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INSPIRE
SORIN GROUP ITALIA SRL · Model 7F M · UDI-DI 08033178113342
1
510(k) clearances
261
Adverse events (7 deaths)
5
Recalls
26
Facilities
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.