Affinity recallZ-0693-2020 · Medtronic Perfusion Systems · initiated Nov 14, 2019
Terminated
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
Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.
FDA root cause category: Process control
What the company is doing
Beginning 14-Nov-2019, Medtronic initiated an immediate Urgent Medical Device Recall via verbal communication to one (1) customer that was shipped the affected product according to Medtronic records. The customer was asked to identify and quarantine any unused affected product. The immediate communication was followed by a written urgent medical device recall notification beginning on 26-Nov-2019 to communicate the issue to the one (1) customer that received affected product. The consignee was asked to confirm receipt of urgent medical device recall notification via a Customer Confirmation Certificate. Medtronic is seeking the return of the affected product.
Recall details
- Recall number
- Z-0693-2020
- Status
- Terminated
- Initiated by the company
- Nov 14, 2019
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 24 units
- Product code
- DTM
- FDA submissions
- K952532
- Distribution
- CA
Product description
Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
Code information (models, lots, serial numbers)
UDI 20643169858835, Lot Numbers: 13316512
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Affinity™ 61399401124Medtronic, Inc. · Filter, blood, cardiopulmonary bypass, arterial line1 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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