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EnSite™
ST. JUDE MEDICAL, INC. · Model EC1000 · UDI-DI 05414734215664
MTD
Prescription
1
510(k) clearances
1,862
Adverse events (30 deaths)
9
Recalls
31
Facilities
Description
Multi-electrode Diagnostic Catheter
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-04-28 | Abbott | Incorrect product labeling. |
| 2020-04-22 | BIOSENSE WEBSTER | Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map. |
| 2017-05-17 | Biosense Webster, Inc. | Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves. |
| 2017-05-17 | Biosense Webster, Inc. | Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves. |
| 2016-04-14 | Biosense Webster, Inc. | Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this catheter relative to p |
| 2016-04-14 | Biosense Webster, Inc. | Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this catheter relative to p |
| 2015-08-12 | Abbott Electrophysiology | The expiration date was incorrectly printed on the pouch/box labels of 19 products that were shipped to customer sites. The manufacturing date was accidentally used (copied) for th |
| 2014-02-20 | Biosense Webster, Inc. | Biosense Webster is recalling the PentaRay Nav Catheter because it has the potential to have partial tip separation from the catheter shaft. Biosense Webster is expanding the reca |
| 2005-02-14 | Boston Scientific | The coating on the product's surface can generate debris, which could then move from the heart towards the brain, resulting in Ischemic events. |
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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.