FDA Medical Device Recalls (openFDA)
Medtronic, Inc.: Z2 Guiding Catheter 6 F JL3.5 SH Item No. : Z26JL35SH
- Recall number
- Z-0799-03
- Recalling firm
- Medtronic, Inc.
- Product
- Z2 Guiding Catheter 6 F JL3.5 SH Item No. : Z26JL35SH
- Status
- Terminated
- Initiated
- 2003-03-17
- Posted
- 2003-05-09
- Terminated
- 2008-02-19
- Reason
- The PTCA catheter is mislabeled: the curve style (Judkin Left vs. Judkin Right ) of the catheter may not correctly match the box label.
- Root cause
- Other
- Action
- Medtronic AVE notified the firm''s sales representatives on 3/17/03 by e-mail to retrieve affected product from the hospital and return it Danvers, MA. Each sales rep. is required to document the notification and accounting for the devices returned from the field.
- Quantity
- not on file
- Distribution
- AL, AR, KY, LA, MT, NH, NY, PA, WI Foreign: Japan, Hungary
- Lot, serial or model codes
- Lot Number: 122596
- 510(k) numbers
- ["K981198"]
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 1220452
- Firm city
- Danvers
- Firm state
- MA
- 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