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vanSonnenberg™ Sump
BOSTON SCIENTIFIC CORPORATION · Model M001273000 · UDI-DI 08714729137733
FFA
Prescription
3
510(k) clearances
677
Adverse events (5 deaths)
10
Recalls
7
Facilities
Description
Sump Catheter System
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-07-18 | Boston Scientific Corporation | There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility. |
| 2024-07-18 | Boston Scientific Corporation | There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility. |
| 2024-07-18 | Boston Scientific Corporation | There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility. |
| 2024-07-18 | Boston Scientific Corporation | There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility. |
| 2024-07-18 | Boston Scientific Corporation | There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility. |
| 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 |
| 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 |
| 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 |
| 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 |
| 2006-09-21 | Boston Scientific Corp | Sterility compromised/package integrity : the bottom of the Tyvek pouch may not have been sealed. |
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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.