Affinity™ 61399401124Recalls & reported problems
Medtronic, Inc. · FILTER 61399401124 AFFINITY 6PK ART 351 · Class 2
All models of Affinity (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- Nov 14, 2019Terminated
Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.
Z-0693-2020 · Root cause: Process control · Recall details · FDA record ↗
Other Filter, blood, cardiopulmonary bypass, arterial line devices
- QUADROX-i HMO 70000-USA #SQUADROX-i Adult o.FilterMaquet Cardiopulmonary AG · Filter, blood, cardiopulmonary bypass, arterial line2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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