FDA Medical Device Recalls (openFDA)
Medtronic Vascular: Percutaneous Transluminal Coronary Angioplasty system in sterile pouch.
- Recall number
- Z-1024-04
- Recalling firm
- Medtronic Vascular
- Product
- Percutaneous Transluminal Coronary Angioplasty system in sterile pouch.
- Status
- Terminated
- Initiated
- 2004-06-08
- Posted
- 2004-07-20
- Terminated
- 2004-11-09
- Reason
- medical device for which sterility may be compromised because of improper seal.
- 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
- 193 units
- Distribution
- Product was distributed to 40 hospitals
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LOX
- Firm FEI
- 3001452571
- Firm city
- Santa Rosa
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28