Boston Scientific Corporation One Boston Boston Scientific PCNL (Percutaneous Tract) Kit with Nephromax Balloon; Part Number: M0064501110 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Boston Scientific PCNL (Percutaneous Tract) Kit with Nephromax Balloon; Part Number: M0064501110
Brand
Boston Scientific Corporation One Boston
Lot Codes / Batch Numbers
Batch/Lot Numbers: 8529320, 8568190, 9371965
Products Sold
Batch/Lot Numbers: 8529320, 8568190, 9371965
Boston Scientific Corporation One Boston is recalling Boston Scientific PCNL (Percutaneous Tract) Kit with Nephromax Balloon; Part Number: M0064501110 due to Mislabeled: Outer box unit has correct part number but product is incorrectly identiified as a Percutaneous Tract Kit with Nephromax Balloon. The box . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mislabeled: Outer box unit has correct part number but product is incorrectly identiified as a Percutaneous Tract Kit with Nephromax Balloon. The box actually contains a Percutaneous Tract Kit with Amplatz Dilator and Sheath Kit
Recommended Action
Per FDA guidance
Boston Scientific notified customers on 4/11/07 by letter via Federal Express mail. Users are requested to return product in inventory.
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 noticeDistribution
As reported by FDA
MD, MS, NM, OH, TX
Page updated: Jan 10, 2026