Flexor Parallel G56435Recalls & reported problems
Cook Incorporated · Flexor, Parallel Rapid Release Ureteral Access Sheath with AQ, Hydrophilic Coating · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002564350), received between Dec 3, 2018 and Sep 9, 2026 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Contamination” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Contamination1
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Laceration(s)1
- No Code Available1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
It was reported that while performing Ureteroscopy with laser procedure using FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS, the patient had small ureteral mucosal injury. The doctor used a stent to fix the issue and the patient was fine. The doctor thinks the injury occurred when they were pushing the sheath up the ureter. No other adverse effects were reported for this incident.
Patient problems: Laceration(s)
MAUDE report 50689001 ↗MalfunctionMar 18, 2026Device Contaminated During Manufacture or Shipping
IT WAS INITIALLY REPORTED THAT UPON DELIVERY OF A FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS, FOREIGN MATTER RESEMBLING DEBRIS WAS FOUND ATTACHED TO THE PRODUCT. THE FOREIGN MATTER WAS DISCOVERED BEFORE UNPACKING THE DEVICE. PRELIMINARY EVALUATION OF THE RETURNED DEVICE FOUND A TAN PARTICLE INSIDE THE TRAY OF THE SEALED PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24628387 ↗MalfunctionJul 12, 2021Contamination; Contamination
NO NEW INFORMATION TO REPORT THAT WAS NOT INCLUDED ON THE PREVIOUS MEDWATCH REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12149937 ↗InjuryDec 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THERE HAS BEEN NO NEW EVENT INFORMATION RECEIVED.
Patient problems: No Code Available
MAUDE report 8124207 ↗
Other endoscopic access overtube, gastroenterology-urology devices
- EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE OLYMPUS SIF TYPE Q180Olympus Medical Systems Corp. · endoscopic access overtube, gastroenterology-urology1 recall42 reports
- Trokamed WA2PS20STROKAMED GmbH · Endoscopic Access Overtube, Gastroenterology-Urology1 recall2 deaths2 reports
- Trokamed WA2PS20LTROKAMED GmbH · Endoscopic Access Overtube, Gastroenterology-Urology1 recall2 deaths2 reports
- Trokamed WA2PS18LTROKAMED GmbH · Endoscopic Access Overtube, Gastroenterology-Urology1 recall0 reports
- Trokamed WA2PS18STROKAMED GmbH · Endoscopic Access Overtube, Gastroenterology-Urology1 recall0 reports
- Navigator HD M0062502220Boston Scientific Corporation · endoscopic access overtube, gastroenterology-urology1 death31 reports
- Navigator HD M0062502230Boston Scientific Corporation · endoscopic access overtube, gastroenterology-urology29 reports
- Proxis™ Ureteral Access Sheath 231045C. R. Bard, Inc. · endoscopic access overtube, gastroenterology-urology22 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.