Boston Scientific Boston Scientific mach 1 Guide Catheter, 8F, FCL 3.5 SH Femoral Curve Left 3.5, REF 34358-268, UPN H749343582680, 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Boston Scientific mach 1 Guide Catheter, 8F, FCL 3.5 SH Femoral Curve Left 3.5, REF 34358-268, UPN H749343582680, 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
Brand
Boston Scientific
Lot Codes / Batch Numbers
Lot/Batch # 572191
Products Sold
Lot/Batch # 572191
Boston Scientific is recalling Boston Scientific mach 1 Guide Catheter, 8F, FCL 3.5 SH Femoral Curve Left 3.5, REF 34358-268, UPN H due to Missing holes: Catheters are missing the catheter's side holes.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Missing holes: Catheters are missing the catheter's side holes.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
NY, PA
Page updated: Jan 10, 2026