Z-0816-03

Belos VR - implantable cardioverter defibrillator. Implantable Cardioverter Defibrillators. The Belos VR is a...

Name: Z-0816-03 Belos VR - implantable cardioverter defibrillator. Implantable Cardioverter Defibrillators. The Belos VR is a...
Creator: Biotronik Inc
Published: 2003-03-21
License: https://open.fda.gov/license/

BIOTRONIK AG / initiated 2003-03-21 / Terminated

FDA source

Biotronik Inc began a recall of Belos VR - implantable cardioverter defibrillator. Implantable Cardioverter Defibrillators. The Belos VR is a single-chamber implantable cardioverter... on 2003-03-21. The reason FDA records is "Potential extended charge time anomalies". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0816-03
Status: Terminated
Initiated: 2003-03-21
Posted: 2003-05-14
Terminated: 2004-10-13
Recalling firm: BIOTRONIK AG
Product: Belos VR - implantable cardioverter defibrillator. Implantable Cardioverter Defibrillators. The Belos VR is a single-chamber implantable cardioverter defibrillator (ICD) that detects and treats ventricular tachyarrhythmias and provides rate adaptive bradycardia pacing support. The ICDs are designed to collect diagnostic data to aid the physician''s assessment of a patient''s condition and the performance of the implanted device.
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
Reason for recall: Potential extended charge time anomalies
FDA root cause: Other
Action: The firm issued a letter dated 3/21/03 via certified return receipt requested. The envelope and letter are flagged 'IMPORTANT: Patient Management Information'. The letter recommends that physicians schedule an immediate follow-up visit with each of their patients implanted with an affected Belos VR or VR-T ICD to evaluate the device charge times. The firm provided the doctors with the names of their patients.
Quantity in commerce: 469
Distribution: The firm distributed to physicians throughout the United States. The firm only distributes to US customers.
Product codes and lots: Part number 330444. Serial numbers 78110211, 78110212, 78110215, 78110226, 78110227, 78110229, 78110231, 78110233, 78110234, 78110235, 78110270, 78110287, 78110288, 78110290, 78110292, 78110294, 78110295, 78110296, 78110297, 78110298, 78110299, 78110300, 78110302, 78110303, 78110305, 78110306, 78110307, 78110308, 78110309, 78110310, 78110315, 78110316, 78110318, 78110325, 78110331, 78110335, 78110336, 78110337, 78110339, 78110340, 78110341, 78110342, 78110344, 78110345, 78110347, 78110348, 78110349, 78110351, 78110352, 78110361, 78110362, 78110363, 78110364, 78110365, 78110376, 78110378, 78110380, 78110387, 78110388, 78110390, 78110401, 78110402, 78110403, 78110404, 78110405, 78110406, 78110407, 78110408, 78110411, 78110412, 78110413, 78110414, 78110416, 78110417, 78110418, 78110420, 78110421, 78110454, 78110455, 78110457, 78110459, 78110461, 78110462, 78110463, 78110464, 78110465, 78110466, 78110467, 78110468, 78110469, 78110470, 78110471, 78110472, 78110477, 78110479, 78110483, 78110484, 78110485, 78110486, 78110487, 78110488, 78110494, 78110496, 78110497, 78110501, 78110504, 78110505, 78110507, 78110510, 78110511, 78110512, 78110513, 78110520, 78110525, 78110526, 78110530, 78110535, 78110536, 78110537, 78110538, 78110539, 78110540, 78110541, 78110542, 78110544, 78110545, 78110546, 78110547, 78110550, 78110551, 78110559, 78110561, 78110565, 78110566, 78110568, 