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Terminated

Boston Scientific Scimed Monorail Express 2 Coronary Stent System, 3.5 mm x 32 mm, Catalog number 35050-3235

FDA Recall Z-1123-03 · Posted 2003-08-12

Recalling FirmBoston Scientific Scimed
Recall StatusTerminated
Product CodeMAF
Date Initiated2003-07-16
Date Terminated2006-12-28
Product Quantity17 stent systems

Reason for Recall

There is an Increased potential for broken struts of the stents.

Firm Action

Consignees were sent a recall letter dated July 16, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.

Root Cause

Other

Distribution Pattern

The products were shipped to consignees located nationwide in the United States.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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