Malecot Nephrostomy Catheter Set — Class II medical device recall Z-1101-2018
Terminated recall by Boston Scientific Corporation, reported 2018-03-28, distributed nationwide. Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
| Recall number | Z-1101-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2017-12-12 |
| Classified | 2018-03-18 |
| Reported by FDA | 2018-03-28 |
| Terminated | 2019-10-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BD, BO, BR, CA, CL, CN, CR, DO, EC, GT, KR, KW, LB, MX, MY, PA, PE, PH, SA, SG, SV, TR, VE, ZA |
| Quantity | 1,716 |
| UPC / GTIN / UDI-DI | 08714729005278 |
| Lot numbers | 16682347, 16893775, 16943409, 17003572, 17017122, 17075064, 17184857, 17192710, 17603504, 17703884, 17797369, 17990644, 18084498, 18095911, 18691891, 18705536, 18773341, 18876327, 18898595, 18987890, 19058167, 19515680, 19900108, 20094213, 20261038, 20312726, 20401204, 20458382, 20491743, 20517726, 20623819, 20658861, 20685659, 20735791, 20798226, 20830240, 20884480, 20909296, 20942365, 21055683 and 4 more |
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
Reason for recall
Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1101-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.