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QUART
Maquet Cardiopulmonary AG · Model BEQ-HBF 140 Arterial Filter, Sterile · UDI-DI 04037691173412
DTM
Prescription
1
510(k) clearances
261
Adverse events (7 deaths)
5
Recalls
26
Facilities
Description
QUART Arterial Filter with BIOLINE Coating, Sterile. The QUART arterial filter (HBF 140) is a screen filter with integrated bypass and pre-postdeairing mechanic. It is used for removing gaseous embolisms and aggregates from blood components of the arterial bloodline during extracorporeal circulation. Therefore utilization of the arterial filter reduces the patient’s risk of injury from a micro embolism caused by gases or solids.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-11-14 | Medtronic Perfusion Systems | Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port. |
| 2013-07-26 | Terumo Cardiovascular Systems Corporation | Medical device used in cardiovascular procedures is defective. |
| 2013-06-14 | Medtronic Inc. Cardiac Rhythm Disease Management | 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 |
| 2008-05-09 | Medtronic Perfusion Systems | Medtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with c |
| 2005-10-06 | Cobe Cardiovascular, Inc | One way valve in the heart lung pack assembly may be missing. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.