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M-Drain

Mermaid Medical A/S · Model D12007035 · UDI-DI 15711055001035

FGE Prescription

510(k) clearances

33,832

Adverse events (359 deaths)

450

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
2026-05-22	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.
2025-08-28	Boston Scientific Corporation	The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.

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Data 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.