Boston Scientific Corporation: CRE Wireguided 10-12mm 240cm

The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand: Boston Scientific Corporation
Product: CRE Wireguided 10-12mm 240cm
Reason / hazard: Potential sterile breach of the pouches in which devices are packaged.
Classification: Class II
Status: Ongoing
Distribution / sold at: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tobago, Trinidad, Tunisia, T¿rkiye, United Arab Emirates, Uruguay.
Recall initiated: 2026-05-21
Code info: UPN: M00558470; GTIN: 8714729339403; Lot No. 38099718, 38165001, 38165002, 38196568, 38196569, 38196570, 38204511, 38204512, 38204513, 38285933, 38397792, 38398767, 38398768, 38507308, 38552115, 38596881, 38596882, 38612829, 38612830, 38680058, 38683384, 38683385, 38689434, 38690171, 38707829, 38707830, 38710480, 38769697, 38800182, 38800183, 38871161, 38871162, 38871163, 38937571 ; Exp. November 2, 2028 February 23, 2029 .
Product quantity: 81,543 units
Voluntary mandated: Voluntary: Firm initiated
City: Marlborough
State: MA
Country: United States
Event id: 99067