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Terminated

Guidant Brand VasoView 5 Harvesting Cannula System, Model Number: VH-1000

FDA Recall Z-0292-04 · Posted 2004-07-20

Recalling FirmGuidant Cardiac Surgery
Recall StatusTerminated
Product CodeHET
Date Initiated2003-11-19
Date Terminated2004-03-09
Product Quantity2597 units

Reason for Recall

VasoView 5 scissors are stiff and/or the scissor toggle has the potential to break during use.

Firm Action

On 11/19/03, the firm issued letters via FedEx to all its direct consignees, informing them of the affected devices and providing instructions on the recall.

Root Cause

Nonconforming Material/Component

Distribution Pattern

There are a total of 130 consignees that received the recalled product distributed by Guidant. The firm has identified 0 (zero) wholesaler dealers, 7 distributors or affiliate companies, 0 (zero) retailers and 123 hospitals that received the recalled product distributed by Guidant. The recalled product was distributed in the United States and internationally. Recalled product was distributed by the firm to one (1) government account: USAF Medical Center Keesler, 1301 I Street, Keesler Air Force Base, MS 39534, (228) 377-2778. International countries include: Puerto Rico, Belgium, Chile, France, Germany, Italy and Kuwait.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020143VASOVIEW 5 HARVESTING CANNULAGuidant Corporation, Cardiac Surgery · 2002-02-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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