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Woven
BOSTON SCIENTIFIC CORPORATION · Model M0045FMC001210 · UDI-DI 08714729901020
DRF
Prescription
10
510(k) clearances
8,756
Adverse events (307 deaths)
26
Recalls
88
Facilities
Description
Diagnostic Electrode Catheter
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-08-24 | Irvine Biomedical Inc, a St. Jude Medical Co. | Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model IBI-87002, batch 7397307. Packages labeled Model IBI-87002, batch 7397307 |
| 2020-08-24 | Irvine Biomedical Inc, a St. Jude Medical Co. | Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model IBI-87002, batch 7397307. Packages labeled Model IBI-87002, batch 7397307 |
| 2018-07-30 | Arrow International Inc | Products are labeled with an incorrect expiration date |
| 2015-09-29 | Medtronic Inc. | 64 units of Achieve Electrical Cables were shipped with a potential sterility breach. |
| 2015-04-17 | Biosense Webster, Inc. | The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation System. |
| 2015-02-25 | Biosense Webster, Inc. | Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover. |
| 2014-11-20 | Boston Scientific Corp | Some IntellaMap Orion High Resolution Mapping Catheters are exhibiting a failure mode in which a glue bond on the Deployment Interlock Button has been observed to fail in the field |
| 2014-10-14 | St Jude Medical | St. Jude Medical is performing a voluntary recall of batch 4671318, model number 401353 of the Response Fixed Curve DECA 6F 65cm CSL 2/8 Catheter. Specifically, the firm has identi |
| 2013-06-19 | Biosense Webster, Inc. | Biosense Webster is recalling the 20-Pole LASSO NAV Catheter Eco because it has been incorrectly calibrated causing them to be recognized and displayed as a 10-Pole LASSO NAV Cathe |
| 2011-05-23 | Biosense Webster, Inc. | The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes catheters with Auto ID Technology are not being recognized when connected to th |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.