Z-0305-04

Pentalumen TD Thermodilution Catheter, Sterile

Name: Z-0305-04 Pentalumen TD Thermodilution Catheter, Sterile
Creator: Abbott Laboratories HPD/ADD/GPRD
Published: 2003-11-19
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-11-19 / Terminated

FDA source

Abbott Laboratories HPD/ADD/GPRD began a recall of Pentalumen TD Thermodilution Catheter, Sterile on 2003-11-19. The reason FDA records is "Thermodilution catheters have a potential for ruptured lumens within the catheter". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0305-04
Status: Terminated
Initiated: 2003-11-19
Posted: 2004-07-20
Terminated: 2004-04-14
Recalling firm: Abbott Medical
Product: Pentalumen TD Thermodilution Catheter, Sterile
Product code: DYG Catheter, Flow Directed
Reason for recall: Thermodilution catheters have a potential for ruptured lumens within the catheter.
FDA root cause: Other
Action: Consignees were notified by letter on 11/19/2003.
Quantity in commerce: 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.
Product codes and lots: List No. 41233-01, Lot 04-187-SN

Product code DYG

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)