Boston Scientific CRE Pro Wireguided 12-15mm Esophageal Stent Recall
Boston Scientific is recalling CRE Pro Wireguided 12-15mm 240cm esophageal stents due to a potential sterile breach in the device packaging. Affected units were distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a potential sterile breach of medical device packaging, which presents a risk of contamination and infection. No illnesses or injuries are reported in the source text, but the hazard involves a high-risk medical device used in an invasive procedure where sterility is critical.
Plain-English summary
Boston Scientific Corporation is recalling the CRE Pro Wireguided 12-15mm 240cm esophageal stent due to a potential sterile breach of the pouches in which the devices are packaged.
The recall affects 81,543 units distributed nationwide in the United States and internationally to 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, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, and Uruguay.
Affected lot numbers include 38031635 through 38933956. Expiration dates range from November 23, 2028, to March 25, 2029. Healthcare providers and patients who have received these devices should contact Boston Scientific Corporation or their healthcare provider for instructions on next steps.
The recalled product
- Product
- CRE Pro Wireguided 12-15mm 240cm
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 81,543
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UPN: M00558690
- GTIN: 8714729797579
- Lot No. 38031635
- 38031636
- 38031637
- 38031638
- 38031639
- 38031640
- 38031641
- 38043114
- 38043115
- 38053614
- 38053615
- 38053616
- 38078354
- 38188253
- 38200578
- 38211780
- 38214898
- 38214899
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
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