Extractor Pro RX Retrieval Balloon Catheter incorrectly labeled
Boston Scientific Corporation is recalling Extractor Pro RX Retrieval Balloon Catheters because the label incorrectly indicates the position of the skive hole relative to the balloon.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a labeling discrepancy between the label instructions and the actual device design. The hazard is informational/operational mislabeling without reported illnesses or injuries, consistent with a Moderate severity classification.
Plain-English summary
Boston Scientific Corporation is recalling Extractor Pro RX Retrieval Balloon Catheters due to incorrect labeling. The product label indicates that the skive hole should be positioned above the balloon when it is actually positioned below, and vice versa.
This recall affects 156 units distributed nationwide to CA, CO, GA, ID, IL, IN, MA, ME, MI, MS, NC, OH, OK, PA, SD, TN, TX, VA, and WA. Two UPN (REF) codes are involved: M00547030 (9-12mm Below) with Lot Number 36398057, and M00547000 (9-12mm Above) with Lot Number 36426495.
Patients and healthcare providers who have this product should verify the actual position of the skive hole against the balloon before use to ensure correct device functionality. For questions or to report adverse events, contact Boston Scientific Corporation or the FDA.
The recalled product
- Product
- Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 156
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 (8)
- Instructions for Use: 51878205
- Pre-Printed Ouch: 51368417
- 1. UPN (REF): M00547030 (9-12mm Below)
- UDI-DI: 08714729790280
- Lot Numbers: 36398057
- 2. UPN (REF): (1) M00547000(9-12mm Above)
- UDI-DI: 08714729790266
- Lot Numbers: 36426495
Distribution
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