Flexor ParallelRecalls & reported problems across all models
Cook Incorporated · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 51
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 0
We found 8 models of Flexor Parallel by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 51 adverse event reports in the FDA's MAUDE database, received between Oct 24, 2016 and Sep 9, 2026 — classified as 6 injuries, 45 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (22 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Flexor Parallel problems
Device problems
- Peeled/Delaminated22
- Unsealed Device Packaging4
- Adverse Event Without Identified Device or Use Problem3
- Difficult to Advance3
- Appropriate Device Problem Term/Code Not Available2
- Device Contaminated During Manufacture or Shipping2
- Device Contamination with Chemical or Other Material2
- Device Operates Differently Than Expected2
Patient problems
- No Clinical Signs, Symptoms or Conditions31
- No Known Impact Or Consequence To Patient5
- Foreign Body In Patient4
- No Code Available4
- No Consequences Or Impact To Patient4
- Insufficient Information3
- Injury1
- Internal Organ Perforation1
Flexor Parallel models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Flexor Parallel G34874endoscopic access overtube, gastroenterology-urology21 reports
- Flexor Parallel G56436endoscopic access overtube, gastroenterology-urology14 reports
- Flexor Parallel G34873endoscopic access overtube, gastroenterology-urology5 reports
- Flexor Parallel G56435endoscopic access overtube, gastroenterology-urology4 reports
- Flexor Parallel G34872endoscopic access overtube, gastroenterology-urology2 reports
- Flexor Parallel G56430endoscopic access overtube, gastroenterology-urology2 reports
- Flexor Parallel G56438endoscopic access overtube, gastroenterology-urology2 reports
- Flexor Parallel G56431endoscopic access overtube, gastroenterology-urology1 report
Recent Flexor Parallel adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionFeb 24, 2026Peeled/Delaminated
IT WAS REPORTED, THE ACCESS SHEATH FROM A FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS FRAYED WHEN THE EXTRACTOR BASKET WAS PASSED THROUGH IT TO CAPTURE AND REMOVE KIDNEY STONES. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24429643 ↗MalfunctionDec 31, 2025Peeled/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 23936251 ↗MalfunctionDec 16, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE INNER LINER OF THE SHEATH OF A FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS DELAMINATED DURING A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE. WHEN ADVANCING THE URETEROSCOPE THROUGH THE SHEATH, THE USER OBSERVED THE SURFACE OF THE INNER LINER OF THE SHEATH FRAYING. THE USER ALSO NOTED THE 'INTERNAL COATING' PEELING. THE DEVICE WAS REPLACED WITH A NEW, SIMILAR-LIKE DEVICE TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824891 ↗MalfunctionAug 22, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED, A THREAD-LIKE OBJECT, WHICH APPEARED TO BE PEELED COATING, WAS OBSERVED PROTRUDING FROM THE SHEATH OF THE FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS. THE ISSUE WAS IDENTIFIED AFTER THE ENDOSCOPE WAS INSERTED THROUGH THE ACCESS SHEATH DURING AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22871050 ↗MalfunctionAug 20, 2025Peeled/Delaminated; Peeled/Delaminated
INFORMATION KNOWN PRIOR TO SENDING THE INITIAL MDR, BUT INADVERTENTLY NOT INCLUDED IN THE INITIAL MDR: A SECOND SHEATH FROM A FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS WAS USED AND THE DISPOSABLE ENDOSCOPE SCREEN SHOWED SOMETHING THAT LOOKED LIKE PEELING AROUND THE SHEATH TIP. THE PROCEDURE WAS COMPLETED WITH THE SECOND DEVICE. THERE WAS NO MATERIAL THAT NEEDED TO BE REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22852335 ↗MalfunctionJul 31, 2025Peeled/Delaminated; Peeled/Delaminated
