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Terminated

Boston Scientific Renegade" Hi-Flo Microcatheter, Peripheral Vascular Use. Sterilized with Ethylene Oxide. Legal Manufacturer: Boston Scientific Cork Ltd., Business & Technology Park, Model Farm Road, Cork, Ireland. M001182830 18-283 11961001 RENEGADE HI FLO 80/20 M001182840 18-284 11294909 RENEGADE HI FLO 105/10 M001182850 18-285 12703162 RENEGADE HI FLO 105/20 M001182860 18-286 11339895 RENEGADE HI FLO 115/10 M001182870 18-287 12669789 RENEGADE HI FLO 115/20 M001182880 18-288 11295844 RENEGADE HI FLO 135/10 M001182890 18-289 12703088 RENEGADE HI FLO 135/20 M001182900 18-290 11295637 RENEGADE HI FLO 150/10 M001182910 18-291 12684437 RENEGADE HI FLO 150/20 M001182980 18-298 11320970 RENEGADE HI FLO 105/10 KIT M001182990 18-299 12721456 RENEGADE HI FLO 105/20 KIT M001183000 18-300 11319972 RENEGADE HI FLO 115/10 KIT M001183010 18-301 12703082 RENEGADE HI FLO 115/20 KIT M001183020 18-302 11279134 RENEGADE HI FLO 135/10 KIT M001183030 18-303 11296276 RENEGADE HI FLO 135/20 KIT

FDA Recall Z-2244-2009 · Posted 2009-09-24

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeKRA
Date Initiated2009-08-26
Date Terminated2012-08-24
Product Quantity80,885 (51,491 US; 29,394 OUS)

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.

K023681RENEGADE STC 18 MICROCATHETERBoston Scientific Corp · 2002-11-26K000177RENEGADE 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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