78110569, 78110571, 78110572, 78110574, 78110575, 78110576, 78110577, 78110579, 78110585, 78110587, 78110588, 78110589, 78110592, 78110595, 78110596, 78110597, 78110598, 78110599, 78110600, 78110601, 78110602, 78110603, 78110604, 78110605, 78110606, 78110608, 78110609, 78110611, 78110612, 78110614, 78110621, 78110627, 78110628, 78110629, 78110632, 78110633, 78110634, 78110636, 78110639, 78110641, 78110642, 78110643, 78110650, 78110651, 78110658, 78110690, 78110691, 78110692, 78110694, 78110704, 78110705, 78110706, 78110766, 78110773, 78110786, 78110789, 78110791, 78110793, 78110795, 78110799, 78110800, 78110811, 78110814, 78110815, 78110823, 78110824, 78110827, 78110828, 78110833, 78110835, 78110838, 78110843, 78110844, 78110845, 78110856, 78110857, 78110865, 78110866, 78110867, 78110870, 78110872, 78110875, 78110876, 78110877, 78110878, 78110879, 78110880, 78110881, 78110882, 78110883, 78110884, 78110885, 78110897, 78110905, 78110906, 78110907, 78111001, 78111002, 78111003, 78111005, 78111006, 78111021, 78111022, 78111023, 78111024, 78111025, 78111071, 78111076, 78111079, 78111080, 78111091, 78111092, 78111096, 78111097, 78111142, 78111148, 78111150, 78111155, 78111162, 78111171, 78111181, 78111201, 78111203, 78111206, 78111207, 78111208, 78111210, 78111220, 78111231, 78111239, 78111257, 78111259, 78111260, 78111261, 78111270, 78111276, 78111277, 78111278, 78111279, 78111280, 78111281, 78111282, 78111283, 78111290, 78111294, 78111296, 78111297, 78111313, 78111316, 78111327, 78111328, 78111330, 78111331, 78111333, 78111334, 78111335, 78111336, 78111337, 78111339, 78111340, 78111341, 78111343, 78111345, 78111351, 78111353, 78111361, 78111362, 78111406, 78111409, 78111430, 78111439, 78111440, 78111444, 78111447, 78111448, 78111449, 78111496, 78111498, 78111502, 78111517, 78111519, 78111520, 78111522, 78111594, 78111655, 78111666, 78111667, 78111668, 78111669, 78111802, 78111828, 78111832, 78111839, 78111840, 78111841, 78111843, 78111844, 78111845, 78111846, 78111888, 78111900, 78111901, 78111902, 78111909, 78111911, 78111912, 78111913, 78111914, 78111915, 78111917, 78111918, 78111924, 78111961, 78111979, 78111980, 78111982, 78111985, 78111993, 78111994, 78111995, 78111996, 78111997, 78111998, 78112018, 78112029, 78112045, 78112046, 78112100, 78112105, 78112111, 78112112, 78112113, 78112114, 78112116, 78112117, 78112120, 78112149, 78112150, 78112151, 78112158, 78112162, 78112163, 78112178, 78112180, 78112182, 78112201, 78112211, 78112225, 78112226, 78112235, 78112244, 78112258, 78112259, 78112260, 78112261, 78112267, 78112285, 78112294, 78112295, 78112296, 78112297, 78112300, 78112302, 78112303, 78112310, 78112312, 78112314, 78112315, 78112316, 78112317, 78112318, 78112319, 78112321, 78112322, 78112323, 78112324, 78112325, 78112327, 78112338, 78112339, 78112345, 78112346, 78112349, 78112350, 78112360, 78112361, 78112362, 78112377, 78112381, 78112384, 78112387, 78112388, 78112389, 78112392, 78112446, 78112477, 78112478, 78112493, 78112494, 78112495, 78112496, 78112497, 78112500, 78112503, 78112504, 78112506, 78112507, 78112508, 78112509, 78112549, 78112550, 78112552, 78112554, 78112555, 78112556, 78112557, 78112613, 78112614, 78112615, 78112617, 78112618, 78112619, 78112620, 78112621, 78112622, 78112623, 78112624, 78112644, 78112645, 78112647, 78112648, 78112676, 78112831, 78112835

Product code LWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)