Defibrillators - Recall List by Manufacturer/ Model |
10/4/2005 |
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Manufacturer |
Product Group |
Model |
Limitations |
Recall Date |
Recall Class |
Description |
GUIDANT |
Insignia (pacemaker) - Entra (SSI, DDD, SR, DE), Ultra (SR, DR), Plus (SR, DR), AVT (SSI, VDD, DDD, SR, DR) |
0484, 0485, 0985, 0986, 1195, 1198, 1294, 1295, 1296, 1190, 1290, 1291, 1194, 1297, 1298, 482, 882, 982, 1192, 1292 |
Shipped before March 12, 2004 |
22-Sep-05 |
|
Intermittent or permanent loss of pacing output without warning. The Intermittent or premanent loss of telemetry. Reversion to VVI mode or appearnance of a reset warning message upon interrogation. - Root cause of the first failure mode has been identified as foreign material within a crystal timing component. Supplier has eliminated foreign material within the crystal chamber in devices shipped after March 12, 2004. Second failure mode specific root cause has not yet been determined. |
GUIDANT |
Nexus (pacemaker) Entra (SSI, DDD, SR, Dr), Ultra (SR, DR), Plus (SR, DR) AVT (SSI, VDD, DDD, SR, DR) |
1325, 1326, 1425, 1426, 1395, 1398, 1466, 1494, 1495, 1390, 1490, 1491, 1394, 1467, 1468, 1328, 1428, 1432, 1392, 1492 |
Shipped before March 12, 2004 |
22-Sep-05 |
|
Intermittent or permanent loss of pacing output without warning. The Intermittent or premanent loss of telemetry. Reversion to VVI mode or appearnance of a reset warning message upon interrogation. - Root cause of the first failure mode has been identified as foreign material within a crystal timing component. Supplier has eliminated foreign material within the crystal chamber in devices shipped after March 12, 2004. Second failure mode specific root cause has not yet been determined. |
GUIDANT |
Pulsar |
0470,0870,0970, 0972, 1172, 1272 |
Mfg between 11/25/1997 and 10/26/2000 |
18-Jul-05 |
|
Hermetic sealing component used in devices may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemaker case late in the device service life. This can result in loss of pacing output or sustained Maximum Sensor Rate output. Recommending MDs evaluate for replacement. |
GUIDANT |
Pulsar Max |
1170, 1171, 1270 |
Mfg between 11/25/1997 and 10/26/2000 |
18-Jul-05 |
|
Hermetic sealing component used in devices may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemaker case late in the device service life. This can result in loss of pacing output or sustained Maximum Sensor Rate output. Recommending MDs evaluate for replacement. |
GUIDANT |
Pulsar MAX II |
1180, 1181, 1280 |
Mfg between 11/25/1997 and 10/26/2000 |
18-Jul-05 |
|
Hermetic sealing component used in devices may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemaker case late in the device service life. This can result in loss of pacing output or sustained Maximum Sensor Rate output. Recommending MDs evaluate for replacement. |
GUIDANT |
Discovery |
1174, 1175, 1273, 1274, 1275 |
Mfg between 11/25/1997 and 10/26/2000 |
18-Jul-05 |
|
Hermetic sealing component used in devices may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemaker case late in the device service life. This can result in loss of pacing output or sustained Maximum Sensor Rate output. Recommending MDs evaluate for replacement. |
GUIDANT |
Discovery II |
0481, 0981, 1184, 1186, 1187, 1283, 1284, 1285, 1286 |
Mfg between 11/25/1997 and 10/26/2000 |
18-Jul-05 |
|
Hermetic sealing component used in devices may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemaker case late in the device service life. This can result in loss of pacing output or sustained Maximum Sensor Rate output. Recommending MDs evaluate for replacement. |
GUIDANT |
Meridian |
0476, 0976, 1176, 1276 |
Mfg between 11/25/1997 and 10/26/2000 |
18-Jul-05 |
|
Hermetic sealing component used in devices may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemaker case late in the device service life. This can result in loss of pacing output or sustained Maximum Sensor Rate output. Recommending MDs evaluate for replacement. |
GUIDANT |
Contak TR |
1241 |
Mfg between 11/25/1997 and 10/26/2000 |
18-Jul-05 |
|
Hermetic sealing component used in devices may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemaker case late in the device service life. This can result in loss of pacing output or sustained Maximum Sensor Rate output. Recommending MDs evaluate for replacement. |
GUIDANT |
VIRTUS PLUS II |
1380, 1480 |
Mfg between 11/25/1997 and 10/26/2000 |
18-Jul-05 |
|
Hermetic sealing component used in devices may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemaker case late in the device service life. This can result in loss of pacing output or sustained Maximum Sensor Rate output. Recommending MDs evaluate for replacement. |
GUIDANT |
INTELIS II |
1483, 1484, 1485, 1384, 1385, 1349, 1499 |
Mfg between 11/25/1997 and 10/26/2000 |
18-Jul-05 |
|
