NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/21

FDA device recall Z-1672-2013 · posted 2013-07-09 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.

Action taken

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: MapleGroveFieldActionCenter@bsci.com 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 MapleGroveFieldActionCenter@bsci.com.

Root cause

Process control

Status

Terminated

Product code

LJE

Quantity affected

27

Distribution

Worldwide distribution: USA (nationwide) including states of: NJ, NY, OH, IL, MI, MD, MA and countries of: Denmark, Great Britain, and Spain.

Date initiated

2013-05-28

Date posted

2013-07-09

Date terminated

2014-01-23

Location

Marlborough, MA

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