NA M0062601500Recalls & reported problems
Boston Scientific Corporation · Amplatz Type Renal Sheath Set · Class U · Implant
Data updated Oct 16, 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 08714729005568), received between Aug 22, 2024 and Aug 22, 2024 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Fever1
- Hemorrhage/Blood Loss/Bleeding1
- Sepsis1
- Urinary Incontinence1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE UROLOGIA JOURNAL THAT A STUDY WAS CONDUCTED TO DESCRIBE THE TECHNIC TO PERFORM TUBELESS PERCUTANEOUS NEPHROLITHOTOMY (TPCNL) TO EVALUATE THE PROCEDURE EFFICACY AND SAFETY. TPCNL PROCEDURE UTILIZED HEMOSTATIC MATRIX THAT IS FLOSEAL FOR THE CLOSURE OF THE PERCUTANEOUS TRACT, DEVELOPED THROUGH EXPERIENCED AT THE ENDOUROLOGY SPECIALIZED CENTER, OSPEDALE DI CAMPOSAMPIERO. DATA FROM PATIENTS CONSECUTIVELY TREATED FROM FEBRUARY 2017 TO DECEMBER 2019 FOR KIDNEY STONE >2 CM VIA PCNL, WHO UNDERWENT FLOSEAL DIRECT APPLICATION FOR PERCUTANEOUS TRACT CLOSURE, WERE INCLUDED. CLINICAL AND SURGICAL DATA WERE COLLECTED IN ORDER TO EVALUATE THE SUCCESS OF THE PROCEDURE AND POSSIBLE COMPLICATIONS. PREOPERATIVE ASSESSMENT DECLARED THAT PROCEDURES WERE PERFORMED UNDER SPINAL ANESTHESIA IN 69 PATIENTS (45 MALES MEAN AGE 58 YEARS OLD). FOR THE PROCEDURE TECHNIQUE, THE BOSTON SCIENTIFIC SENSOR PTFE-NITINOL GUIDEWIRE WITH HYDROPHILIC TIP, AMPLATZ SUPER STIFF GUIDEWIRE, NEPHROMAX BALLOON DILATOR, AND AMPLATZ RENAL SHEATH WERE UTILIZED. FOR THE LITHOTRIPSY PROCEDURES OF THE TONE, THE BOSTON SCIENTIFIC LUMENIS 20W HOLMIUM LASER, AND A ZERO T
Patient problems: Fever; Hemorrhage/Blood Loss/Bleeding; Sepsis; Urinary Incontinence
MAUDE report 20035028 ↗
Other CATHETER, NEPHROSTOMY devices
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- Dawson Mueller G09705Cook Incorporated · CATHETER, NEPHROSTOMY2 deaths215 reports
- Cook G09497Cook Incorporated · CATHETER, NEPHROSTOMY129 reports
- Dawson Mueller G11020Cook Incorporated · CATHETER, NEPHROSTOMY100 reports
- Cook G09502Cook Incorporated · CATHETER, NEPHROSTOMY86 reports
- NephroMax Kit M0062101180Boston Scientific Corporation · CATHETER, NEPHROSTOMY1 recall25 reports
- NephroMax Kit M0062101600Boston Scientific Corporation · CATHETER, NEPHROSTOMY1 recall11 reports
- Cook G09767Cook Incorporated · CATHETER, NEPHROSTOMY1 recall9 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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