CRE Pro Wireguided Balloon Dilator
Boston Scientific recalls CRE Pro Wireguided balloon dilators over potential sterile pouch breach.
Check the device packaging for any signs of damage or breach. Do not use if the sterile pouch is compromised. Contact Boston Scientific for return and replacement instructions.
Why it was recalled
Boston Scientific is recalling CRE Pro Wireguided balloon dilators because the pouches in which the devices are packaged may have a sterile breach, compromising sterility. The recall affects sizes 6-8mm and 18-20mm, 240cm length.
Is mine affected?
This recall covers 12 products. Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | UPC | Recall # |
|---|---|---|
| CRE Pro Wireguided 12-15mm 240cm | 8714729797579, 38031635, 38031636, 38031637, 38031638, 38031639, 38031640, 38031641, 38043114, 38043115, 38053614, 38053615, 38053616, 38078354, 38188253, 38200578, 38211780, 38214898, 38214899, 38222485 | Z-2629-2026 |
| CRE Pro Wireguided 10-12mm 240cm | 8714729797562, 38031620, 38031621, 38031622, 38031623, 38031624, 38031625, 38031626, 38031627, 38031628, 38031629, 38031631, 38075353, 38078357, 38078358, 38078359, 38078740, 38078741, 38078742, 38078743 | Z-2628-2026 |
| CRE Pro Wireguided 15-18mm 240cm | 8714729797586, 38043116, 38192116, 38192117, 38192118, 38192119, 38192960, 38192961, 38214896, 38214897, 38222153, 38222496, 38222497, 38222498, 38222499, 38222660, 38222661, 38222662, 38222663, 38222664 | Z-2630-2026 |
| CRE Pro Wireguided 6-8mm 240cm | 8714729797548, 38031492, 38031493, 38031494, 38075351, 38078758, 38078759, 38130599, 38131540, 38131541, 38162878, 38187284, 38187285, 38204694, 38204695, 38204696, 38380212, 38380333, 38408115, 38408116 | Z-2626-2026 |
| CRE Wireguided 8-10mm 240cm | 8714729339397, 38064055, 38099717, 38100033, 38100034, 38164759, 38165000, 38165003, 38293337, 38293338, 38293339, 38333957, 38347335, 38347336, 38398764, 38398765, 38398766, 38529517, 38552112, 38552113 | Z-2633-2026 |
| CRE Wireguided 15-18mm 240cm | 8714729339427, 38033568, 38033569, 38033570, 38033571, 38047498, 38047722, 38047731, 38200167, 38239090, 38325015, 38325016, 38325017, 38413205, 38413206, 38413207, 38413208, 38413214, 38422540, 38422541 | Z-2636-2026 |
| CRE Wireguided 12-15mm 240cm | 8714729339410, 38033567, 38056239, 38056940, 38056941, 38215260, 38266854, 38266855, 38293330, 38391881, 38413876, 38413877, 38413878, 38413879, 38414080, 38422547, 38446204, 38466097, 38468862, 38468863 | Z-2635-2026 |
| CRE Wireguided 6-8mm 240cm | 8714729339380, 38064056, 38064057, 38200574, 38200575, 38204501, 38204504, 38204506, 38204508, 38628161, 38640993, 38767490, 38904960, 38904961, 38946757, 38946758, 38946759 | Z-2632-2026 |
+4 more affected products. See the full list at the official source below.
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Boston Scientific Corporation
Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification