Terminated

Boston Scientific, Renegade Fiber Braided Microcatheter, Peripheral Vascular Use, RX Only, Sterilized using ethylene oxide, Legal Manufacturer: Boston Scientific Cork Ltd., Business & Technology Park, Model Farm Road, Cork, Ireland. Material Catalog # Description M001182480 18-248 RENEGADE 105/3.0/2.5/.021/20/STRAIGHT M001182510 18-251 F/G RENEGADE 150/10/1TIP M001182520 18-252 F/G RENEGADE 130/20/1TIP M001182530 18-253 F/G RENEGADE 150/20/1TIP

FDA Recall Z-2246-2009 · Posted 2009-09-24

Recalling FirmBoston Scientific Corporation

Recall StatusTerminated

Product CodeKRA

Date Initiated2009-08-26

Date Terminated2012-08-24

Product Quantity28,947 (11,050 US; 17,897 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.

K020012MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETERBoston Scientific/Medi-Tech · 2002-01-29

Official Source

View FDA Recall →

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