Harrison G16766Recalls & reported problems
Cook Incorporated · Harrison Fetal Bladder Stent Set · Class f · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00827002167667), received between Dec 3, 2019 and Aug 4, 2026 — classified as 4 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Difficult to Advance” (7 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.
Reports received per month
Most reported problems
Device problems
- Difficult to Advance7
- Off-Label Use3
- Failure to Advance2
- Separation Failure2
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- No Code Available1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 4, 2026Failure to Advance
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 50129329 ↗MalfunctionApr 30, 2026Difficult to Advance
IT WAS REPORTED THAT THE HARRISON FETAL BLADDER STENT SET WAS DIFFICULT TO ADVANCE DURING A LEFT PLEURO-AMNIOTIC DRAINAGE PROCEDURE FOR A 34-YEAR-OLD, FEMALE PATIENT THAT WAS 22 WEEKS AND 2 DAYS OF GESTATION. THE PATIENT WAS ADMITTED FOR AN IN-UTERO PLACEMENT OF A LEFT PLEURO-AMNIOTIC DRAINAGE TUBE IN THE CONTEXT OF HYDROTHORAX. DURING THE PROCEDURE, THE USER WAS NOT ABLE INSERT THE PLEURAL DRAIN WITH THE STYLET ATTACHED INTO THE TROCAR. A NEW SIMILAR-LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS TESTED PRIOR TO USE. 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 25046942 ↗MalfunctionJan 28, 2026Difficult to Advance
AS REPORTED, PRIOR TO PATIENT CONTACT DURING AN UNKNOWN PROCEDURE, THE STAINLESS WIRE POSITIONER INCLUDED IN THE 'HARRISON FETAL BLADDER STENT SET' DID NOT PASS THROUGH THE TROCAR NEEDLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING IT WITH ANOTHER 'HARRISON FETAL BLADDER STENT SET' FROM A DIFFERENT LOT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24202512 ↗MalfunctionNov 18, 2025Difficult to Advance; Difficult to Advance
IT WAS REPORTED, PRIOR TO PATIENT CONTACT, THE STENT POSITIONER OF A HARRISON FETAL BLADDER STENT SET WOULD NOT PASS THROUGH THE TROCAR NEEDLE. ANOTHER SAME DEVICE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE UNSPECIFIED PROCEDURE. IT WAS REPORTED THAT ONE DEVICE WAS "UNPACKED" AND 3 DEVICE PACKAGES WERE OPENED. IT IS UNCLEAR IF THEY EXPERIENCED THIS ISSUE WITH ONE DEVICE OR FOUR DEVICES. 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 23587274 ↗MalfunctionJun 30, 2025Difficult to Advance; Difficult to Advance
IT WAS REPORTED THE HARRISON FETAL BLADDER STENT SET¿S WIRE POSITIONER DID NOT PASS THROUGH THE TROCAR NEEDLE. THE ISSUE WAS FOUND DURING THE PRE-OPERATIVE PREPARATION; THE PATIENT WAS UNDER ANESTHESIA (OR SEDATION), NO DAMAGE WAS NOTED ON THE DEVICE. THE SURGERY WAS CANCELED AND RE-SCHEDULED FOR ANOTHER DAY BECAUSE THERE WAS NOT ANOTHER BLADDER STENT AVAILABLE AT THE HOSPITAL. THE RE-SCHEDULED SURGERY WAS SUCCESSFULLY PERFORMED BY USING ANOTHER SAME-TYPE 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 22357134 ↗MalfunctionAug 5, 2024Difficult to Advance; Difficult to Advance
IT WAS REPORTED THE HARRISON FETAL BLADDER STENT SET'S PIGTAIL BECAME STUCK WHEN INSERTED INTO THE NEEDLE, PRIOR TO AN UNSPECIFIED PROCEDURE. THE DEVICE WAS UNABLE TO BE USED AFTER BECOMING STUCK IN THE NEEDLE AND THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE DEVICE DID NOT MAKE PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19910046 ↗MalfunctionOct 1, 2023Off-Label Use; Failure to Advance; Off-Label Use; Failure to Advance
AS REPORTED, DURING VILLUS CHORIONIC SAMPLING, THREE HARRISON FETAL BLADDER STENTS GOT STUCK IN THE NEEDLE/TROCAR. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17849351 ↗InjurySep 8, 2023Off-Label Use; Separation Failure; Off-Label Use; Separation Failure
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 17714051 ↗InjurySep 8, 2023Off-Label Use; Separation Failure; Off-Label Use; Separation Failure
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 17714045 ↗InjuryMay 19, 2021Difficult to Advance; Difficult to Advance
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11853154 ↗InjuryDec 3, 2019Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent
NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN PROVIDED SINCE THE LAST REPORT WAS SUBMITTED ON 03DEC2019.
Patient problems: No Code Available
MAUDE report 9402556 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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