Flo-Thru Intraluminal Shunt. Used in coronary artery or… recallZ-1019-2022 · Baxter Healthcare Corporation · initiated Apr 1, 2022
Class II Terminated All recalls posted in April 2022
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is a potential for foreign matter.
FDA root cause category: Process control
What the company is doing
An Urgent Medical Device Recall communication was sentt to affected customers via U.S.P.S., first class mail on 04/01/2022. Customers are advised to: 1) Locate and return any unused affected product from your facility. The product code and lot number can be found on the individual product pouch or carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. Please have your Baxter 8-digit ship-to account number, product code, lot number, and quantity of product to be returned ready when calling. 3. Acknowledge receipt of this notification by completing a reply form on the customer portal.
Recall details
- Recall number
- Z-1019-2022
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 1, 2022
- Posted by the FDA
- Apr 29, 2022
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 300 devices
- Product code
- DXC
- FDA submissions
- K981624
- Distribution
- Distribution in the United States including AL, CA, KY, NY, OR, PA, and TX OUS distribution to Japan, Italy, Netherlands, Switzerland, and United Kingdom
Product description
Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis.
Code information (models, lots, serial numbers)
Product Code: FT12150; Lot: SP21J21-1584173
Other devices under the same FDA submission
9 devices cleared under K981624 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Flo-Thru Intraluminal Shunt® FT-12125Synovis Life Technologies, Inc. · CLAMP, VASCULAR1 recall1 report
- Flo-Thru Intraluminal Shunt® FT-12225Synovis Life Technologies, Inc. · CLAMP, VASCULAR1 recall1 report
- Flo-Thru Intraluminal Shunt® FT-12100Synovis Life Technologies, Inc. · CLAMP, VASCULAR1 recall0 reports
- Flo-Thru Intraluminal Shunt® FT-12150Synovis Life Technologies, Inc. · CLAMP, VASCULAR1 recall0 reports
- Flo-Thru Intraluminal Shunt® FT-12175Synovis Life Technologies, Inc. · CLAMP, VASCULAR1 recall0 reports
- Flo-Thru Intraluminal Shunt® FT-12200Synovis Life Technologies, Inc. · CLAMP, VASCULAR1 recall0 reports
- Flo-Thru Intraluminal Shunt® FT-12250Synovis Life Technologies, Inc. · CLAMP, VASCULAR1 recall0 reports
- Flo-Thru Intraluminal Shunt® FT-12275Synovis Life Technologies, Inc. · CLAMP, VASCULAR1 recall0 reports
- Flo-Thru Intraluminal Shunt® FT-12300Synovis Life Technologies, Inc. · CLAMP, VASCULAR1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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