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Vascular Medical Disposable Inflation Device

ATRION MEDICAL PRODUCTS, INC. · Model QL2030PR · UDI-DI 00856877002452

KOE MAV Prescription

510(k) clearances

221

Adverse events

Recalls

Facilities

Description

Inflation Device: 20mL, 30atm

Recalls

Date	Firm	Reason
2019-01-04	Cook Inc.	The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
2019-01-04	Cook Inc.	The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
2005-08-01	Cook Urological, Inc.	Mislabeled as to size.

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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.