CRE Wireguided 6-8mm 240cm Medical Device Recall Worldwide
Boston Scientific Corporation is recalling the CRE Wireguided 6-8mm 240cm device worldwide due to a potential sterile breach of the packaging pouches.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II medical device recall involving a sterile breach of packaging, which poses a potential risk of infection or contamination. Per the rubric, FDA Class II recalls are at minimum score 4 when the hazard involves breach of sterility in a device intended for internal use.
Plain-English summary
Boston Scientific Corporation is recalling the CRE Wireguided 6-8mm 240cm medical device due to a potential sterile breach of the pouches in which devices are packaged. This recall affects 81,543 units distributed worldwide, including throughout the United States and 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, Tobago, Trinidad, Tunisia, Türkiye, United Arab Emirates, and Uruguay.
The affected devices are identified by UPN M00558450 and GTIN 8714729339380, with specific lot numbers 38064056, 38064057, 38200574, 38200575, 38204501, 38204504, 38204506, 38204508, 38628161, 38640993, 38767490, 38904960, 38904961, 38946757, 38946758, and 38946759. Expiration dates range from October 27, 2028 to February 24, 2029.
Patients and healthcare providers should not use affected devices and should contact Boston Scientific Corporation for further instructions regarding replacement or return of recalled units.
The recalled product
- Product
- CRE Wireguided 6-8mm 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: M00558450
- GTIN: 8714729339380
- Lot No. 38064056
- 38064057
- 38200574
- 38200575
- 38204501
- 38204504
- 38204506
- 38204508
- 38628161
- 38640993
- 38767490
- 38904960
- 38904961
- 38946757
- 38946758
- 38946759
- Exp. October 27
- 2028 February 24
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.
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