Z-1673-2013Class II

NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number...

Name: Z-1673-2013 NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number...
Creator: Boston Scientific Corporation
Published: 2013-05-28
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2013-05-28 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 Dilation of the nephrostomy... on 2013-05-28. FDA classified it as Class II and gives the reason as "Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1673-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-28
Posted: 2013-07-09
Terminated: 2014-01-23
Recalling firm: Boston Scientific Corporation
Product: NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 Dilation of the nephrostomy tract.
Product code: LJE Catheter, Nephrostomy
Reason for recall: Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Boston Scientific, sent an "Urgent Medical Device Recall Removal - Immediate Action Required" letter dated May 28, 2013, consignees via Federal Express Priority Mail to its consignees/customers.OUS - Customer notification letters has also been sent to consignees/customers in the EU. The letter instructs the customers to Immediately discontinue use of and segregate recalled product; check their inventory; immediately remove all affected product from their inventory, and return it to Boston Scientific at Boston Scientific Corporation, US Distribution Center, Customer Fulfillment Center, 500 Commander Shea Blvd., Quincy, Massachusetts 02171 include original Verification Tracking Form and RGA #. The letter also requests the completion and return of the Account Reply Verification Tracking Form via email to: [email protected] or Fax to: Field Action Center 1-866-213-1806. Follow up communications will be made to the customers that do not respond to this inquiry. Distributors are instructed to forward the recall notification to their customers. If you have any questions call 763-494-1133 or email to [email protected].
Quantity in commerce: 15 units
Distribution: Worldwide distribution: USA (nationwide) including states of: NJ, NY, OH, IL, MI, MD, MA and countries of: Denmark, Great Britain, and Spain.
Product codes and lots: Lot Number: 15982017, 15963887, 16034014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1673-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1672-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-09
Z-1673-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-09

Product code LJE

K121614UnclassifiedNephromax High Pressure Nephrostomy Baloon Dilatation CatheterBoston Scientific Corp / cleared 2012-09-18

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)