FDA Medical Device Recalls (openFDA)
Abbott Laboratories HPD/ADD/GPRD: Pentalumen TD Thermodilution Catheter, Sterile
- Recall number
- Z-0305-04
- Recalling firm
- Abbott Laboratories HPD/ADD/GPRD
- Product
- Pentalumen TD Thermodilution Catheter, Sterile
- Status
- Terminated
- Initiated
- 2003-11-19
- Posted
- 2004-07-20
- Terminated
- 2004-04-14
- Reason
- Thermodilution catheters have a potential for ruptured lumens within the catheter.
- Root cause
- Other
- Action
- Consignees were notified by letter on 11/19/2003.
- Quantity
- 495 units
- Distribution
- AR,AZ, CA, FL, LA, MA, NC, OR, PA, TN, TX, UT, VA, WA. VA facilities in AR,AZ,FL and NC. No military or foreign distribution.
- Lot, serial or model codes
- List No. 41233-01, Lot 04-187-SN
- 510(k) numbers
- ["K812800","K832957"]
- PMA numbers
- not on file
- Product code
- DYG
- Firm FEI
- 1415939
- Firm city
- Abbott Park
- Firm state
- IL
- 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