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Flexor Parallel G56430Recalls & reported problems

Cook Incorporated · Flexor, Parallel Rapid Release Ureteral Access Sheath with AQ, Hydrophilic Coating · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002564305), received between Mar 10, 2017 and Jul 8, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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

Device problems

  • Device Operates Differently Than Expected1
  • Peeled/Delaminated1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJul 8, 2021Peeled/Delaminated; Peeled/Delaminated

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

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12140194 ↗
  • MalfunctionMar 10, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

    IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT A URETEROSCOPY PROCEDURE ON (B)(6) 2017. THE ATTENDING PHYSICIAN INDICATED THAT THE SHEATH CAME IN CONTACT WITH THE PATIENT. THE PRE-SPLIT TIP ON THE FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS DID NOT SEPARATE AS IT WAS INTENDED TO. THE OBTURATOR COULD NOT BE REMOVED THEREFORE, THE UROLOGIST HAD TO REMOVE THE SHEATH AND THE WIRE GUIDE COMPLETELY AND OBTAIN A NEW SHEATH. THE SECOND SHEATH WAS OPENED AND TESTED PRIOR TO MAKING PATIENT CONTACT AND EXHIBITED THE SAME DIFFICULTY WITH THE TIP. A THIRD SHEATH WAS OPENED WITH NO COMPLICATIONS AND THE PROCEDURE WAS ABLE TO BE COMPLETED AS EXPECTED. THERE WERE NO UNINTENDED SECTIONS OF THE DEVICE THAT REMAINED INSIDE OF THE PATIENT¿S BODY, NOR DID THE PATIENT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6394536 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.