NA
BOSTON SCIENTIFIC CORPORATION · Model M0064101010 · UDI-DI 08714729005278
GBO
Prescription
10
510(k) clearances
1,835
Adverse events (15 deaths)
8
Recalls
52
Facilities
Description
Malecot Nephrostomy Catheter Set
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-12-27 | Cook Inc. | Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured to specification, which could lead to leakage from the Mac-Loc hub assembly. |
| 2017-12-12 | Boston Scientific Corporation | Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. |
| 2017-12-12 | Boston Scientific Corporation | Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. |
| 2017-12-12 | Boston Scientific Corporation | Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. |
| 2017-12-12 | Boston Scientific Corporation | Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. |
| 2017-12-12 | Boston Scientific Corporation | Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. |
| 2009-03-18 | Boston Scientific Corporation | Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal |
| 2004-06-25 | Boston Scientific Corp | Mislabeled as to size; 10FR are labeled as 8FR. |
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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.