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CRE Wireguided recallZ-2636-2026 · Boston Scientific Corporation · initiated May 21, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential sterile breach of the pouches in which devices are packaged.

FDA root cause category: Package design/selection

What the company 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.

Recall details

Recall number
Z-2636-2026
Status
Open, Classified
Initiated by the company
May 21, 2026
Posted by the FDA
Jul 1, 2026
Recalling firm
Boston Scientific Corporation
Quantity
81,543 units
Product code
FDT
FDA submissions
K110833
Distribution
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.

Product description

CRE Wireguided 15-18mm 240cm

Code information (models, lots, serial numbers)

UPN: M00558490; GTIN: 8714729339427; Lot No. 38033568, 38033569, 38033570, 38033571, 38047498, 38047722, 38047731, 38200167, 38239090, 38325015, 38325016, 38325017, 38413205, 38413206, 38413207, 38413208, 38413214, 38422540, 38422541, 38422542, 38422543, 38479759, 38507303, 38507304, 38519497, 38519498, 38529540, 38529541, 38529542, 38529543, 38529544, 38585005, 38585006, 38647771, 38790079, 38817673, 38817674, 38817675, 38817676, 38817677, 38817678, 38817679; Exp. October 24, 2028 February 9, 2029.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 99067).

Sources and updates

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