Z-0806-04

Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, Coronary...

Name: Z-0806-04 Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, Coronary...
Creator: Guidant Corp-Cpi Division
Published: 2004-03-11
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2004-03-11 / Terminated

FDA source

Guidant Corp-Cpi Division began a recall of Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, Coronary Sinus - Extended Hook Straight Right Tip Shape, CS-EH... on 2004-03-11. The reason FDA records is "The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery system components...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0806-04
Status: Terminated
Initiated: 2004-03-11
Posted: 2004-07-20
Terminated: 2005-10-31
Recalling firm: Boston Scientific Corporation
Product: Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, Coronary Sinus - Extended Hook Straight Right Tip Shape, CS-EH ST R, REF 7593
Product code: DQR Cannula, Catheter
Reason for recall: The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery system components during lead placement.
FDA root cause: Other
Action: Starting on March 11, 2003, the firm''s representatives visited consignees, to whom the recalled catheters had been consigned, and retrieved the catheters.
Quantity in commerce: 59 catheters
Distribution: Nationwide in the United States.
Product codes and lots: Lots 4012051, 4012851, 4021651, 4022151, and 4022351

Product code DQR

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)