—#162286

Product

Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors

FDA product code: GBO — Catheter, Nephrostomy, General & Plastic Surgery
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Expiration Date Range: 12/10/2017 - 10/29/2021; Batch: 16602757 17989189 19103005 16632804 18000051 19156402 16668232 18071028 19272679 16687725 18187908 19323232 16701905 18238926 19338380 16725748 18312539 19374391 16746021 18347202 19419431 16768170 18403711 19510783 16769687 18453529 19543444 16791047 18467224 19596296 16813326 18511816 19622910 16861185 18522401 19652445 16886796 18631119 19672586 16911889 18702248 19824542 16918770 18702249 19884752 16931022 18705836 20001153 16931071 18780195 20091268 16964525 18800088 20118753 17143046 18818625 20198261 17227380 18820391 20288613 17399143 18900337 20321757 17446684 18900338 20477761 17604237 18955686 20753764 17659535 18977772 20789373 17670349 19006930 21009191 17710577 19087159 21046808 17766030 19097822 21316321 17826778

Why it was recalled

Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

The firm, Boston Scientific, sent an "Urgent Medical Device Product Removal - Immediate Action Required" letter dated 12/12/2017 to its consignees. The letter described the product, problem and actions to be taken. The consignees were instructed to: identify and remove all affected batches from your inventory; immediately discontinue use of and segregate the affected product, and return it to Boston Scientific. Distributors were notified that this removal is to the customer level and asked to notify any customers who received affected product. Consignees were asked to complete and return the Replay Verification Tracking Form (even if you do not have any product to return) via email: BSCFieldActionCenter@bsci.com or Fax to: Field Action Center at 1-866-213-1806. If you have any questions, your local Sales Representative can answer any questions that you may have regarding this removal or contact Vice President , Regulatory Affairs at 508-683-4398 or email: Donna.Gardner@bsci.com or BSCFieldActionCenter@bsci.com.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution: US (nationwide) in the following: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KA, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, including the District of Columbia and Puerto Rico; and countries of: Argentina, Bolivia, Brazil, Canada, Chile, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Mexico, Panama, Peru, Venezuela, Australia, Bangladesh, Botswana, China, Kuwait, Lebanon, Macau, Malaysia, Philippines, Saudi Arabia, Singapore, South Africa, South Korea, Turkey, United Arab Emirates, and Zimbabwe.

Timeline

Recall initiated: 2017-12-12
Terminated: 2019-10-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162286. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.