Forté® AXP Access Sheath B7216Recalls & reported problems
Applied Medical Resources Corporation · Ureteral Dilating Catheter · Class 2
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 00607915113353), received between Aug 25, 2016 and Aug 25, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2016Break; Break
CYSTOSCOPY & RIGHT RETROGRADE PYELOGRAM & URETEROSCOPY: "END OF FORTE AP ACCESS SHEATH BROKE OFF, WEDGING IN THE URETER". TYPE OF INTERVENTION - ADDITIONAL INFORMATION RECEIVED VIA PHONE (B)(6) 2016: "DID REMOVE THE SMALL PIECE BUT DID LAZER THE PIECE TO REMOVE WHICH CAUSED SOME DAMAGE TO PIECE THAT FELL OFF." ADDITIONAL INFORMATION RECEIVED VIA E-MAIL (B)(6) 2016: ALL OF THE PIECES WERE COMPLETELY REMOVED FROM THE PATIENT. THE ACCESS SHEATH WAS PASSED OVER THE GUIDEWIRE TO THE ILIAC VESSEL LEVEL. THE OBTURATOR WAS REMOVED AND WIRE PASSED THROUGH THE OUTER SHEATH. ON REMOVING THE OUTER SHEATH THE PIECE WAS NOTED IN THE LOWER URETER ON SCREENING. THE PROCEDURE DID NOT CONTINUE AFTER THE REMOVAL OF THE FOREIGN BODY. ADDITIONAL INFORMATION RECEIVED VIA E-MAIL (B)(6) 2016: THE TIP WAS RETRIEVED WITH NO ADVERSE OUTCOMES FOR THE PATIENT. ADDITIONAL INFORMATION RECEIVED VIA E-MAIL (B)(6) 2016: THE SURGEON HAD TO USE A LASER TO REMOVE THE PIECE THAT HAD BROKEN OFF. THE PIECE WAS LODGED IN THE VESSEL. THIS RESULTED IN A STENT NEEDING TO BE PLACED IN THE AREA OF THE LASERED REMOVAL. IT WAS NOT DIRECTLY STATED THAT THE LASER CAUSED DAMAGE TO THE PIECE IN QUESTION, ONLY THAT A LASER WAS USED T
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5904017 ↗
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- Proxis™ Ureteral Access Sheath 231045C. R. Bard, Inc. · endoscopic access overtube, gastroenterology-urology22 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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