Z-0889-2007

Boston Scientific PCNL (Percutaneous Tract) Kit with Nephromax Balloon; Part Number: M0064501110

Name: Z-0889-2007 Boston Scientific PCNL (Percutaneous Tract) Kit with Nephromax Balloon; Part Number: M0064501110
Creator: Boston Scientific Corporation
Published: 2007-04-11
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2007-04-11 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Corporation began a recall of Boston Scientific PCNL (Percutaneous Tract) Kit with Nephromax Balloon; Part Number: M0064501110 on 2007-04-11. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0889-2007
Status: Terminated
Initiated: 2007-04-11
Posted: 2007-06-05
Terminated: 2007-12-12
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific PCNL (Percutaneous Tract) Kit with Nephromax Balloon; Part Number: M0064501110
Product code: LJE Catheter, Nephrostomy
Reason for recall: 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
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Boston Scientific notified customers on 4/11/07 by letter via Federal Express mail. Users are requested to return product in inventory.
Quantity in commerce: 15 kits
Distribution: Worldwide Distribution; USA including states of OH, MS, NM, MD, and TX and Foreign country of Trinidad
Product codes and lots: Batch/Lot Numbers: 8529320, 8568190, 9371965

Product code LJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)