Bio-Medicus recallZ-0003-2022 · Medtronic Perfusion Systems · initiated Sep 13, 2021
Open, Classified
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 Medtronic Perfusion Systems 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 was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
FDA root cause category: Under Investigation by firm
What the company is doing
The recalling firm issued letters dated September 2021 beginning 9/13/2021 via 2-day UPS delivery to consignees. For outside of the United States, the recall letter will be delivered via regionally-approved methods to consignees who received the product. The letter explains the issue and requests the consignee review their inventory for the affected product. The product is to be immediately quarantined and returned after first contacting Customer Service. A Customer Confirmation Form was enclosed to be returned via email. The letter was to be shared with others within their organization as appropriate and to any other locations who have received the product through a transfer. Consignees are asked to review the Medtronic Urgent Medical Device Recall notification and follow the Recommended Actions, including quarantining and returning all unused affected Bio-Medicus Insertion Kits in their inventory.
Recall details
- Recall number
- Z-0003-2022
- Status
- Open, Classified
- Initiated by the company
- Sep 13, 2021
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 168 kits
- Product code
- DWF
- FDA submissions
- K190557
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of Massachusetts and the countries of Belgium, France, Germany Japan, Korea, Saudi Arabia, Spain, and Turkey.
Product description
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Code information (models, lots, serial numbers)
Model 96553 - Serial number 220719040, GTIN 20763000116006; Model 96551 - Serial number 220641720, GTIN 20763000115986.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Bio-Medicus™ 96551Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall4 reports
- Bio-Medicus™ 96553Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall0 reports
Product lines
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 16, 2026. Text above is shown as published by the FDA.
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