Malecot Nephrostomy Catheter Set — Class II medical device recall Z-1100-2018
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-1100-2018 |
|---|---|
| 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 | 1,480 |
| UPC / GTIN / UDI-DI | 08714729005261 |
| Lot numbers | 16682515, 16954904, 17023624, 17174677, 17547901, 17634224, 17797370, 17881031, 17990643, 18006579, 18141765, 18280356, 18351959, 18518065, 18662849, 18689958, 18773158, 18821699, 18898592, 19103570, 19134817, 19185066, 19235546, 19368679, 19879547, 20221526, 20491742, 20593965, 20703428, 20798225, 20824604, 20872724, 20995561, 21055681, 21101919, 21179390 |
Product
Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261 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-1100-2018. 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.