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M-Drain
Mermaid Medical A/S · Model D12008025 · UDI-DI 15711055001066
FGE
Prescription
10
510(k) clearances
33,832
Adverse events (359 deaths)
451
Recalls
148
Facilities
Description
The Percutaneous Drainage Catheter with hydrophilic coating is used for drainage of abscess and fluid collections. The catheter is made from a soft, biocompatible plastic, a material which is radiopaque for X-rays. The distal end of catheter contains a “J” or a self-retaining pigtail and drainage holes.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-19 | Olympus Corporation of the Americas | Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm, |
| 2026-05-22 | W L Gore & Associates, Inc. | 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010). |
| 2026-05-22 | W L Gore & Associates, Inc. | 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010). |
| 2026-05-21 | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. |
| 2026-05-21 | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. |
| 2026-05-21 | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. |
| 2026-05-21 | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. |
| 2026-05-21 | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. |
| 2026-05-21 | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. |
| 2026-03-05 | Cook Incorporated | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
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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.