—#85578

Product

Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-110 (M001171100). EQL/33/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K021721
Affected lot / code info: Lot: 11612503, 11613167, 11649850, 11664333, 11675647, 11679806, 11687184, 11703304, 11703305, 11706256, 11706257, 11721527, 11747701, 11748426, 11748427, 11753300, 11818319, 11822020, 11822021, 11823536, 11823537, 11838168, 11872757, 11880388, 11892722, 11894939, 11895181, 11895182, 11905798, 11942328, 11960758, 11973985, 11975229, 11975230, 11981138, 11981139, 11984930, 11992156, 11996764, 12003798, 12003799, 12060855, 12060857, 12065124, 12133643, 12140443, 12143888, 12143890, 12147789, 12159640, 12167057, 12183330, 12185881, 12215326, 12215327, 12227669, 12235732, 12235733, 12235734, 12280629, 12299197, 12299198, 12299199, 12303046, 12303579, 12307240, 12319312, 12319313, 12319314, 12351534, 12351536, 12397165, 12397166, 12400869, 12400870, 12400871, 12419731, 12423640, 12424849, 12424850, 12424851, 12432156, 12438763, 12438764, 12438765, 12438766, 12438767, 12442597, 12535285, 12535286, 12582189, 12582625, 12590510, 12598481, 12598482, 12598483, 12598484, 12617284, 12617285, 12625391, 12625392, 12625393, 12636765, 12636766, 12640395, 12640396, 12640397, 12640398, 12640399, 12685132, 12709946, 12709947.

Why it was recalled

Boston Scientific is initiating a Recall Removal of numerous batches/lots of Equalizer Occlusion Balloon Catheter because the sterile barrier in the packaging of the affected product may be compromised. The outer pouch seal may be breached. If a compromised seal is not detected and a sterility-compromised catheter is used clinically, there is a risk of adverse health consequences.

Root cause (FDA determination)

Other

Action the firm took

An Urgent Medical Device Recall Removal letter dated 09/29/2009 was sent to affected facilities and addressed to Risk Manager / Field Action Contact, beginning 09/29/2009. The letter explained the issue and identified product. Customers were asked to identify affected product within their inventory, segregate it and immediately return it to Boston Scientific. Customers will receive replacements for all recalled product that is returned. Customers were also to fax back to Boston Scientific the Reply Verification Tracking Form. Questions regarding this Recall Removal are directed to the local Sales Representative.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

Distribution pattern: Worldwide. US distribution includes: AL, AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT. NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Washington D.C. and Puerto Rico. Worldwide distribution includes: Algeria, Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Lithuania, Luxembourg, Malaysia, Morocco, Netherlands, Norway, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates.

Timeline

Recall initiated: 2009-09-29
Posted by FDA: 2009-11-13
Terminated: 2011-12-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85578. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.