Z-0625-03

Medtronic AVE Everest PTCA Inflation Catheter 20 cc Item #AC2200

Name: Z-0625-03 Medtronic AVE Everest PTCA Inflation Catheter 20 cc Item #AC2200
Creator: Medtronic, Inc.
Published: 2003-01-31
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2003-01-31 / Terminated

FDA source

Medtronic, Inc. began a recall of Medtronic AVE Everest PTCA Inflation Catheter 20 cc Item #AC2200 on 2003-01-31. The reason FDA records is "PTCA balloon catheter contains a pressure gauge that does not accurately reflect the pressure of the balloon". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0625-03
Status: Terminated
Initiated: 2003-01-31
Posted: 2003-03-06
Terminated: 2003-05-01
Recalling firm: Medtronic, Inc.
Product: Medtronic AVE Everest PTCA Inflation Catheter 20 cc Item #AC2200
Product code: LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Reason for recall: PTCA balloon catheter contains a pressure gauge that does not accurately reflect the pressure of the balloon
FDA root cause: Other
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.
Quantity in commerce: 602 units
Distribution: Japan
Product codes and lots: Lot Numbers: 122851, 12852, 122853

Product code LOX

K942269Class IIMedtronic Everest Inflation DeviceMedtronics Interventional Vascular / cleared 1994-10-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)