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

Extractor Pro RX Retrieval Balloon Catheter Recalled for Labeling Error

Boston Scientific is recalling 156 units of Extractor Pro RX Retrieval Balloon Catheter due to a labeling error that incorrectly describes the skive hole position relative to the balloon.

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 FDA Class II recall involves a labeling error on a medical device. While no injuries have been reported, the incorrect description of component positioning creates a risk of improper device placement and use, fitting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Boston Scientific Corporation is recalling 156 units of the Extractor Pro RX Retrieval Balloon Catheter. The recall involves two models: M00547030 (9-12mm Below, lot 36398057) and M00547000 (9-12mm Above, lot 36426495). The products were distributed nationwide in 19 states: California, Colorado, Georgia, Idaho, Illinois, Indiana, Massachusetts, Maine, Michigan, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, and Washington.

The recall is due to a labeling error. The Instructions for Use incorrectly describe the position of the skive hole relative to the balloon. The label indicates the skive hole should be positioned above the balloon, but it is actually positioned below—and vice versa. This discrepancy between the labeling and the actual product configuration could result in improper device use if healthcare providers follow the incorrect instructions.

Affected healthcare facilities and providers should cease use of the recalled units and contact Boston Scientific Corporation immediately. The FDA has classified this as a Class II recall.

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
Hazard
  • mis-labeling
  • device-positioning

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