GP General Purpose Drainage Catheter GPL2-0830HRecalls & reported problems
Uresil, LLC · HYDROPHILIC COATED GP LOCKING CATHETER WITH DEPTH MARKS, 8F · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H862GPL20830H0), received between Jun 8, 2018 and Jun 8, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment Of Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Detachment Of Device Component1
- Migration or Expulsion of Device1
Patient problems
- Foreign Body In Patient1
- Staphylococcus Aureus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2018Detachment Of Device Component; Migration or Expulsion of Device; Detachment Of Device Component; Migration or Expulsion of Device
STRESS RELIEF WAS DISCOVERED AS HAVING BEEN RETAINED IN THE PATIENT'S RENAL PELVIS DURING A ULTRASOUND; STRESS RELIEF WAS SUBSEQUENTLY SUCCESSFULLY REMOVED THROUGH SURGICAL INTERVENTION ON OR SHORTLY BEFORE (B)(6) 2018. STRESS RELIEF WAS DETERMINED BY HOSPITAL TO HAVE BEEN RELATED TO A NEPHROSTOMY DRAINAGE PROCEDURE BETWEEN (B)(6) 2017 USING A URESIL GPL2-0830H. BASED ON SHIPMENT RECORDS, THE URESIL DISTRIBUTOR AND HOSPITAL BELIEVE THE PRODUCT TO BE LOT 6F494 OR 6H652.
Patient problems: Foreign Body In Patient; Staphylococcus Aureus
MAUDE report 7584451 ↗
Other Catheter, Nephrostomy, General & Plastic Surgery devices
- NA M0067001210Boston Scientific Corporation · CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY2 deaths48 reports
- NA M0064201110Boston Scientific Corporation · CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY6 reports
- Flexima™ M001271800Boston Scientific Corporation · CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY6 reports
- Skater™ All-Purpose and Nephrostomy Set 756608025Argon Medical Devices, Inc. · Catheter, Nephrostomy, General & Plastic Surgery5 reports
- Flexima™ M001271790Boston Scientific Corporation · CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY4 reports
- Re-Entry Malecot Nephrostomy Catheter Set M0064101060Boston Scientific Corporation · CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY4 reports
- SKATER™ All Purpose and Nephrostomy Drainage Set 756608035Argon Medical Devices, Inc. · Catheter, Nephrostomy, General & Plastic Surgery4 reports
- Flexima™ M001271860Boston Scientific Corporation · CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY2 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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