Biosense Webster Recalls 20-Pole Eco Cable Due to Calibration Error
Biosense Webster is recalling 54 units of the 20-Pole Eco Cable because incorrect calibration prevents the connected catheter from being recognized by the system.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a functional failure (catheter not recognized) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biosense Webster, Inc. is recalling 54 units of the 20-Pole Eco Cable (Catalog #EM-5050-060). The product is an interface cable intended to connect the LASSO NAV Eco Catheter to the CARTO 3 System. The recall is due to the cable being incorrectly calibrated.
When a catheter is connected to an affected 20-Pole Eco Cable, the catheter will not be recognized by the system. The recall covers 54 units distributed worldwide, including the United States and specific international locations such as DE, NL, CH, FR, GB, and DK.
Healthcare facilities should identify affected units by checking the serial numbers and lot numbers listed in the recall notice. Affected serial numbers include 120, 132, 134, 136, 151, 342, 350, 354, 356, 363, 368, 373, 379, 380, 384, 385, 402, 405, 424, 919, 953, 954, 960, 963, 968, 970, 977, 980, 993, 998, 1001, 1123, 1148, 1378, 1596, 1729, 1745, 1747, 1749, 1750, 1751, 1753, 1754, 1758, 1759, 1760, 1761, 1797, 1799, 1802, 1803, 1804, and 1805. Affected lot numbers are P1210, P1220, P1221, and P1231. Users should stop using affected cables and contact the manufacturer for instructions.
The recalled product
- Product
- 20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System.
- Manufacturer
- Biosense Webster, Inc.
- Affected units
- 54
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Impacted serial Numbers: 120
- 132
- 134
- 136
- 151
- 342
- 350
- 354
- 356
- 363
- 368
- 373
- 379
- 380
- 384
- 385
- 402
- 405
- 424
- 919
Distribution
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