Boston Scientific CRE Pro Wireguided catheters recalled for packaging
Boston Scientific is recalling CRE Pro Wireguided 6-8mm 240cm catheters worldwide due to a potential sterile breach in the packaging pouches, which could compromise device sterility.
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 sterile medical device with a potential sterility breach—a risk-of-harm hazard where no adverse events have been explicitly reported in the source text. Per the rubric, such cases without reported illness are scored as High (3).
Plain-English summary
Boston Scientific Corporation is recalling the CRE Pro Wireguided 6-8mm 240cm catheter due to a potential sterile breach of the pouches in which the devices are packaged. The affected products were distributed worldwide, including throughout the United States and to numerous international markets.
A total of 81,543 units are subject to this recall. The affected lot numbers are: 38031492, 38031493, 38031494, 38075351, 38078758, 38078759, 38130599, 38131540, 38131541, 38162878, 38187284, 38187285, 38204694, 38204695, 38204696, 38380212, 38380333, 38408115, 38408116, 38408117, 38408118, 38608097, 38622221, 38642730, 38678313, 38693569, 38770151, 38770152, 38864607, 38864608, 38906029, 38933949, 38960096, with expiration dates ranging from November 23, 2028 to March 29, 2029. The product's UPN is M00558660 and GTIN is 8714729797548.
Healthcare facilities and distributors in possession of affected units should cease use and contact Boston Scientific Corporation for instructions on how to proceed.
The recalled product
- Product
- CRE Pro Wireguided 6-8mm 240cm
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Catheter
- Hazard
- 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: M00558660
- GTIN: 8714729797548
- Lot No. 38031492
- 38031493
- 38031494
- 38075351
- 38078758
- 38078759
- 38130599
- 38131540
- 38131541
- 38162878
- 38187284
- 38187285
- 38204694
- 38204695
- 38204696
- 38380212
- 38380333
- 38408115
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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Same hazard · sterile breach
See all →- ModerateCRE Pro Wireguided Medical Device Recall for Sterile Packaging Breach
FDA (Devices) · 2026-07-08
- HighCRE Pro Wireguided 8-10mm 240cm Medical Device Sterile Pouch Breach
FDA (Devices) · 2026-07-08
- ModerateCRE Wireguided Device Recall Due to Potential Sterile Packaging Breach
FDA (Devices) · 2026-07-08
- ModerateCRE Wireguided 8-10mm 240cm Medical Device Recall Notice
FDA (Devices) · 2026-07-08
- HighCRE Pro Wireguided esophageal stent device recalled for packaging sterility
FDA (Devices) · 2026-07-08
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