Z-1024-04

Percutaneous Transluminal Coronary Angioplasty system in sterile pouch

Name: Z-1024-04 Percutaneous Transluminal Coronary Angioplasty system in sterile pouch
Creator: Medtronic Vascular
Published: 2004-06-08
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2004-06-08 / Terminated / root cause: sterility

FDA source

Medtronic Vascular began a recall of Percutaneous Transluminal Coronary Angioplasty system in sterile pouch on 2004-06-08. The reason FDA records is "medical device for which sterility may be compromised because of improper seal". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1024-04
Status: Terminated
Initiated: 2004-06-08
Posted: 2004-07-20
Terminated: 2004-11-09
Recalling firm: Medtronic, Inc.
Product: Percutaneous Transluminal Coronary Angioplasty system in sterile pouch.
Product code: LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Reason for recall: medical device for which sterility may be compromised because of improper seal.
Root cause tag: sterility
FDA root cause: Other
Action: A notice letter was sent to all 40 consignees, and phone contact is made. A physical visit to the account would be conducted to collect affected product.
Quantity in commerce: 193 units
Distribution: Product was distributed to 40 hospitals
Product codes and lots: 1) PMA # P790017/S79 2) Device Listing Number 2112641 3) Facility Registration number 2953200 4) lot codes 44DOE015, 44DOE016, 44DOE019, 44DOE022, 44DOE023, 44DOE020, 44DOE024, 44DOE025, 44DOE026, 44DOE021, 44DOE029, 44DOE032 5) Item numbers NCS2506ZP, NCS3016ZP, NCS2511ZP, NCS3516ZP, NCS3511ZP, NCS3521ZP, NCS3006ZP, NCS3011ZP, NCS2516ZP, NCS4006ZP, NCS4011ZP, NCS3021ZP

Product code LOX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)