Z-0104-2008

Boston Scientific mach 1 Guide Catheter, VL3.5 SH Voda Left 3.5, REF 34358-78, UPN H74934358780, Sterile EO...

Name: Z-0104-2008 Boston Scientific mach 1 Guide Catheter, VL3.5 SH Voda Left 3.5, REF 34358-78, UPN H74934358780, Sterile EO...
Creator: Boston Scientific
Published: 2007-09-11
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2007-09-11 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific began a recall of Boston Scientific mach 1 Guide Catheter, VL3.5 SH Voda Left 3.5, REF 34358-78, UPN H74934358780, Sterile EO, Made in Mexico Avenida Norske Edicficio G1, Local... on 2007-09-11. The reason FDA records is "Missing holes: Catheters are missing the catheter's side holes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0104-2008
Status: Terminated
Initiated: 2007-09-11
Posted: 2007-10-27
Terminated: 2008-02-24
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific mach 1 Guide Catheter, VL3.5 SH Voda Left 3.5, REF 34358-78, UPN H74934358780, Sterile EO, Made in Mexico Avenida Norske Edicficio G1, Local B y H Parque Industrial La Mesa, Fracc. Rubio La Mesa, Tijuana, B.C. Mexico C.P. 22550
Product code: DQY Catheter, Percutaneous
Reason for recall: Missing holes: Catheters are missing the catheter's side holes.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: A voice mail was left to affected members of the domestic sales force on September 11, 2007 and an interoffice memo with the recall implementation instructions was also sent to the Sales Force. An Urgent Voluntary Medical Device Recall letter dated September 11, 2007, was sent to affected consignees describing the problem and products affected. The letter included the customer steps for recall, a Reply Verification Tracking Form and a return shipping label.
Quantity in commerce: 7
Distribution: Worldwide: NY, PA, and Japan
Product codes and lots: Lot/Batch # 559022

Product code DQY

K020028Class II6F Mach1/34356-Xxx; 5F Mach1/35845-Xxx; 7F Mach1/34357-Xxx; 8F Mach1/34358-XxxBoston Scientific / cleared 2002-01-22

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)