNDER THIS COMPLAINT) WAS RETURNED UNRAVELED AND SEPARATED.

  Patient problems: Insufficient Information

  MAUDE report 16154582 ↗
• MalfunctionJan 12, 2023Peeled/Delaminated; Unraveled Material; Peeled/Delaminated; Unraveled Material

  TWO COMPLAINT DEVICES WERE RETURNED TO COOK FOR INVESTIGATION, HOWEVER, COOK IS UNABLE TO DETERMINE WHICH WIRE IS FOR WHICH COMPLAINT DUE TO THEM BEING RETURNED IN THE SAME PACKAGE. THE FIRST WIRE (CAPTURED UNDER THIS COMPLAINT) WAS RETURNED UNRAVELED. THE SECOND WIRE (CAPTURED UNDER MANUFACTURER REPORT # 1820334-2023-00026) WAS RETURNED UNRAVELED AND SEPARATED.

  Patient problems: Insufficient Information

  MAUDE report 16154536 ↗
• MalfunctionOct 6, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, ONE END OF A C-FLEX MULTI-LENGTH URETERAL STENT WAS OBSERVED TO BE SPLIT WHEN OPENING THE PACKAGE. THE DEVICE DID NOT MAKE PATIENT CONTACT. A NEW STENT WAS USED TO CONTINUE THE PROCEDURE WITHOUT ISSUE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15549355 ↗
• MalfunctionJun 20, 2017Device Damaged Prior to Use; Device Damaged Prior to Use

  THE CUSTOMER REPORTED THAT C-FLEX MULTI-LENGTH URETERAL STENT SET WAS FOUND BROKEN WHEN THE PACKAGE WAS OPENED. THE DEVICE DID NOT COME IN CONTACT WITH THE PATIENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 6653820 ↗
• MalfunctionNov 22, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

  A (B)(6) PATIENT UNDERWENT PYLOPLASTY. THE DISTAL PIGTAIL HAD MEMORY LOSS CAUSING THE STENT TO MIGRATE UP THE RIGHT URETER. THE STENT WAS REMOVED WITH NO REPLACEMENT REQUIRED. THE STENT WAS INSITU FOR 6 WEEKS. DURING THE ORIGINAL PLACEMENT OF THE STENT, THE SURGEON WAS HAPPY WITH THE PLACEMENT OF BOTH PIGTAILS. THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES DUE TO THIS EVENT. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6122579 ↗