Amplatz Type Renal Sheath M0069001230Recalls & reported problems
Boston Scientific Corporation · Amplatz Type Renal Sheath · Class U
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 08714729431671), received between Jun 16, 2017 and Jun 16, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Advance” (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
- Difficult to Advance1
Patient problems
- Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 16, 2017Difficult to Advance; Difficult to Advance
NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT 3005099803-2017-01812 ADDRESSES THE NEPHROMAX DILATATION BALLOON, WHILE ADDRESSES THE AMPLATZ RENAL SHEATH. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX DILATATION BALLOON WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THEY USED A 20 CM AMPLATZ RENAL SHEATH, IT WOULD NOT SLIDE OVER THE NEPHROMAX DILATATION BALLOON. AS THEY PUSHED TO SLIDE THE SHEATH OVER THE BALLOON, THE BALLOON ADVANCED AND PERFORATED THE RENAL PELVIS. IT IS UNKNOWN IF THERE WAS ADDITIONAL INTERVENTION PERFORMED FOR THE PUNCTURED RENAL PELVIS. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. POST PROCEDURE, THERE WERE NO COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.
Patient problems: Perforation
MAUDE report 6646212 ↗
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
- Dawson Mueller G13768Cook Incorporated · CATHETER, NEPHROSTOMY59 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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