Boston Scientific Corporation Boston Scientific (1) Flexima Regular Biliary Catheter System with RO Marker, 8 FR (2.7 mm) with Glidex hydrogel Coating Locking Pigtail and Radiopaque Marker, REF /Catalog No. 27-260 UPN; M001272600, Use before 2011-11, Sterilized with Ethylene Oxide Gas, Single Use Only, Made in USA 780 Brookside Drive, Spencer, IN 47460-1080. The catheter is designed for external and internal percutaneous drainage of the biliary system. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Boston Scientific (1) Flexima Regular Biliary Catheter System with RO Marker, 8 FR (2.7 mm) with Glidex hydrogel Coating Locking Pigtail and Radiopaque Marker, REF /Catalog No. 27-260 UPN; M001272600, Use before 2011-11, Sterilized with Ethylene Oxide Gas, Single Use Only, Made in USA 780 Brookside Drive, Spencer, IN 47460-1080. The catheter is designed for external and internal percutaneous drainage of the biliary system.
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
Lot Number: 12203269.
Products Sold
Lot Number: 12203269.
Boston Scientific Corporation is recalling Boston Scientific (1) Flexima Regular Biliary Catheter System with RO Marker, 8 FR (2.7 mm) with due to Boston Scientific is initiating a recall of a single batch/lot of this product. We received a report that the labeling on the device does not match t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Boston Scientific is initiating a recall of a single batch/lot of this product. We received a report that the labeling on the device does not match the labeling on the product packaging. Specifically, the packaging pouch for the product and outer carton labeling reflect that the device is a Flexima Biliary Catheter, which is correct, but the heat shrink inscription directly below the hub on the
Recommended Action
Per FDA guidance
Boston Scientific issued an "Urgent Medical Device Recall -Immediate Action Required" letter dated July 1, 2009. The letter was addressed to Risk Manger / Field Action Contact describing the problem and units affected and that further distribution or use of affected product should cease immediately. The Reply Verification Tracking Form enclosed with the letter was requested to be completed and returned. For further information, contact Boston Scientific at 1-508-683-6036.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026