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information
MAUDE report 22676336 ↗MalfunctionJun 17, 2025Peeled/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 22238802 ↗MalfunctionApr 22, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED; WHITE FOREIGN MATTER WAS OBSERVED IN THE SHEATH OF A FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATOR DURING TRANSURETHRAL URINARY LITHOTRIPSY (TUL). A WIRE GUIDE WAS PLACED IN THE RENAL PELVIS, AND THE SHEATH WAS INSERTED INTO THE URETER. AFTER THE SHEATH'S DILATOR WAS REMOVED AND A DISPOSABLE URETEROSCOPE WAS INSERTED INTO THE SHEATH, MULTIPLE WHITE THREAD-LIKE FOREIGN MATTER WAS OBSERVED IN THE SHEATH VIA THE ENDOSCOPIC IMAGE. THE PROCEDURE WAS COMPLETED BY REMOVING THE FOREIGN MATTER WITH GRASPING FORCEPS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY OTHER 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 21883771 ↗MalfunctionApr 1, 2025Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THE FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS¿ PACKAGE WAS FOUND UNSEALED DURING AN UNSPECIFIED PROCEDURE. UPON OPENING THE PACKAGE, THE SHEATH SLIPPED OUT REPORTEDLY DUE TO A MISSING SEAM. IT WAS NOT USED. A NEW SHEATH WAS OPENED TO COMPLETE THE PROCEDURE. THERE IS NO ADDITIONAL INFORMATION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21741766 ↗MalfunctionMar 31, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED RESISTANCE WAS FELT DURING INSERTION OF A FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS¿ SHEATH IN THE COURSE OF A TRANSURETHRAL LITHOTOMY (TUL) PROCEDURE. DURING INSERTING AND REMOVING ANOTHER MANUFACTURER'S ENDOSCOPE (OUTER DIAMETER 8.5 FR) INTO THE SHEATH, RESISTANCE GRADUALLY BEGAN TO BE FELT, AND FIBROUS LIKE FOREIGN MATTER WAS NOTED COMING OUT OF THE SHEATH. NORMALLY, THE SUPPLIED DILATOR WOULD NOT BE INSERTED INTO A SHEATH AT THIS POINT, BUT THERE WAS AN ISSUE WITH THE LUMEN, SO THE PHYSICIAN ATTEMPTED TO INSERT IT TO CHECK IF THE LUMEN WAS OPEN. THE DILATOR COULD NOT BE INSERTED. THE COATING INSIDE THE SHEATH APPEARS TO HAVE PEELED OFF. REPORTEDLY, THIS IS THE FIRST TIME THAT THE ISSUE WAS NOTED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. 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 21731448 ↗MalfunctionMar 31, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED RESISTANCE WAS FELT DURING INSERTION OF A FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS¿ SHEATH IN THE COURSE OF A TRANSURETHRAL LITHOTOMY (TUL) PROCEDURE. THE PHYSICIAN INSERTED AND REMOVED AN ENDOSCOPE THROUGH THE SHEATH, WHICH WAS PLACED IN THE URETER, FELT RESISTANCE, AND DISCONTINUED ITS USE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. A CUSTOMER PROVIDED PICTURE APPEARS TO SHOW THE SHEATH HAD DELAMINATED. 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 21730232 ↗MalfunctionFeb 21, 2025Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED, THE NURSE WENT TO OPEN THE PACKAGE OF A FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS AND NOTICED THE SEAL WAS OPEN. THE DEVICE WAS FOUND PRIOR TO PATIENT CONTACT. ANOTHER SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE. A PHOTO OF WHAT APPEARS TO SHOW UNSEALED DEVICE PACKAGING WAS ATTACHED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21439143 ↗MalfunctionDec 3, 2024Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED, THE FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS' PACKAGE WAS NOT SEALED PROPERLY AND THE DEVICE "FELL OUT". THE ISSUE WAS DISCOVERED WHILE THE DEVICE WAS IN THE WAREHOUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20836075 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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