Z-0382-2007

Boston Scientific Mach 1 Guide Catheter Femoral Approach, 6F, 0.070'', Internal Mammary Curve, UPN #...

Name: Z-0382-2007 Boston Scientific Mach 1 Guide Catheter Femoral Approach, 6F, 0.070'', Internal Mammary Curve, UPN #...
Creator: Boston Scientific
Published: 2006-12-13
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2006-12-13 / Terminated

FDA source

Boston Scientific began a recall of Boston Scientific Mach 1 Guide Catheter Femoral Approach, 6F, 0.070'', Internal Mammary Curve, UPN # H74934356260, Catalog # 34356-26. Made in Mexico: Edificio... on 2006-12-13. The reason FDA records is "Excess strands of resin may exist in the lumen near the hub of certain batches/lots of the Mach 1 Guide Catheters. If this excess resin is present in the catheter, there is the potential of an embolization resulting...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0382-2007
Status: Terminated
Initiated: 2006-12-13
Posted: 2007-02-07
Terminated: 2007-06-28
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific Mach 1 Guide Catheter Femoral Approach, 6F, 0.070'', Internal Mammary Curve, UPN # H74934356260, Catalog # 34356-26. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa, Tijuana, Baja California 22650 MEX.
Product code: DQY Catheter, Percutaneous
Reason for recall: Excess strands of resin may exist in the lumen near the hub of certain batches/lots of the Mach 1 Guide Catheters. If this excess resin is present in the catheter, there is the potential of an embolization resulting from the excess resin detaching from the device during the procedure.
FDA root cause: Other
Action: An Urgent Medical Device Recall letter, dated 12/13/06, and a Clarification of Recall Notification letter, dated 12/14/06, were sent to all affected hospitals. The letter describes the issue, affected product, asks for customers to discontinue further distribution or use of any remaining product and asks for product to be returned. Replacement product will be available for any/all returned product.
Quantity in commerce: 3
Distribution: Nationwide.
Product codes and lots: Batch / Lot # 687532

Product code DQY

K010874Class II6F Mach 1, Model 34356-XxxBoston Scientific Corp / cleared 2001-06-21

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)