FDA Medical Device Recalls (openFDA)
Trokamed GmbH: Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.
- Recall number
- Z-0716-2025
- Recalling firm
- Trokamed GmbH
- Product
- Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.
- Status
- Open, Classified
- Initiated
- 2024-11-27
- Posted
- 2025-01-10
- Terminated
- not on file
- Reason
- If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.
- Root cause
- Labeling False and Misleading
- Action
- On November 27, 2024, a "URGENT SAFETY FIELD NOTICE" email was sent to the distributor. Actions to be taken: - Inform the medical personnel using the product about the update of the IFU: 1. The Instructions for Use has to be exchanged. 2. Complete the enclosed acknowledgement of receipt and email to anna.speker@trokamed.de by the provided date. - Please be informed that the assumption of risks is on your behalf when you will not send back the acknowledgement by the provided date. Disclosure of the information described herein: Please ensure in your organization that all users of the above-mentioned products and other persons to be informed are made aware of this Urgent Field Safety Notice. If you have given the products to third parties, please forward a copy of this information or inform the contact person indicated below. Please keep this information at least until the action has been completed. If you have any questions or concerns about this notification, please contact the Quality Management Representative at +49 7704 9244 60. ***Updated 2/5/2025*** On 01/14/2025 an updated "URGENT SAFETY FIELD NOTICE" letter was sent to their distributor account. What measures are to be taken by the recipient? 1. Inform the medical personnel using the product about this field safety notice. 2. Replace your current Instructions for Use for this device with the updated version provided (W9229406_01). This is not a product removal action. You may continue to use the device as per this letter and the updated Instruction for Use. 3. Acknowledge receipt according to the instructions provided by your local distributor. Please ensure in your organization that all users of the above-mentioned products and other persons to be informed are made aware of this Urgent Field Safety Notice. If you have given the products to third parties, please forward a copy of this information or inform the contact person indicated below. Please keep this information at least until the action has been
- Quantity
- 102 units
- Distribution
- US (Domestic) distribution in state of PA and OUS (foreign) to country of Germany. .
- Lot, serial or model codes
- REF: WA2PS18L; UDI-DI: 04251303810872; Lot Numbers: 154214
- 510(k) numbers
- ["K200770"]
- PMA numbers
- not on file
- Product code
- FED
- Firm FEI
- 3004595684
- Firm city
- Geisingen
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28