BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Enforcement
- Recall Number
- Z-2181-2026
- Event ID
- 98708
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Stryker Sustainability Solutions
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- May 20, 2026
- Initiation Date
- April 10, 2026
- Classification Date
- May 13, 2026
- Address
- 1810 W Drake Dr, Tempe, AZ, 85283-4327, United States
Description
BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
UDI 00885825003838, Lot Numbers: 4225215, 4653836, 4793147, 4852429, 4986000, 5023873, 5043553, 4280561, 4672798, 4799184, 4852603, 4986001, 5023874, 5043556, 4287896, 4677462, 4799186, 4854910, 4986002, 5023875, 5043560, 4296580, 4677463, 4799187, 4856657, 4997834, 5023876, 5053722, 4309622, 4693434, 4799188, 4860078, 5003556, 5027296, 5059498, 4309623, 4693435, 4799191, 4860082, 5003557, 5027297, 5059499, 4309846, 4693436, 4799309, 4861298, 5003558, 5027301, 5064680, 4374217, 4693437, 4800061, 4861536, 5003569, 5027406, 5064916, 4396650, 4728693, 4800062, 4939136, 5004167, 5027407, 5071434, 4458557, 4728695, 4800113, 4953662, 5004181, 5027571, 5072250, 4479919, 4733707, 4801993, 4953663, 5007874, 5028963, 5073207, 4497169, 4755043, 4801994, 4963413, 5009259, 5030330, 5073552, 4507933, 4755045, 4807495, 4963414, 5013933, 5031863, 5083312, 4510607, 4755046, 4808706, 4963418, 5013934, 5032745, 5083313, 4551972, 4755047, 4808707, 4966281, 5013949, 5038102, 5084295, 4566389, 4762910, 4809527, 4968920, 5013956, 5038314, 5085197, 4585687, 4773741, 4811620, 4968921, 5016583, 5038317, 4600586, 4777739, 4811622, 4974743, 5016616, 5038318, 4613364, 4786928, 4811625, 4976214, 5018038, 5038321, 4613429, 4786931, 4829506, 4976215, 5018718, 5038782, 4614815, 4793146, 4829507, 4985998, 5020889, 5043552.
US Nationwide and the countries of Israel and Canada.
217 units