Hermetic sealing component used in devices may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemaker case late in the device service life. This can result in loss of pacing output or sustained Maximum Sensor Rate output. Recommending MDs evaluate for replacement. |
GUIDANT |
Renewal 3 AVT Renewal 4 AVT additional |
All |
|
24-Jun-05 |
II |
Subject to component failure which may limit therapy. A magnetic switch in these devices may become stuck in the closed position which limits device ability to treat tachyarrhythmias (fast heart rate) and accelerated battery depletion. Audible tones signal closed switch - Pt should go to Dr/ Hospital immediately. |
GUIDANT |
Prizm 2 DR |
Model 1861 (1860?) |
Manufactured on or before April 16, 2002 |
24-Jun-05 |
I |
Intermal short circuit when attempting to deliver shock, caused by deterioration of electrical insulation and can only be dected after the device has already malfunctioned. |
GUIDANT |
Contak Renewal Contak Renewal 2 |
Model H135 Model H155 |
Manufactured on or before August 26, 2004 |
24-Jun-05 |
I |
Intermal short circuit when attempting to deliver shock, caused by deterioration of electrical insulation and can only be dected after the device has already malfunctioned. |
GUIDANT |
Ventak Prizm AVT |
1900 |
|
24-Jun-05 |
II |
Memory error, which, in rare cases may limit availablilty of therapy. - Mfg expects a non-invasive software solution by year end 2005. |
GUIDANT |
Vitality AVT |
A135, A155 |
|
24-Jun-05 |
II |
Memory error, which, in rare cases may limit availablilty of therapy. - Mfg expects a non-invasive software solution by year end 2005. |
GUIDANT |
Renewal RF |
H230, H235, H239 |
|
24-Jun-05 |
II |
Subject to component failure which may limit therapy. A magnetic switch in these devices may become stuck in the closed position which limits device ability to treat tachyarrhythmias (fast heart rate) and accelerated battery depletion. Audible tones signal closed switch - Pt should go to Dr/ Hospital immediately. |
GUIDANT |
Renewal AVT |
All |
|
17-Jun-05 |
II |
Memory error, which, in rare cases may limit availablilty of therapy. - Mfg expects a non-invasive software solution by year end 2005. |
GUIDANT |
Contak Renewal 3 Contak Renwal 4 |
H170, H173, H175, H177, H179, H190, H195, H197, H199 |
|
17-Jun-05 |
II |
Subject to component failure which may limit therapy. A magnetic switch in these devices may become stuck in the closed position which limits device ability to treat tachyarrhythmias (fast heart rate) and accelerated battery depletion. Audible tones signal closed switch - Pt should go to Dr/ Hospital immediately. |
GUIDANT |
Renewal 3 AVT Renewal 4 AVT |
M150, M155, M157, M159, M170, M175, M77, M179 |
|
17-Jun-05 |
II |
Subject to component failure which may limit therapy. A magnetic switch in these devices may become stuck in the closed position which limits device ability to treat tachyarrhythmias (fast heart rate) and accelerated battery depletion. Audible tones signal closed switch - Pt should go to Dr/ Hospital immediately. |
MEDTRONIC |
Marquis VR |
7230 |
Batteries Mfg before December 2003 |
10-Feb-05 |
|
|
MEDTRONIC |
Marquis DR |
7274 |
Batteries Mfg before December 2003 |
10-Feb-05 |
|
|
MEDTRONIC |
Maximo VR |
7232 |
Batteries Mfg before December 2003 |
10-Feb-05 |
|
|
MEDTRONIC |
Maximo DR |
7278 |
Batteries Mfg before December 2003 |
10-Feb-05 |
|
|
MEDTRONIC |
InSync Marquis |
7277 |
Batteries Mfg before December 2003 |
10-Feb-05 |
|
|
MEDTRONIC |
InSync II Marquis |
7289 |
Batteries Mfg before December 2003 |
10-Feb-05 |
|
|
MEDTRONIC |
InSync III Marquis |
7279 |
Batteries Mfg before December 2003 |
10-Feb-05 |
|
|
MEDTRONIC |
InSync III Protect |
7285 |
Batteries Mfg before December 2003 |
10-Feb-05 |
|
|
MEDTRONIC |
Micro Jewell II |
7223Cx |
|
16-Apr-04 |
II |
No longer on the market. Most were implanted in 1997 - 1998. Problem is longer than normal charge times prior to delivering therapy. |
MEDTRONIC |
GEM DR |
7271 |
|
16-Apr-04 |
II |
Limited distribution. Most were implanted in 1997 - 1998. Problem is longer than normal charge times prior to delivering therapy. |
ST JUDE |
Atlas |
|
|
20-Jun-05 |
II |
Device could fail to recharge between cycles in attempts to deliver multiple shocks in rapid succession. Delay could cause failure to deliver the maximum number of shocks for a given incident. Device could also generate an "electrical noise" which may cause a temporary increase in the pacing rate. Both conditions are correctable with a non-invasive programing change. |
ST JUDE |
EPIC |
|
|
17-Jun-05 |
II |
Device could fail to recharge between cycles in attempts to deliver multiple shocks in rapid succession. Delay could cause failure to deliver the maximum number of shocks for a given incident. Device could also generate an "electrical noise" which may cause a temporary increase in the pacing rate. Both conditions are correctable with a non-invasive programing change. |