BRACKET

SORIN GROUP ITALIA SRL · Model BMR · UDI-DI 08033178113502

KRI Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Recalls

Date	Firm	Reason
2025-06-27	Maquet Cardiopulmonary Gmbh	Device does not comply with the labeling requirements of international standard IEC 60601-1.
2020-06-18	Maquet Cardiovascular Us Sales, Llc	Removal for a specific lot, lot number 70128207, of Holder HKHZ 19 for use with QUADROX iD Pediatric Oxygenator. The Holder may not always snap and securely hold the oxygenator as
2018-04-04	Maquet Cardiopulmonary Ag	There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations.
2011-08-12	Terumo Cardiovascular Systems Corporation	Level Sensor II mounting pads may not stick to the venous reservoir and may detach either at case setup or during a case.
2011-03-01	Terumo Cardiovascular Systems Corp	Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line
2009-12-14	Medtronic Inc	Medtronic has identified a small number of Autotransfusion One Source Kits and MAXPAC/Total System lots with incorrect Use Before Dates (UBD) on the outer kit package label. The U
2009-12-14	Medtronic Inc	Medtronic has identified a small number of Autotransfusion One Source Kits and MAXPAC/Total System lots with incorrect Use Before Dates (UBD) on the outer kit package label. The U
2009-10-02	Terumo Cardiovascular Systems Corporation	Backplate reservoir holders were manufactured with an incorrect configuration of connector supports. The devices were manufactured and configured with two 3/8 inch and one inch co

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data 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.