Filter, Blood, Cardiopulmonary Bypass, Arterial Line
FDA adverse event reports and recall history for filter, blood, cardiopulmonary bypass, arterial line (product code DTM), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 261
- Deaths
- 7
- Injuries
- 38
- Malfunctions
- 197
Reports per year
Source: FDA adverse event reports by year received, 2010–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2013-09-20TerminatedNonconforming Material/Component
Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation, packaged as part of a Terumo Cardiovascular Procedure Kit or as a single, sterile filter unit Single/Sterile Terumo Pall AL6X Arterial Filter: The Terumo Pall AL6X Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of micro-emboli greater than 40 microns in size, including gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris from the arterial line and where the flow rate will not exceed 8 liters per minute. Cardiovascular Procedure (Convenience) Kit that includes the Terumo Pall AL6X Arterial Filter: The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed. The sterile cardiovascular procedure kit is intended to be used one time for periods up to 6 hours.
Medical device used in cardiovascular procedures is defective.
- 2013-08-14TerminatedEmployee error
Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylene oxide. Recall Update 9/6/13: Medtronic, Red cross Infant Pack 1/B, South-Africa, REF M272403C, Sterile EO. The Affinity Pediatric Arterial Filters are single-use, sterile, nonpyrogenic devices designed to filter microemboli greater than the specified micron size from the circuit for periods up to 6 hours during cardiopulmonary bypass surgery. These devices are available both in an uncoated and a Carmeda coated option. The Carmeda coating is a BioActive surface that is non-leaching and provides a thromboresistant blood contact surface.
Medtronic is recalling 148 Affinity Pediatric Arterial Filters from 2 manufacturing lots because a limited quantity of filters may have a small breach in the filter media that may allow unwanted particulate or gaseous emboli to pass through the filter and the outlet of the device, which could result in serious injury to a pediatric patient including neurological damage, or potential patient death.
- 2008-07-24TerminatedNonconforming Material/Component
Medtronic Affinity Pediatric arterial Filter, Arterial Line Filter for Cardiopulmonary Bypass. Catalog Number: CB4014
Medtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with contaminated heparin. Medtronic's heparin supplier recently reported that it had provided some batches to Medtronic that were contaminated with oversulfated chondroitin sulfate (OSCS).
- 2005-12-02TerminatedOther
Custom heart lung perfusion packs
One way valve in the heart lung pack assembly may be missing.
- TerminatedProcess control
Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.
Monitor filter, blood, cardiopulmonary bypass, arterial line automatically
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