Re-Entry" Malecot Nephrostomy Catheter Set — Class II medical device recall Z-1103-2018
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-1103-2018 |
|---|---|
| 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 | 2,614 |
| UPC / GTIN / UDI-DI | 08714729192268 |
| Lot numbers | 16661359, 16749367, 16806828, 16861193, 17108329, 17184858, 17207012, 17226842, 17263721, 17303885, 17624941, 17642196, 17785597, 17858548, 17960226, 18095912, 18196369, 18220028, 18351957, 18484526, 18712075, 18773340, 18833032, 18876338, 18932471, 19066695, 19157075, 19235547, 19389756, 19468061, 19515681, 19596299, 19879546, 19962558, 19992214, 20017161, 20065717, 20119217, 20169832, 20198264 and 18 more |
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
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-1103-2018. 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.