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Terminated

Boston Scientific Expo, Angiographic Catheter, Sterilized with ethylene oxide gas, Made in Mexico, Parque Industrial La Mesa, Edificion G1, Suites B. H, Tijuana, Baja California 22650 MEX. Boston Scientific Guide Catheters are intended for use in general intravascular and coronary applications. They provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in cerebral vasculature.

FDA Recall Z-2015-2009 · Posted 2009-09-04

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeDQO
Date Initiated2009-08-05
Date Terminated2012-01-07
Product Quantity367,898 (US 167,496; OUS 224,292)

Reason for Recall

Boston Scientific is initiating a recall removal of numerous batches/lots of Wiseguide Guide Catheter, Impulse Angiographic (Diagnostic) Catheter, Expo Angiographic (Diagnostic) Catheter. Boston Scientific has determined that the sterile barrier in the packaging may be compromised. During internal inspections, they discovered gaps between the side seals and the top seal approximately 3/8 in len

Firm Action

Boston Scientific issued an "Urgent Medical Device Recall Removal" letter dated August 5, 2009. The letter was addressed to Risk Manger / Field Action Contact. The letter described the problem and product involved. The Firm recommended to segregate affected product immediately and return to Boston Scientific and requested return of the "The Reply Verification Tracking Form" enclosed with the letter. For further questions, contact your local Boston Scientific Sales Representative or call 1-763-494-1634.

Root Cause

Packaging

Distribution Pattern

Worldwide Distribution -- US (including DC and Puerto Rico), Japan, United Arab Emirates, Albania, Austria, Belgium, Bulgaria, Bahrain, Switzerland, Czech Republic, Germany, Denmark, Algeria, Egypt, Spain, Finland, France, Great Britain, Greece, Hungary, Ireland, Israel, Iraq, Iceland, Italy, Jordan, Kuwait, Lebanon, Lithuania, Libya, Morocco, Netherlands, Norway, Pakistan, Poland, West Bank Gaza Strip/ Palestine, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Slovakia, Syria, Turkey, Ukraine, South Africa, Argentina, Australia, Brazil, Canada, Chile, Colombia, Dominican Republic, Ecuador, Guatemala, Indonesia, India, South Korea, Mexico, Malaysia, Nicaragua, New Zealand, Panama, Philippines, Puerto Rico, Paraguay, Singapore, El Salvador, Thailand, Taiwan, Uruguay, American Virgin Islands and Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K934541SCIMED 6 FRENCH ANGIOGRAPHIC CATHETER MODIFICATIONScimed Life Systems, Inc. · 1994-05-12K934581SCIMED 5, 7, AND 8 FRENCH ANGIOGRAPHIC CATHETERSScimed Life Systems, Inc. · 1994-03-31

Official Source

View FDA Recall →

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

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