The Recall Desk
ModerateFDA (Devices)·Z-2618-2025·Announced 2025-10-01

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.

What this means for you

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
Category
Medical Device — Catheter / Retrieval Device
Hazard
  • labeling-error
  • mis-labeling

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

Distributed nationwide across the United States.

Related recalls

Same category