Ahmed™ ClearPath 350Recalls & reported problems
New World Medical, Incorporated · Glaucoma shunt · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00892064002355), received between Jul 13, 2020 and Aug 7, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Use of Device Problem1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2020Use of Device Problem; Use of Device Problem
THE CLEARPATH 350 BROKE DURING INSERTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10381299 ↗MalfunctionJul 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AFTER THE SHUNT WAS PLACED IN THE EYE AND THE SURGEON TIGHTENED THE 7-0 VICRYL SUTURE, THE TAIL DETACHED. THIS WAS FOR A CLEARPATH MODEL CP350. DATE OF EVENT NOT PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10268314 ↗
Other IMPLANT, EYE VALVE devices
- XEN Glaucoma Treatment System 5513-001Allergan, Inc. · Implant, Eye Valve280 reports
- Ahmed™ Glaucoma Valve FP7New World Medical, Incorporated · IMPLANT, EYE VALVE266 reports
- iStent Infinite iS3Glaukos Corporation · Implant, Eye Valve38 reports
- BAERVELDT GLAUCOMA IMPLANT (350) BG101350Johnson & Johnson Surgical Vision, Inc. · IMPLANT, EYE VALVE35 reports
- iStent infinite iS3Glaukos Corporation · Implant, Eye Valve21 reports
- BAERVELDT GLAUCOMA IMPLANT (250) BG103250Johnson & Johnson Surgical Vision, Inc. · IMPLANT, EYE VALVE16 reports
- EX-PRESS® P-50Alcon Laboratories, Inc. · Implant, Eye Valve12 reports
- Ahmed™ ClearPath 250New World Medical, Incorporated · IMPLANT, EYE VALVE6 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.
How reports and recalls are matched · Editorial policy · Report an error on this page