Z-0159-2007

Jostra HL-20 Heart Lung Machine - guiding pins

Name: Z-0159-2007 Jostra HL-20 Heart Lung Machine - guiding pins
Creator: MAQUET Inc.
Published: 2006-10-03
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2006-10-03 / Terminated

FDA source

MAQUET Inc. began a recall of Jostra HL-20 Heart Lung Machine - guiding pins on 2006-10-03. The reason FDA records is "The HL-20's pump head on the roller pump has four pairs of tube guide rolls that keep the tube in place in the raceway and roll along the inserted tube as the pump head turns. If dirt and other particles accumulate in...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0159-2007
Status: Terminated
Initiated: 2006-10-03
Posted: 2006-11-07
Terminated: 2007-12-19
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Jostra HL-20 Heart Lung Machine - guiding pins
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: The HL-20's pump head on the roller pump has four pairs of tube guide rolls that keep the tube in place in the raceway and roll along the inserted tube as the pump head turns. If dirt and other particles accumulate in the tube guide rolls, they cannot roll smoothly and finally they can get stuck.
FDA root cause: Other
Action: An 'Important Safety Notice - Please Read Immediately' letter was sent to all US customers on 10/3/06 by FedEx Return Receipt.
Quantity in commerce: 227 HL-20 base units with 545 single pumps
Distribution: Worldwide
Product codes and lots: All HL 20 systems Serial #s 1159,14031794,14031795, 14031796,14031797,14031798, 100155, 1345, 1363,1588, 14031765, 14031766, 1570, 1571,1593,1319,1320,1321,1322,14031774,14031775, 14031776, 1323,1324,1478,1479,14031067,14031069,10331385,1597,14021730,14031792,1459,1701,1512,1513,100035, 100036, 1034,1035, 14031045, 14031046, 14031047, 14031048, 1022,1023,1541,1559,100094,1025,1026,1032,1331,1332, 100011,100015,100016,100009,100063, 1668,1511, 1652, 1702,1454,1455, 1379,1380, 1381, 1272, 1417,1480, 1500, 1653, 14031054, 14031055,14031059, 14041074, 14041874, 1128, 1592, 100030, 100031, 100012, 100013, 1595, 1596, 14031039, 1510, 1105, 1433, 1434, 1456, 1457, 1577, 1578, 1579, 14021718, 14021719, 14041904, 100026, 14021706, 1420, 1421, 1398, 1418, 1598, J14041874,1584, 100108, 100109,14041074, JOSTRA, 1132, 100009, 100010,100130,100131, 1625, 1626, 1627, 1628, 1629, 100135, 100136, 100137, 1199, 1200, 1540, 1552, 1567, 1568, 1569, 1580, 1581, 1584, 1585, 1586, 14031040, 14031068, 14031761, 14031762, 1716, 100084, 14021716, 14041882, 100188, 1562, 1563, 100028, 100023, 14031831, 14031793, 1019, 1020, 1021, 1295, 100021, 100022, 14031777, 14031778, 14031779, 1523, 1524, 1017, 1442, 1443, 1465, 1466, 1635, 100116, 14031051, 14031052, 1507, 1508, 1509, 14031732, 100001, 100002, 100061, 100062, 14031734, 14031735, 14031736, 100017, 1483, 1481, 1482, 14031056, 14031057, 1535,1536, 1537, 1538, 1539, 1547, 1548, 1549, 1550, 1551, 14031060, 14031061, 14031062, 14031063, 100219,100220, 100221, 100222, 100223, 100224, 100225, 100226, 100227, 100228, 1642, 1643, 1494, 1666, 1667, 1618, 1619, 1517, 1518, 100027, 1345

Product code DTQ

K943803Class IIJostra Hl-20 Integrated Perfusion SystemJanus Biomedical, Inc. / cleared 1996-01-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)