Z-1101-2018Class II

Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 The Malecot Nephrostomy...

Name: Z-1101-2018 Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 The Malecot Nephrostomy...
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 Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous... 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-1101-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-12
Posted: 2018-03-18
Terminated: 2019-10-24
Recalling firm: Boston Scientific Corporation
Product: Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 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: 1716
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: 1/22/2018 - 10/4/2021; Batch: 16682347 18705536 20623819 16893775 18773341 20658861 16943409 18876327 20685659 17003572 18898595 20735791 17017122 18987890 20798226 17075064 19058167 20830240 17184857 19515680 20884480 17192710 19900108 20909296 17603504 20094213 20942365 17703884 20261038 21055683 17797369 20312726 21129580 17990644 20401204 21157953 18084498 20458382 21179391 18095911 20491743 21218849 18691891 20517726

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1101-2018
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)