Surgical Sheath 20 Fr (Trokamed) – Inflow Speed Risk (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.
Brand
Trokamed GmbH Kleine Breite 17 Geisingen Germany
Lot Codes / Batch Numbers
REF: WA2PS20L, UDI-DI: 04251303810919, Lot Numbers: 154236
Products Sold
REF: WA2PS20L; UDI-DI: 04251303810919; Lot Numbers: 154236
Trokamed GmbH Kleine Breite 17 Geisingen Germany is recalling Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube. due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, PA
Page updated: Jan 10, 2026