—#118543

Product

NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/210144 Dilation of the nephrostomy tract.

FDA product code: LJE — Catheter, Nephrostomy
Device class: Class U
Medical specialty: Unknown
510(k) numbers: K121614
Affected lot / code info: Lot Number: 15875861, 15875860, 15875299, 15872797, 15872799, 15872798

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

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

Timeline

Recall initiated: 2013-05-28
Posted by FDA: 2013-07-09
Terminated: 2014-01-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118543. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.