FDA Medical Device Recalls (openFDA)
Cordis Neurovascular, Inc.: Product is labeled as Cordis Pre-shaped Prowler Plus MP Infusion Catheter (3 F proximal OD, 2.3 F Distal OD, 45 cm distal length, total length 155 cm) with an MP (45 degree) dual marker band tip. Also the package states that it is distributed by Cordis Endovascular systems, Inc, Miami, FL 33102 a Johnson & Johnson Company.
- Recall number
- Z-0018-04
- Recalling firm
- Cordis Neurovascular, Inc.
- Product
- Product is labeled as Cordis Pre-shaped Prowler Plus MP Infusion Catheter (3 F proximal OD, 2.3 F Distal OD, 45 cm distal length, total length 155 cm) with an MP (45 degree) dual marker band tip. Also the package states that it is distributed by Cordis Endovascular systems, Inc, Miami, FL 33102 a Johnson & Johnson Company.
- Status
- Terminated
- Initiated
- 2001-10-19
- Posted
- 2003-10-15
- Terminated
- 2004-05-11
- Reason
- These catheters have J-shape tips instead of the labeled MP (multipurpose) tips and also are packed into the incorrect tip tray.
- Root cause
- Other
- Action
- The firm initiated a recall of the product shipped to Japan via an e-mail notification on 8/20/2001 requesting return of the devices. The firm mailed recall notification letters to accounts in the United States on 10/19/2001. The firm considers the recall complete and effective and has accounted for all devices involved.
- Quantity
- 54
- Distribution
- Product was distributed to 4 US hospital accounts and to one Distirbutor in Japan.
- Lot, serial or model codes
- Catalog No. 606-2511 FX UPN H7396062511FX3 Lot T0601010, expiration date 2004-05
- 510(k) numbers
- K003925
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 1000222137
- Firm city
- Miami Lakes
- Firm state
- FL
- 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