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Terminated

Medtronic AVE Everest PTCA Inflation Catheter 20 cc Item #AC2200

FDA Recall Z-0625-03 · Posted 2003-03-06

Recalling FirmMedtronic, Inc.
Recall StatusTerminated
Product CodeLOX
Date Initiated2003-01-31
Date Terminated2003-05-01
Product Quantity602 units

Reason for Recall

PTCA balloon catheter contains a pressure gauge that does not accurately reflect the pressure of the balloon

Firm Action

Medtronic AVE notified the two distributors in Japan on 1/31/2003 who will notify the sales representative to retrieve product from the hospital accounts.Product will be returned to Danvers, accounted and scrapped.

Root Cause

Other

Distribution Pattern

Japan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K942269MEDTRONIC EVEREST INFLATION DEVICEMedtronics Interventional Vascular · 1994-10-18

Official Source

View FDA Recall →

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

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