Z-1103-2018Class II

Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268 The Malecot...

Name: Z-1103-2018 Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268 The Malecot...
Creator: Boston Scientific Corporation
Published: 2017-12-12
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2017-12-12 / Terminated

FDA source

Boston Scientific Corporation began a recall of Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268 The Malecot Nephrostomy Catheter Set is intended to establish... on 2017-12-12. FDA classified it as Class II and gives the reason as "Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1103-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-12
Posted: 2018-03-18
Terminated: 2019-10-24
Recalling firm: Boston Scientific Corporation
Product: Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268 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
Product code: GBO Catheter, Nephrostomy, General & Plastic Surgery
Reason for recall: Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
FDA root cause: Under Investigation by firm
Action: 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: [email protected] 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: [email protected] or [email protected].
Quantity in commerce: 2614
Distribution: 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.
Product codes and lots: Expiration Date Range: 1/14/2018 - 10/9/2021; Batch: 16661359 18712075 20198264 16749367 18773340 20312730 16806828 18833032 20350212 16861193 18876338 20425132 17108329 18932471 20491746 17184858 19066695 20517722 17207012 19157075 20624080 17226842 19235547 20653111 17263721 19389756 20703430 17303885 19468061 20740699 17624941 19515681 20769253 17642196 19596299 20884299 17785597 19879546 20942364 17858548 19962558 20968667 17960226 19992214 20995564 18095912 20017161 21046941 18196369 20065717 21071138 18220028 20119217 21157954 18351957 20169832 21241250 18484526

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1103-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1099-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-18
Z-1100-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-18
Z-1101-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-18
Z-1102-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-18
Z-1103-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-18
Z-1104-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-18

Product code GBO

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)