GP General Purpose Drainage Catheter GPL2-1030HRecalls & reported problems
Uresil, LLC · HYDROPHILIC COATED GP LOCKING CATHETER WITH DEPTH MARKS, 10F · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H862GPL21030H0), received between Sep 10, 2019 and Sep 10, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
Patient problems
- Pneumothorax1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2019Fracture; Fracture
A URESIL DRAINAGE CATHETER WAS PLACED IN THE PATIENT AS A CHEST DRAINAGE TUBE ON (B)(6) 2019. THE NEXT DAY ((B)(6) 2019), A LEAK WAS DETECTED AND THE CATHETER WAS FOUND TO BE BLOCKED. THE CATHETER WAS FLUSHED WITH SALINE AND HUB LEAKAGE WAS AGAIN NOTED. EVEN THOUGH THE HOSPITAL WAS AWARE OF THIS LEAK, THE CATHETER WAS NOT REPLACED UNTIL 2 DAYS LATER - (B)(6) 2019. THE HOSPITAL ALSO STATED THAT THEY INTENTIONALLY "OVER-TIGHTEN" THESE TYPES OF CATHETER CONNECTIONS, AND MOST LIKELY USED A METAL INSTRUMENT TO OVER-TIGHTEN THE CONNECTION. THE HOSPITAL RECOGNIZES THAT THE LEAKING CATHETER SITUATION SHOULD HAVE BEEN ADDRESSED SOONER, AND IT IS URESIL'S UNDERSTANDING THAT THEY INTEND TO CHANGE THEIR INTERNAL PROCEDURES REGARDING TIMELY ADDRESSING OF NOTED ISSUES LIKE LEAKING DEVICES AND TO NOT USE METAL INSTRUMENTS TO TIGHTEN CONNECTIONS.
Patient problems: Pneumothorax
MAUDE report 8981077 ↗
Other Catheter, Nephrostomy, General & Plastic Surgery devices
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- 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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