Boston Scientific Corporation recalls CRE Pro Wireguided 18-20mm 240cm
Reason for recall
Potential sterile breach of the pouches in which devices are packaged.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
CRE Pro Wireguided 18-20mm 240cm
Lot / code information
- GTIN
- 8714729797593
- Lot #
38031485, 38031486, 38031487, 38031488, 38031489, 38031490 — +143 moreShow all
38031485, 38031486, 38031487, 38031488, 38031489, 38031490, 38031642, 38031643, 38031644, 38031645, 38043600, 38043601, 38043602, 38043603, 38043604, 38055580, 38055581, 38055582, 38099704, 38099705, 38099706, 38099707, 38099709, 38099710, 38099711, 38099712, 38099713, 38099714, 38099715, 38110376, 38110377, 38110378, 38110379, 38131547, 38131548, 38150880, 38150881, 38150882, 38150883, 38162872, 38162873, 38162874, 38162875, 38169202, 38169203, 3818825438188255, 38193520, 38241877, 38241878, 38258885, 38258886, 38258887, 38258888, 38258889, 38278151, 38285220, 38285221, 38306689, 38306692, 38338285, 38338288, 38338290, 38338292, 38338294, 38338296, 38338297, 38338299, 38338301, 38347330, 38462126, 38462127, 38462128, 38462129, 38479753, 38479754, 38553523, 38553524, 38553525, 38608098, 38608099, 38612875, 38612876, 38612877, 38612878, 38622479, 38622600, 38622601, 38622602, 38622603, 38642700, 38642701, 38642702, 38642722, 38650472, 38665039, 38665260, 38665261, 38665262, 38665263, 38678316, 38678317, 38678318, 38678319, 38678760, 38702327, 38702328, 38702329, 38702330, 38702331, 38702332, 38709525, 38709526, 38709527, 38709528, 38734736, 38742717, 38742718, 38745588, 38745589, 38745590, 38748246, 38748247, 38748248, 38808893, 38808894, 38808897, 38808899, 38809140, 38823455, 38823456, 38823457, 38874308, 38874309, 38874310, 38874311, 38877005, 38877006, 38886252, 38886253, 38886254, 38886255, 38946205, 38946207, 38946209, 38959786, 38964092, 38964093; Exp. November 23, 2028 March 29, 2029
What the firm is doing
An Urgent Medical Device Removal - Immediate Action Required notification was mailed to consignees on 5/21/26. This notification informed consignees that Boston Scientific was conducting a removal of affected devices due to a potential sterile breach of product packaging (pouches). Consignees are instructed to immediately stop further use or distribution of product and quarantine them. Consignees are to complete and return the provided Reply Verification Tracking Form and return the product to Boston Scientific per the provided instructions. Consignees are to share the recall notification with any healthcare provider that uses the affected devices and with organizations to which product was further distributed. Consignees with any questions are to contact their Boston Scientific representative.
DistributionShow detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2631-2026
- FDA 510(k) clearance · K112994The device's official FDA premarket clearance record
- FDA device classification · FGEOfficial FDA classification for this device type
- CFR regulation · 21 CFR 876.5010The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Boston Scientific CorporationSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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