CRE Pro Wireguided esophageal stent device recalled for packaging sterility
Boston Scientific is recalling CRE Pro Wireguided 18-20mm 240cm esophageal stents due to potential sterile breach of product pouches. The breach could allow contamination of sterile devices.
What this means for you
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. The source states only a potential sterile breach with no reported illnesses or injuries, making it a theoretical risk of harm to a high-risk product category (implantable medical device). Per the rubric, this justifies a High (3) severity.
Plain-English summary
Boston Scientific Corporation is recalling the CRE Pro Wireguided 18-20mm 240cm esophageal stent device due to a potential sterile breach of the pouches in which the devices are packaged.
The recall affects 81,543 units distributed worldwide, including across the United States and to numerous international destinations. Affected lots include devices with expiration dates ranging from November 23, 2028 to March 29, 2029.
Healthcare providers who have received affected units should stop using them immediately and consult the product's instructions for proper handling. Patients who have had this device implanted should contact their healthcare provider if they have any concerns.
The recalled product
- Product
- CRE Pro Wireguided 18-20mm 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: M00558710
- GTIN: 8714729797593
- Lot No. 38031485
- 38031486
- 38031487
- 38031488
- 38031489
- 38031490
- 38031642
- 38031643
- 38031644
- 38031645
- 38043600
- 38043601
- 38043602
- 38043603
- 38043604
- 38055580
- 38055581
- 38055582
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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