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Terminated

Boston Scientific Renegade" Hi Flo Microcatheter (neurovascular use) REF 18-288OUS, Sterilized using ethylene oxide, Legal Manufacturer, Boston Scientific Corporation, One Boston Scientific Place, Natick, MA Made in Ireland, Business & Technology Park, Model Farm Road, Cork, Ireland. Material Catalog # Description M001182570 18257 Renegade" 18 150/10 (2-tip marker) M001182590 18259 Renegade" 18 150/20 (2-tip marker) M003182880US0 182880US Neuro Renegade" Hi Flo" 135/10 M003182890US0 182890US Neuro Renegade" Hi Flo" 135/20 M003182900US0 182900US Neuro Renegade" Hi Flo" 150/10 M003182910US0 182910US Neuro Renegade" Hi Flo" 150/20

FDA Recall Z-2245-2009 · Posted 2009-09-24

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeKRA
Date Initiated2009-08-26
Date Terminated2012-08-24
Product Quantity9,088

Reason for Recall

Boston Scientific has determined that the sterile barrier in the packaging of the affected product may be compromised. It has been reported that the pouch seal (top seal) may be breached.

Firm Action

Consignees were sent a Boston Scientific Urgent Medical Device Recall Removal - Immediate Action Required letter Dated August 26,2009. The letter was addressed to Risk Manager / Field Action Contact. The letter described the problem and product involved. Advised consignees to segregate the affected product and return it to Boston Scientific. Requested the return and completion of The Account Reply Verification Tracking form enclosed. Replacements will be issued for all recalled product that is properly returned to Boston Scientific.

Root Cause

Packaging

Distribution Pattern

Worldwide Distribution -- USA, excluding New Mexico and Wyoming, and countries of Europe, the Middle East and Africa, Japan, American Virgin Islands, Argentina, Aruba, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dutch Antilles, Egypt, Finland, France, Georgia, Germany, Great Britain, Greece, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Latvia, Libya, Luxembourg, Macau, Malaysia, Mexico, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Poland, Portugal, Puerto Rico, Romania, Saudia Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, and Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K000177RENEGADE HI-FLO MICROCATHETERBoston Scientific Corp · 2000-04-07

Official Source

View FDA Recall →

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

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